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Abstract of dissertation entitled
"An Evidence-based Guideline of Using Diet Control and Exercises
to Prevent Obesity Among Postpartum Women"
Submitted by
Yu Shun Yin
for the Degree of Master of Nursing at The University of Hong Kong
in July 2016
Body weight gain during pregnancy of women is common. Usually, the women have their
weight gain reduced after delivery. However, there are a certain number of mothers only have
small extent of weight reduction within one or two years after delivery. It is found that
women who gain and retain excessive weight in perinatal period have a greater risk to
become overweight or obese 21 years after the pregnancy (Mamum et al., 2010). This
overweight might cause the women to develop chronic diseases like heart diseases, diabetes
mellitus and hypertension (World Health Organization [WHO]).
There are studies showing that the combined method of diet control and exercises would
facilitate body weight reduction among overweight or obese postpartum women. By means of
collecting current evidences, conducting a comprehensive review of the selected studies, and
assessing the implementation potential of practice in maternal and child health centers
(MCHCs), an evidence-based guideline for a structured individual counseling at six week
postpartum for the overweight and obese women was established. To minimize the resistance
on the change of current practice, plans of communications with stakeholders, pilot study and
evaluation were developed. The aim of this study is to help health professionals to provide
competent and effective counseling to the mothers.
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Declaration
I declare that this dissertation represents my own work, except where due
acknowledgement is made. It has not been previously included in a thesis, dissertation, or
report submitted to this university or to any other institution for a degree, diploma, or other
qualifications.
Signed .................................
Yu Shun Yin
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Acknowledgements
I would like to take this opportunity to express my sincere gratitude to my dissertation
supervisor, Dr. Chung Oi Kwan Joyce, for her continuous encouragement, guidance and care
during the period that I worked on this dissertation. She gave me informative suggestions and
valuable advice contributing to every success of my study.
I am thankful to my classmates and colleagues for their considerate support during this
two years of the study. I am as well deeply grateful to my family for their constant love,
encouragement and support. Without their understanding and patience, it is impossible for me
to complete this study.
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Table of contents
Abstract .................................................................................................................................................... i
Declaration .............................................................................................................................................. ii
Acknowledgements ................................................................................................................................ iii
Table of contents ................................................................................................................................... iv
Chapter 1: Introduction .......................................................................................................................... 1
1.1 Background ................................................................................................................................... 1
1.2 Affirming Needs ............................................................................................................................ 3
1.3 Objective and Significance ............................................................................................................ 4
Objective ......................................................................................................................................... 4
Research questions ......................................................................................................................... 4
Stating the significance ................................................................................................................... 4
Chapter 2: Critical Appraisal ................................................................................................................... 6
2.1 Studies selection for Review ......................................................................................................... 6
Study selection criteria ................................................................................................................... 6
Exclusion criteria ............................................................................................................................. 6
Search strategy ............................................................................................................................... 7
2.2 Methodological Quality................................................................................................................. 7
2.3 Data Summary ............................................................................................................................. 10
Sample characteristics .................................................................................................................. 10
Intervention .................................................................................................................................. 11
Study Period .................................................................................................................................. 12
Intervention implementation ....................................................................................................... 12
General Outcomes ........................................................................................................................ 13
2.4 Data Synthesis ............................................................................................................................. 13
Target group .................................................................................................................................. 13
Intervention .................................................................................................................................. 14
2.5 Intervention implementation ..................................................................................................... 14
2.6 Implications ................................................................................................................................. 14
Chapter 3: Implementation Potential and Clinical Guideline ............................................................... 16
3.1 Transferability ............................................................................................................................. 16
Setting ........................................................................................................................................... 16
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Characteristics of Target Population ............................................................................................. 17
Philosophy of Care ........................................................................................................................ 17
Number of Clients Benefit from Innovation ................................................................................. 17
Time Frame of the Innovation ...................................................................................................... 18
3.2 Feasibility .................................................................................................................................... 18
Freedom to Carry Out Innovation ................................................................................................. 18
Interference with Current Staff Functions .................................................................................... 19
Support from Administration and Organizational Climate ........................................................... 19
Consensus among Nursing Staff and Administrators ................................................................... 20
Barriers on Carrying Out the Innovation and Support from Other Departments ........................ 20
Equipment Needed ....................................................................................................................... 21
Evaluation ..................................................................................................................................... 21
3.3 Cost‐Benefit Ratio of the Innovation .......................................................................................... 21
Potential Risk to Women .............................................................................................................. 21
Potential Benefits .......................................................................................................................... 21
Risk of Maintaining Current Practice ............................................................................................ 22
Cost of Innovation ......................................................................................................................... 22
3.4 Evidence‐Based Practice Guideline ............................................................................................. 23
Chapter 4: Implementation plan ........................................................................................................... 24
4.1 Communication plan ................................................................................................................... 24
Identification of stakeholders ....................................................................................................... 24
Communication process ............................................................................................................... 25
4.2 Pilot testing ................................................................................................................................. 26
4.3 Evaluation Plan ............................................................................................................................ 27
Identification of Outcomes ........................................................................................................... 27
Participants' eligibility ................................................................................................................... 28
Sample size consideration............................................................................................................. 29
Measurement ................................................................................................................................ 29
Data Analysis ................................................................................................................................. 30
Basis of an Effective Change of Practice ....................................................................................... 30
Chapter 5: Conclusion ........................................................................................................................... 31
References ............................................................................................................................................... I
Appendix A ‐ PRISMA Flow Diagram of Searches History ...................................................................... III
Appendix B ‐ Evidence Table .................................................................................................................. IV
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Appendix C ‐ SIGN Appraisal Checklist ................................................................................................. VIII
Appendix D ‐ Timelines for the program ............................................................................................. XIV
Appendix E ‐ Estimated material and non‐material costs of the innovation ........................................ XV
Appendix F ‐ Evidence‐based practice guideline ................................................................................. XVI
Appendix G ‐ SIGN Grading System Levels of Evidence and Grades of Recommendation .................. XIX
Appendix H ‐ Questionnaire ( For Mothers only) .................................................................................. XX
Appendix I ‐ Questionnaire ( For Nursing staff only) ........................................................................... XXI
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Chapter 1: Introduction
It is well documented that there is a strong association between obesity and various diet-
related chronic disorders. For example, hypertension, heart diseases, stroke, diabetes mellitus and
various cardiovascular diseases (WHO). Women usually have weight gain during pregnancy and
some of them lose their weight after delivery. However, some women only have small extent of
weight reduction within one or two years after delivery. Mamum et al. (2010) suggested that
women who gained excessive weight in perinatal period were at a greater risk of being
overweight or obese 21 years after the pregnancy.
The weight gain after pregnancy stage is defined to be the difference in body weight between
postpartum period and pre-pregnancy period (Institute of Medicine, 1990). Postpartum period or
puerperium represents the time after childbirth to the time the reproductive organs returning to
non-pregnant state for about six weeks (Medscape). Gore, Brown and West (2003) and Linne,
Barkeling and Rossner (2002) found that weight retained during pregnancy is associated with
overweight and obesity. To reduce the chance of developing obesity, early interventions on
weight management after pregnancy is necessary. One of the methods in controlling the weight
is to use diet control and exercises. This combined method was found to be beneficial to
overweight women. In this paper, we summarize and synthesize the best evidence-based practice
to prevent obesity among postpartum women.
1.1 Background
To objectively measure the status of body weight indicating the extent of obesity, one of the
methods is to use the body mass index (BMI). BMI is defined to be the quotient of the body
weight (in kilogram) and the square of the body height (in meter) (WHO). The WHO defined the
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standard of the BMI as BMI larger than or equal to 25 kg/m2 is considered to be overweight.
BMI 30 kg/m2 or above is classified as being obese. Meanwhile, the BMI standard for the Asian
is slightly different. The BMI ranging from 23 to 25 kg/m2 is classified to be overweight while
BMI above 25 kg/m2is considered as being obese (WHO/IASO/IOTF 2000).
In 2014, it is found that more than 1.9 billion adults with age larger than 18 were classified to
be overweight in the world. Meanwhile, 600 million out of the 1.9 billion were categorized to be
obese. For the women population, 15% of them were classified to be obese while 40% of them
were considered to be overweight (WHO). Rooney and Schauberger (2002) reported that women
who lost all the pregnancy weight by six months postpartum were found having weight gain at
2.4kg in 10 years after childbirth. Meanwhile, women who retained their pregnancy weight were
found to be 8.3kg heavier, which is more than triple the weight gain of the preceding group.
Therefore, they suggested that women who fail to achieve weight reduction gained at pregnancy
by six months postpartum had higher risk in developing long-term obesity. Linne and Rossner
(2003) reported that women retaining considerable amount of weight after childbirth have a
higher risk of sustaining the body weight in subsequent gestation. The gain in weight directly
increases the BMI which was found to be one of the major factors causing some non-
communicable diseases including heart diseases, hypertension, diabetes mellitus,
musculoskeletal disorders and some cancers like endometrial, breast and colon cancers (WHO).
It is believed that postpartum weight retention is associated with many factors including
parity, low socio-economic status, and high pre-pregnancy BMI (Crowell, 1995; Zanotti, Capp &
Wender, 2015). In addition, increase in dietary intake and reduction in exercise frequency are
also a common reason (Melzer & Schutz, 2010). Krummel (2007) considered postpartum period
is a vulnerable period for weight gaining.
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To handle this postpartum weight retention problem, some researchers proposed to intervene
during pregnancy which helps women gaining appropriate amount of weight. However, it is a
controversial intervention that there is a strong relationship between maternal weight gain and
fetal birth-weight (Abrams, 1993). Another approach is to help women to reduce excessive
weight gained during postpartum period. Diet control and exercises are usually recommended
methods in reducing excessive weight.
1.2 Affirming Needs
In Hong Kong, the portion of population suffering overweight is high. According to the
Behavioural Risk Factor Survey conducted by Department of Health in April 2014, 39.0% of the
adults with age ranging from 18 to 64 were found to be overweight or obese. I.e. their BMI were
above 23 kg/m2 according to the BMI standard for Asian (WHO/IASO/IOTF 2000). If we
consider only the female population, there was 29.5% women found to be overweight or obese.
Obesity cost 3.36 billion for hospitalization owing to the complications of chronic diseases in
Hong Kong (Ko, 2008), which is an economic burden on the healthcare system.
Hong Kong government provides a range of postnatal checkup services for the women after
delivery in the Maternal and Child Health Centre (MCHC). The checkup includes measurement
of body weight, body height, and blood pressure. Physical examination by doctors on the
recovery of reproductive organs is also included. However, if the BMI is found to be larger than
23kg/m2 (which is classified to be overweight), there is no follow up intervention provided. With
reference to the observational statistics, every month has about 40% of the women found to be
overweight or obese in 2015. Usually, the overweight women do not realize the problem of
overweight and are accustomed to their body image. In the future, the risk of having diet-related
chronic disorders is higher than non-overweight case and constitutes a threat to the health of the
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women. In view of this, an intervention program with diet control and exercises appears to be an
attractive method, which is feasible and inexpensive, in helping the women with overweight
problem.
1.3 Objective and Significance
Objective
The objectives of this translational nursing research are:
- To determine an intervention of using diet control and exercises for postpartum women to
prevent obesity,
- To find an evidence-based intervention from the reviewed literatures, and
- To develop a guideline for protocol implementation.
Research questions
How efficient diet control and exercises program is in weight reduction among postpartum
women who are overweight or obese in the community?
Stating the significance
Overweight or obese postpartum women
There are strong evidences showing that diet control and exercises manage to help women
losing weight. In long term, the intervention can lower the risk of developing diet-related chronic
disorders.
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Health-care Professionals
In long term, overweight and obesity may result in the development of serious diseases like
stroke. Our proposed intervention promoting diet control and exercises for the women in
postpartum period can reduce the body weight and reduce the risk in developing the serious
chronic diseases. Therefore, nurses can engage more time in promoting health to the public that
can further prevent people from developing chronic diseases.
Hospitals
Our proposed intervention making use of diet control and exercises manages to help
overweight and obese women in postpartum period to lower the body weight. Thus, the risk of
developing chronic diseases in long term is lowered and the medical cost of hospitals will be
reduced.
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Chapter 2: Critical Appraisal
In this chapter, a discussion about the method in selecting the studies is given. The selection
process is based on three issues: subject inclusion criteria, subject exclusion criteria and search
strategy of research papers. The research methods of the selected papers will be compared and
summarized in the form of a table of evidence, quality assessment, summary and synthesis.
2.1 Studies selection for Review
Study selection criteria
One of the primary selection criteria of the studies is that the study design is the randomized
controlled trials (RCT). The female participants recruited in the studies should be in the
postpartum period up to 24 months after childbirth and should be at least eighteen years old.
They should deliver a single, term and healthy baby.
In the studies, the diet interventions should include dietary counseling. For the exercise
interventions considered in the studies, it can be any method of exercise counseling. These may
be walking, jogging and any kind of sports promoting weight loss. For the control groups, there
should be no or minimal dietary and exercise education provided to the participants. The
evaluation method for the effect of the interventions should base on the weight loss of the
postpartum women.
Exclusion criteria
Female participants having postpartum complications, medical (e.g. hypertension, diabetes
mellitus) and surgical problems should be excluded.
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Search strategy
To search for studies relating to weight reduction in postpartum women, a systematic literature
search strategy was employed. Three electronic databases were searched: PubMed, CINAHL
Plus and Cochrane Library. We did not set a restriction on the publication year so as to include
the maximum number of relevant studies. In total, there were 347 articles found which included
235 articles from the PubMed, 102 articles from the CINIAHL Plus and 10 articles from the
Cochrane Library. The PRISMA flow diagram shown in Appendix A illustrates the details of the
search.
A range of keywords was used in the database search including "postpartum", "postnatal",
"overweight", "obese", "physical activity", "exercise", "diet", and "weight loss". Different
combinations of the keywords listed above were used during the article search. After screening
the titles and abstracts, there were 33 articles found relevant. However, 11 of them were not
using the RCT randomization method while 6 of them presented only the study design. 4 studies
had their intervention started during the pregnancy of the participants. 6 articles reported only the
feasibility or efficacy of outcome. Finally, 6 articles met all the inclusion criteria without
infringing the exclusion criteria listed above.
2.2 Methodological Quality
All the selected 6 articles were reviewed systematically and all of them used the randomized
controlled trial method. Evidence tables are formed to summarize the information of the 6
studies and are shown in Appendix B. The table of evidence includes the level of evidence, the
characteristics of subjects, intervention and comparison, the follow up length, outcomes
measures and effect size.
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The publication years of the 6 articles were from 1999 to 2012 and all of the 6 studies were
conducted in the developed countries. Four studies were done in the United States of America.
One was done in Sweden and one was carried out in the United Kingdom. All were published in
English. The sample sizes of the studies varied from 27 to 62 women and the length of the follow
up ranged from 11 days to 1 year. The key outcomes of all the studies included weight loss of
postpartum women.
All the 6 studies were assessed with the Scottish Intercollegiate Guidelines Network (SIGN)
appraisal checklists. Both the internal validity and overall assessment are assessed. 5 studies
attained the levels of evidence of "+" which means the evidence is acceptable while 1 study
attained the "++" which means the evidence is high quality. Appendix C shows the results of the
SIGN appraisal checklists.
The research questions of all the six studies were stated appropriately and clearly. All of
them addressed the purpose of the interventions which was to promote weight loss in postpartum
women. Five studies clearly stated the randomization methods and the participants were
randomized either into the intervention group or control group. Thus, the selection bias could be
minimized. Three studies had their participants being allocated by computerized randomization
procedure (Craigie, Macleod, Barton, Treweek & Anderson, 2011; Colleran, Wideman &
Lovelady, 2012; McCrory, Nommsen-Rivers, Mole, Lonnerdal & Dewey, 1999). One study used
random-number table (Lovelady , Garner, Moreno & Williams, 2000) while one study had the
subjects being randomized in blocks (Bertz et al., 2012). One study did not provide the method
of randomization (O'Toole, Sawicki & Artal, 2003).
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Two studies had adequate concealment (Colleran et al., 2012; O'Toole et al., 2003) which
ensured that the participants and the investigators were blind to the group allocation. The other
four studies did not mention about the concealment issue.
Only one study stated the single blinding treatment allocation as double blinding was not
possible. The trained lifestyle counsellor had to carry out the intervention after the group
assignment while the research assistant was blinded to the group assignment (Craigie et al.,
2011). The other five studies did not address the blinding procedure.
All studies clearly stated the composition of the intervention groups in comparison with the
control group and the difference between the intervention and control groups was investigated.
All the studies reported the drop-out rates. Four of them had less than 20% of drop-out rate in
either the intervention or control groups (Colleran et al., 2012; Lovelady et al., 2000; McCrory et
al., 1999; Bertz et al., 2012). The reasons of dropping out were pregnancy, taking metabolism
affecting drug, wanted weight loss, time constraints, unreported exercises induced asthma
condition, difficulty in completing baseline measurements, moved out of state, personal
problems causing not fully breastfeeding and stopped breastfeeding. Two studies had high drop-
out rates. One of the two studies had 31% drop-out rate (intervention group: 24% and control
group: 39%). The reasons for the drop-out were time constraints, illness/bereavement, unhappy
reallocation, no reason given and pregnancy (Craigie et al., 2011). The other study had drop-out
rate of 42.5% (intervention group: 38% and control group: 47%) with no reason reported
(O'Toole et al., 2003). None of the six studies mentioned the intention to treat.
All in all, one study achieved a high quality rating with a very low risk of bias and had high-
level evidence according to SIGN criteria (Colleran et al., 2012) as the researchers minimized
biases using randomization and concealment. The drop-out rate was below 20% and the outcome
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measurements were assessed by standard equipments procedures. The other five studies achieved
an acceptable quality rating with a low risk of bias. Four of them did not address well the
concealment and blinding issues (Craigie et al., 2011; Lovelady et al., 2000; McCrory et al.,
1999; Bertz et al., 2012). One of them did not well address the randomization and blinding issue
(O'Toole et al., 2003).
2.3 Data Summary
Sample characteristics
All the six studies were conducted in developed countries (Craigie et al., 2011; Colleran et
al., 2012; Lovelady et al., 2000; McCrory et al., 1999; O'Toole et al., 2003; Bertz et al., 2012).
One of them studied on the effect of the diet control and exercises in weight reduction for the
postpartum women living in areas of deprivation (Craigie et al., 2011). All of the studies except
one recruited postpartum women with BMI mean larger than 25 kg/m2 while the study of
McCrory et al. recruited participants with BMI mean ranging from 24.9 to 25.4 kg/m2 (McCrory
et al., 1999). Out of the six studies, three of them included only participants who were
exclusively breastfeeding their babies (Colleran et al., 2012; Lovelady et al., 2000; McCrory et
al., 1999), while one study included participants who were either exclusively or partially
breastfeeding their babies (Bertz et al., 2012).
Four studies conducted the intervention for the participants who were 4 week to 12 week
postpartum (Colleran et al., 2012; Lovelady et al., 2000; McCrory et al., 1999; Bertz et al., 2012).
Two studies included the participants who were 6-18 months postpartum (Craigie et al., 2011)
and 6 week to 16 months postpartum (O'Toole et al., 2003).
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Intervention
All the six studies provided the intervention with diet control and exercises. One of them had
two intervention groups: diet plus exercises group and diet group (McCrory et al., 1999). While
one study had three intervention groups in total: diet group, diet plus exercises group, and
exercises group (Bertz et al., 2012).
Interventions in all these studies provided individual counseling, dietary prescription and
physical activity plan. One of them had their intervention combined with telephone follow up
intervention (Craigie et al., 2011) and one of them combined with education group sessions
(O'Toole et al., 2003).
For the diet intervention, three studies proposed to reduce energy intake for 500 kcal
according to the participant's daily estimated required energy (Craigie et al., 2011; Bertz et al.,
2012; Lovelady et al., 2000), while the study of Colleran et al. (2012) had an addition 330 kcal
for breastfeeding and subtraction of 500 kcal (Colleran et al., 2012). One study proposed 35% of
net energy deficit from the daily estimated required energy including 60% by dietary restriction
and the other 40% by additional exercises (McCrory et al., 1999). No detail of diet prescription
was provided in the study of O'Toole et al. (2003).
For the exercise intervention, four studies provided aerobic exercise plan (Craigie et al., 2011;
Lovelady et al., 2000; McCrory et al., 1999; O'Toole et al., 2003). Two studies provided a
standardized walking or brisk walking plan (Colleran et al., 2012; Bertz et al., 2012). One of
them had additional strength training (Colleran et al., 2012). Two of the studies had their
participants provided with pedometers (Craigie et al., 2011; Colleran et al., 2012). All the studies
were self supervised training except Lovelady's study had the participants supervised by a
research assistant during exercise sessions (Lovelady et al., 2000).
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The frequency of the exercise in different studies varied. For Craigie et al. (2011) study, the
participants were provided with personalized 150 minutes weekly physical activity goals.
Colleran et al. (2012) proposed to have physical activity of 10,000 steps walking or 3000 aerobic
steps per day and to have the activity at least five days per week. In addition, the participants also
had strength training three times per week. For Lovelady et al. (2000) study, the participants had
aerobic exercises for 45 minutes per session for four times per week. The participants in the
study of McCrory et al. (1999) had aerobic exercises on average 86 minutes/session on 9 of 11
days. Bertz et al. (2012) proposed 45 minutes brisk walk 4 days per week. No detail of exercise
frequency was mentioned in the study of O'Toole et al. (2003).
Study Period
One study lasted for 11 days (McCrory et al., 1999). The studies of Lovelady et al. (2000),
Craigie et al. (2011) and Colleran et al. (2012) lasted for 10 weeks, 12 weeks and 16 weeks
respectively. Two studies lasted for 1 year (O'Toole et al., 2003; Bertz et al., 2012).
Intervention implementation
One study had both the diet and exercises interventions provided by trained lifestyle
counsellor (Craigie et al., 2011). For diet intervention, three of the studies had dietitians
providing counseling service (Colleran et al., 2012; O'Toole et al., 2003; Bertz et al., 2012). For
exercises intervention, two of the studies had physical therapist providing counseling (O'Toole et
al., 2003; Bertz et al., 2012). One study had a research assistant to supervise each exercise
session (Lovelady et al., 2000). Another one study had a research assistant came to the
participant's home for 1-3 times per week for guidance on exercise program and to ensure dietary
compliance (Colleran et al., 2012).
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General Outcomes
All studies except one showed significantly weight loss in the diet plus exercises group
(Craigie et al., 2011; Colleran et al., 2012; Lovelady et al., 2000; McCrory et al., 1999; O'Toole
et al., 2003). Bertz et al. (2012) showed weight loss in the diet plus exercises group, but the
result was not significant. Moreover, the studies of McCrory et al. (1999) and Bertz et al. (2012)
found significant weight loss in the diet group. However, the participants in the diet group were
also found that the fat-free mass in the study of McCrory et al. (1999) and the lean soft tissue
mass in the study of Bertz et al. (2012) had significant loss. In addition, the study of Bertz et al.
(2012) said that at baseline all participants in the three interventions groups and the control group
already met the recommended levels of physical activity at >8000 steps per day. This suggested
that the participants in this study were quite active and we should not ignore the benefit of
exercises.
2.4 Data Synthesis
After summarizing the information from the selected studies, successful weight reduction
interventions have following common settings:
Target group
The target population is the postpartum women who are overweight or obese and are being 4-
12 weeks postpartum as the four studies (Bertz et al., 2012; Colleran et al., 2012; Lovelady et al.,
2000; McCrory et al., 1999) had drop-out rate less than 20%. Two studies which recruited
women up to 18 months postpartum ended up with a relatively high withdraw rate and increased
the drop-out rate of the studies. (Craigie et al., 2011; O'Toole et al., 2003)
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Intervention
Individual counseling is conducted with dietary prescription and activity plan. For the diet
intervention, the dietary counseling will include energy restriction according to the participant's
estimated required daily energy intake. For the exercise intervention, the exercise plan can set to
target of walking 10,000 steps or 3000 aerobic steps per day with frequency at least 5 times/week.
These exercises are considered suitable for postpartum women, which are simple and accessible.
The practice of the exercises is suggested to be self-supervised as all studies except one
(Lovelady et al., 2000) performed self-supervised exercise intervention.
2.5 Intervention implementation
There were different professionals to carry out the implementation, including trained lifestyle
counsellor and dietitians to provide dietary counseling for diet intervention, and trained lifestyle
counsellor and exercise therapists to provide exercise counseling for exercise intervention. As
most of the studies managed to attain significant weight loss, it is suggested that the intervention
could be delivered by professionals who are trained for the knowledge of diet modification and
physical activity. Nurses can be the professional to deliver the intervention and they should be
provided with some short-term training on the aspects of diet and exercises.
2.6 Implications
In conclusion, postpartum women could achieve weight loss by means of diet and exercises
intervention through individual counseling with dietary prescription and physical activity plan.
The intervention could be carried out by trained health professionals, e.g. nurses, but does not
have the necessity to restrict to dietitian and exercise therapists. The diet and exercise
intervention is recommended to be practiced in Hong Kong in the community as overweight or
obesity is common among postpartum women. The MCHC should take the responsibility to
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provide intervention to the overweight postpartum women and to encourage them to practise. In
long term, the risk of developing chronic illnesses could be lowered and the medical cost in the
society could be reduced.
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Chapter 3: Implementation Potential and Clinical Guideline
After studying the six papers, the combined method of diet control and exercises is
reported to be effective in helping postpartum women reducing body weight and lowering the
chance of overweight in the future (Craigie et al., 2011; Colleran et al., 2012; McCrory et al.,
1999; Lovelady et al., 2000; Bertz et al., 2012; O'Toole et al., 2003). Therefore, this can
effectively lower the risks of developing various chronic diseases in long term. In this chapter,
we discuss the possibility to implement the intervention in Maternal and Child Health Centres
(MCHCs) in Hong Kong. The transferability and feasibility of the innovation are also discussed
and the cost-benefit ratio of this innovation in the healthcare setting is appraised.
3.1 Transferability
The target audiences are mothers who have undergone vaginal deliveries, nonsmoking, no
illness, at six weeks postpartum with BMI ranging from 23 to 30 kg/m2. The upper limit is set at
30 kg/m2 in order to limit the inclusion of women who might be unable to participate in exercises
or might have the risk of obesity-related conditions that need additional medical treatment. The
setting includes registered nurses and enrolled nurses. Nurses will be trained by a dietitian and a
physiotherapist. They will counsel the eligible mothers and instruct them to follow the advices at
home. Transferability of target population, philosophy of care and time frame will be discussed
as follows.
Setting
The combined method of diet control and exercises program from all the reviewed studies
were conducted in hospital-based clinical setting. In our innovation, we will have the program
conducting in MCHCs which is similar to the hospital-based setting.
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Characteristics of Target Population
The age of the participants in the six studies ranged from 18 to 44 which is similar to the
age of the target participants in MCHCs. The background educational level of the target
populations in the six studies were also similar to our innovation which are secondary school
education level or above. In the six studies, most of the mothers were primiparous and singleton
pregnancy, which are also similar to the target participants in MCHCs.
Philosophy of Care
In our innovation, we primarily focus on the health of the mothers. With new born babies,
mothers usually tend to pay much attention to caring the babies and neglect their health status.
This includes the need of having a balanced diet and sufficient exercises to control the body
weight. Our philosophy of care aims at enabling the mothers to prevent from being obesity by
means of a combination of exercise and diet control. The benefit brought by the innovation also
include improve well-being and development of stable emotion which can promote harmonious
environment in the families. (Norman, Sherburn, Osborne & Galea, 2010) This philosophy
matches well with the care philosophy of the MCHC which states that "to lead the community in
promoting the health and well-being of children, women and families in Hong Kong"
(Department of Health, 2006).
Number of Clients Benefit from Innovation
The innovation can benefit the mothers who have BMI ranging from 23 to 30 kg/m2 and
attending the postnatal check up service at six week postpartum. One MCHC in the western New
Territories region is chosen to implement the innovation. From the past statistics, the clinic has
approximately 150 mothers visiting for the postnatal check up service each month. There are
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approximately 40% of them are classified as overweight and around 80% of the clients meet the
inclusion criteria who are willing to join the program. Thus, it is estimated that each month has
about 48 mothers being benefited from the innovation.
Time Frame of the Innovation
It is expected that the innovation will need one and a half year for implementation.
Proposal preparation and staff training will take about three months. Piloting the program is
expected to take another three months. In the following three months, we implement the program.
Consents will be obtained from the participants. After the implementation, the participants will
be followed up either in MCHC or by phone. Data are collected in the next six months for
evaluation purpose. Finally, we expect to use three months to write the report. (Appendix D)
3.2 Feasibility
MCHCs always try the best in promoting health of children, women and families and
introducing new technology and techniques which are proven by researchers. In addition, the
innovation is cost-effective. Therefore, the feasibility of the innovation is high. It is a must to
obtain approval and support from the service head of Family Health Service of Department of
Health before carrying out the innovation.
Freedom to Carry Out Innovation
With the permission from the Family Health Service, the nursing staff in the MCHC have
the freedom to carry out the innovation. If potential problem was found which could harm the
target population, the nursing staff have the right to terminate the program.
19
Interference with Current Staff Functions
The innovation has no interference with the current staff functions. Generally speaking, the
combined method of diet control and exercises program preventing obesity among postnatal
women is a new practice in MCHC. Training is needed and has to be arranged properly. In order
to avoid affecting the manpower of normal daily work in MCHC, the training could be done
during the weekly clinic meetings for two sessions.
When the target mothers come to MCHC for postnatal check up interview, individual
counseling on diet control and exercise will be provided. All the exercise and diet control
measures are conducted outside the MCHC by the participants with exercise sessions at least 5
days per week. Subsequently, the participants are arranged to come back for follow up sessions
during their babies receiving vaccines at second, fourth and sixth month of age of the babies.
Phone follow up will be done in between visits or if the mother did not turn up during their
babies' vaccination. Therefore, there is no interference with current staff functions while more
time is needed for the additional counseling and the follow up. These additional workload issue
can be discussed with the nursing officers.
Support from Administration and Organizational Climate
The administration tends to support well-proved innovations and the nursing officers are
always keen to improve the care quality and to address the needs of the clients. The
organizational climate is also conducive for applying new research methods. Nurses are usually
encouraged to keep updating their knowledge and to provide the latest information to the clients.
20
Consensus among Nursing Staff and Administrators
Generally speaking, the nursing staff are eager to learn and apply new research knowledge
to improve the services to the clients. To reach a consensus among the nursing staff and the
administrators, it is important to show them the scientific evidences that the innovation can help
the mothers. The combined diet control and exercise intervention has strong evidences showing
the effectiveness on the mothers who are overweight. During the early postnatal period, the
mothers are usually busy with household chores and baby care. They usually pay less attention to
their overweight problem. In long term, this may lead to a range of chronic diseases. There are
strong evidences showing that having sufficient exercises and diet control in the postpartum
period manages to increase the chance avoiding overweight development in the future (Mottola,
2009). Therefore, with these strong evidences, the administrators and staff would support the
innovation and thus resistance among staff is usually less and a consensus is likely to be reached.
Barriers on Carrying Out the Innovation and Support from Other Departments
The major barrier in carrying out the innovation is to spare some time for staff training. The
training course for nursing staff is only two hours in length. The participating nurses will be
arranged to have training in two successive clinic meetings which are held on Wednesday every
week. Each session of the training has 1 hour in length. Based on the 'train the trainer' approach,
a dietitian and a physiotherapist are responsible for the training. Subsequently, those trained
nurses can be trainers for the other untrained participating nurses.
21
Equipment Needed
No special equipment is needed to implement the innovation. The program needs interview
rooms and digital physician scales with height rod. In MCHCs, there are sufficient number of
digital physician scales and have sufficient interview rooms for the counseling purpose.
Evaluation
A log book will be given to the participating mothers to record the exercise information and
body weight. Monthly follow up are done through interviews and phone calls. Mothers are
welcomed to call back if there is any query. The weight of the mothers are measured at their first
postnatal visit and at second, fourth and sixth month postpartum when they bring their babies to
MCHC for vaccination.
3.3 Cost-Benefit Ratio of the Innovation
Potential Risk to Women
There is no known risk for the targeted mothers and nursing staff reported in the six studies.
Potential Benefits
Under the innovation, the health benefits of the mothers can be achieved. If the innovation
is carried out in MCHC successfully, the body weight of the target mothers could be reduced. In
long term, the risk of developing chronic diseases can be lowered, e.g. diabetes mellitus,
musculoskeletal disorders, hypertension and some cancers like colon, endometrial and breast
cancers (WHO). In addition to the medical benefits, the mothers may also experience improved
well-being and energy, which can help providing positive baby care. (Norman et al., 2010)
22
Risk of Maintaining Current Practice
Without the innovation, the target mothers may not be aware of the importance of weight
control. Their body weight may be retained or raised and Mamum et al. (2010) found that they
have a greater risk of being overweight or obese in the future 21 years after delivery. This can
lead to a higher risk of developing various chronic diseases compared with other mothers. This
can be a burden to their health and as well a financial burden to the society.
Cost of Innovation
Some of the materials needed including private interview rooms are available in MCHCs.
MCHCs also supply related leaflets continuously. A log book will be distributed for each
participating mother for recording exercise information and body weight. A pedometer will be
given to each target mother for exercises. Base on a cost-benefit calculation (Appendix E), the
materials costs are $6,000 .
Concerning the non-material cost, the primarily cost is the manpower, the data analysis,
and the cost for the introduction and implementation of the proposed innovation. Meanwhile,
there is only staff salary cost for implementing the program. The total cost for staff training and
manpower is $58,800 (Appendix E).
In spite of the fact that the benefit of the innovation cannot be estimated in terms of money.
The potential benefit obviously outweighs the expenses. It is worthwhile to implement the
innovation as the cost is low (approximately $450/participant) which results in weight control of
the mothers. The potential medical savings in the future may as well exceed the estimated cost.
23
3.4 Evidence-Based Practice Guideline
The evidence-based practice guideline for the combined method of diet control and
exercise and the recommendations extracted from the previously reviewed studies are presented
in Appendix F. These recommendations were graded according to the Grades of
Recommendations from Scottish Intercollegiate Guidelines Network (2012) (Appendix G).
24
Chapter 4: Implementation plan
In this chapter, we describe the development of the implementation plan to facilitate a
smooth adoption of the intervention. We first identify all the stakeholders and develop a
communication plan. Subsequently, we design a pilot test to test the feasibility of the new
guideline. Finally, the method to evaluate the effectiveness of the proposed innovation in the
clinical setting is discussed.
4.1 Communication plan
Identification of stakeholders
To implement a new plan, stakeholders identification is very important. The success of a
new plan depends very much on the communication with the stakeholders (Behal & Bansal,
2013). Usually, a range of officers, including principal medical officer, senior medical officers,
senior nursing officers, medical officers, nursing officer in-charge and nursing officers, play an
essential role as they are responsible for making decisions in carrying out new plans. For
example, they take part in setting new guidelines and making necessary changes with continuous
evaluations. Meanwhile, they also control the allocation of resources and manpower.
Registered nurses and enrolled nurses are responsible to teach the clients the method in
applying the diet control and exercises. They also follow up the body weight of the clients and
provide support. Therefore, their comments and suggestions are also important for the new
program as well.
25
Communication process
Communication with the management
To implement the new program, it is necessary to obtain the permission of the management
team. This process involves three stages. In the first stage, we need to persuade the nursing
officer in-charge that our proposed innovation is useful and necessary. We present the underlying
reasons for the innovation, literature review, feasibility of the innovation and the potential
difficulties during implementation. If we manage to convince the nursing officer in-charge, she is
going to help persuading the high level management including the senior medical officers and
the senior nursing officers in the second stage.
In the second stage, we need to prepare a proposal and submit it to the high level
management. The proposal includes the principal of innovation, feasibility, transferability, cost-
benefit ratio and an evaluation plan of the innovation. It is important that the proposed
innovation does not interfere with the existing working function in the Maternal and Child
Health Centre (MCHC). If we manage to persuade the managerial staff, we proceed to the final
stage in which a meeting will be arranged between the principal medical officer of the
department head and the senior medical officers. If the head office grants the proposed
innovation, resources and manpower will be allocated.
Communication with the frontline staff
A working team will be formed for the innovation, which consists of two nursing officers
and two registered nurses. With the permission from the department head, team members
organize an orientation program to explain the implementation details and the rationale of the
proposed innovation to the participating nurses. After the orientation program, two training
sessions will be arranged in two successive clinic meetings on Wednesdays and each session will
26
last for one hour. The training sessions will be conducted by a dietitian and a physiotherapist.
During the implementation period, the team members keep listening and discussing with the
frontline staff during regular weekly meetings. If difficulty is found, the team members can
refine the innovation through discussion with the frontline nurses. All these can help
implementing the innovation smoothly.
4.2 Pilot testing
A pilot study will be conducted before implementing the full-scale intervention. The
objective is to test the feasibility of the proposed intervention, to evaluate the outcome and to
observe the possibility of unexpected difficulties in real clinical setting. In addition, we also need
to assess the counseling skills of the participating nurses.
We expect the pilot study can recruit 20 eligible postpartum women. The participating
women are required to sign their consent forms before counseling. We expect the pilot study
lasts for eight weeks and the preparatory work requires two weeks. The evaluation and the
revision of the intervention are expected to take another two weeks. In summary, the pilot study
is expected to take three months.
Generally speaking, it is a new practice for nursing staff in MCHCs to counsel on the
method combining exercises and diet control. Therefore, it is necessary to have the nursing staff
participating the training program for the specific counseling skills which is led by a dietitian and
a physiotherapist. Eligible mothers will be selected and recruited from the group of mothers
during the postnatal visit at six week postpartum. The participating mothers will receive
counseling on the method combining exercises and diet control and are advised to conduct the
intervention at home. A weight loss booklet, a pedometer and a log book will be given to the
participating mothers for guidance, monitoring daily step counts, and recording daily step counts
27
with self-measured body weight respectively. During their visit for their 2-month-old baby
vaccination, the body weight of the mothers will be measured and follow-up counseling will be
given. Follow-up counseling by phone will be given at three month postpartum. If the mothers
encounter difficulty, positive feedback and support will be provided during follow-up counseling.
To monitor the implementation of the proposed intervention, the nursing officers of the
working team will evaluate the adequacy of the workflow and determine if the normal
functionality of the clinic is affected or not. The time spent for counseling each participating
mother will be recorded for evaluation purpose. The nursing officers will as well determine if the
materials, including pamphlets, weight log books and pedometers, are sufficient for the
intervention.
To evaluate the pilot study, we consider the competence of counseling skill, time
management and the knowledge of the staff. This is important to help maintaining the standard
of the proposed study. When the pilot test is over, the nursing staff will have an open discussion
with the team members. This allows sharing of their experience, reflecting the difficulties
encountered and suggestion for resolving the problems. This feedback is valuable for the team
members to make adjustment to the workflow and the intervention.
4.3 Evaluation Plan
The objective of the evaluation plan is to collect data for analysis. It helps assessing the
efficiency of the innovation and revealing possible improvement of the intervention.
Identification of Outcomes
The evaluation plan involves client and healthcare professional outcomes.
28
Client outcomes
The client outcomes is composed of two outcomes. One outcome is the weight loss at six
month postpartum of the participating mothers while the other outcome is the level of
satisfaction given by them.
The primary outcome of the innovation is the weight loss of the participating mothers at the
six month postpartum which are measured during the sixth month visit for the vaccination of
their infants. We expect there is a decrease of body weight at six month after the intervention. To
determine if the intervention is successful or not, we use a standard that if the women can reach a
weight loss of 5 percent or more of the baseline body weight, it is considered to be successful.
Magkos et al. (2016) reported that a weight loss of 5 percent is beneficial to health. Another
index of outcome is the level of satisfaction given by the mothers. This outcome is collected by
means of inviting the mothers to fill a questionnaire (Appendix H) at the six month visit. This
questionnaire generally reflects the effectiveness of the intervention and the performance of the
nurses.
Healthcare professional outcome
The healthcare professional outcome is collected through a self-report questionnaire
(Appendix I), distributed at the end of the implementation period, which ranks the level of
satisfaction of the program implementation and confidence level in the counseling.
Participants' eligibility
Eligible mothers are Chinese and are capable of reading and writing. They have undergone
vaginal deliveries and are nonsmoking with no illness. They come to MCHC for the six week
postnatal check up, having BMI 23-30 kg/m2 and are willing to reduce their body weight.
29
Sample size consideration
Considering a single proportion with significant level of 5% and power at 80%, we need at
least of 165 mothers for the intervention. As we predict there is a drop-out rate of 15%, we need
to recruit at least 195 mothers. There would be around 200 mothers coming to the designated
MCHC for postnatal checkup every month. Meanwhile, 40% of the mothers are overweight in
which around 80% of them meet the inclusion criteria and express the intention to join the
weight control program. Therefore, we expect that we can recruit 65 mothers each month and
three months would be sufficient to recruit 195 mothers for the intervention.
Measurement
The first measurement will be taken from the mothers at six week postnatal visit. The
measurement includes body weight and body height and the body mass index (BMI) will then be
computed. The participating mothers will receive individual counseling by nurses in private
interview rooms. After taking the baseline measurement at six week postpartum, we will provide
continuing support through telephone calls or face-to-face interviews in every month. Another
body weight measurement will be taken for the mothers at six month postpartum during
interview when their children come back to the MCHC for vaccination.
To measure the satisfaction of the participating mothers, they will be given a self-
administered questionnaire which includes questions concerning the attitude and skills of the
healthcare professionals, and possible improvement of the intervention (Appendix H). This
questionnaire will be distributed to the mothers during the 6 month child health visit.
We will also collect the information from the healthcare professionals including their
satisfaction with the program, arrangement of the intervention, their confidence level and
30
opinions for further improvement by means of a self-report questionnaire (Appendix I). This
measurement will be taken at the end of the implementation period.
Data Analysis
We will make use of the Statistical Package for the Social Sciences (SPSS) to analyze the
collected data. Our objective is to test if the participating mothers have a weight loss of 5 percent
or above comparing with their baseline body weight. We make use of the Chi-Square test to do
the analysis. To analyze the satisfaction of the participating mothers and the professionals, we
make use of one sample t-test method.
Basis of an Effective Change of Practice
We consider the proposed innovation is effective if 80% of the participating mothers can
reach a weight loss of at least 5 percent compared with the baseline at six month postpartum. For
the satisfaction of the participating mothers and the healthcare professionals, we consider the
proposed innovation is successful if at least 80 percent of the clients and the healthcare
professionals reporting the "strongly agree" or "agree" levels concerning the overall satisfaction.
31
Chapter 5: Conclusion
In conclusion, the reviewed studies provide strong evidences showing that the counseling
intervention combining diet control and exercises manage to facilitate body weight reduction for
overweight and obese postpartum women. The studies as well showed that the structured
individualized counseling is feasible and effective in MCHCs. In order to successfully carry out
the intervention, a clear evidence-based guideline was set up. Communication with the
stakeholders is also essential for continuous improvement of the intervention. Moreover, a
comprehensive evaluation is necessary for assessing the effectiveness of the program.
I
References
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Bertz F, Brekke HK, Ellegard L, Rasmssen KM, Wennergren M, Winkvist A (2012) Diet and exercise weight-loss trial in lactating overweight and obese women, American Journal of Clinical Nutrition 4, 698-705.
Colleran HL, Wideman L, Lovelady CA (2012) Effects of energy restriction and exercise on bone mineral density during lactation, Medicine & Science in Sports & Exercise 44(8) 1570-9.
Craigie AM, Macleod M, Barton KL, Treweek S, Anderson AS (2011) Supporting postpartum weight loss in women living in deprived communities: Design implications for a randomised control trial. European Journal of Clinical Nutrition 65(8), 952–8.
Crowell DT (1995) Weight change in postpartum period. A review of the literature, Journal of Nurse-Midwifery 40(5), 418–23.
Department of Health, Centre for Health Protection, 'Behavioural Risk Factor Survey-Body Mass Index (BMI) Distribution, April 2014' http://www.chp.gov.hk/tc/data/1/10/280/3994.html (assessed 15 Nov 2015).
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Gore SA, Brown DM, West DS (2003) The role of postpartum weight retention in obesity among women: a review of the evidence. Annals of Behavioral Medicine 26(2), 149–59.
Institute of Medicine (1990) Nutrition During Pregnancy. Washington, DC, National Academy Press.
Ko GT. (2008) The cost of obesity in Hong Kong, Obesity Review 9, 74-77.
Krummel DA (2007) Postpartum Weight Control: A Vicious Cycle. Journal of the American Dietetic Association 107(1), 37-40.
Linne Y, Barkeling B, Rossner S (2002) Long-term weight development after pregnancy. Obesity Reviews 3(2), 75–83.
Linne Y, Rossner S (2003) Interrelationship between weight development and weight retention in subsequent pregnancies: the SPAWN study, Acta Obstetricia et Gynecologica Scandinavica 82(4), 318–25.
Lovelady CA, Garner KE, Moreno KL, Williams JP (2000) The effect of weight loss in overweight, lactating women on the growth of their infants. New England Journal of Medicine 342(7), 449–53.
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Magkos F, Fraterrigo G, Yoshino J, Luecking C, Kirbach K, Kelly SC, De Las Fuentes L, He S, Okunade, AL, Patterson BW, Klein S (2016) Effects of moderate and subsequent progressive weight loss on metabolic function and adipose tissue biology in humans with obesity, Cell metabolism 23(4), 591-601.
McCrory MA, Nommsen-Rivers LA, Mole PA, Lonnerdal B, Dewey KG (1999) Randomized trial of the short-term effects of dieting compared with dieting plus aerobic exercise on lactation performance. American Journal of Clinical Nutrition 69(5), 959–67.
Mamun AA, Kinarivala M, Oʼcallaghan MJ, Williams GM, Najman JM, Callaway LK (2010) Associations of Excess Weight Gain During Pregnancy With Long-Term Maternal Overweight and Obesity: Evidence From 21-Year Postpartum Follow-Up, Obstetrical & Gynecological Survey, 65(9), 554-555.
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Melzer K, Schutz Y (2010) Pre-pregnancy and pregnancy predictors of obesity. International Journal of Obesity 34(S2), S44(9).
Mottola, MF (2009) Exercise Prescription for Overweight and Obese Women: Pregnancy and Postpartum. Obstetrics and Gynecology Clinics of North America 36(2), 301-316.
Norman E, Sherburn M, Osborne RH, Galea MP (2010) An exercise and education program improves well-being of new mothers: a randomized controlled trial. Physical Therapy 90(3), 348(8).
O’Toole ML, Sawicki MA, Artal R (2003) Structured diet and physical activity prevent postpartum weight retention. Journal of Women’s Health 12(10), 991–8.
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WHO/IASO/IOTF. (2000) The Asia-Pacific perspective: redefining obesity and its treatment. Health Communication Australia Pty Ltd.
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III
Appendix A - PRISMA Flow Diagram of Searches History
IV
Appendix B - Evidence Table
V
VI
VII
VIII
Appendix C - SIGN Appraisal Checklist
Citation 1: Craigie et al. (2011)
Study design: Randomized controlled trial
Internal validity
1.1 The study addresses an appropriate and clearly focused question.
Yes Population, intervention and outcomes were stated clearly in the method part.
1.2 The assignment of subjects to treatment groups is randomised.
Yes Participants were randomized to an intervention or comparison group using 1:1 random sampling procedure in SPSS.
1.3 An adequate concealment method is used.
Can't say No concealment method is reported.
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Yes Assessments were performed by a research assistant blinded to randomisation allocation
1.5 The treatment and control groups are similar at the start of the trial.
Yes No significant group differences of baseline characteristics were identified between intervention and comparison group.
1.6 The only difference between groups is the treatment under investigation.
Yes There was no important difference between treatment groups other than the treatment being studied.
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
31%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
No No intention to treat was used.
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Does not apply
Overall assessment of the study
2.1 How well was the study done to minimise bias? Code as follows:
Acceptable (+)
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
IX
Citation 2: Colleran et al. (2012)
Study design: Randomized controlled trial
Internal validity
1.1 The study addresses an appropriate and clearly focused question.
Yes
Population, intervention and outcomes were stated clearly in the method part.
1.2 The assignment of subjects to treatment groups is randomised.
Yes A computer-generated random numbers table was used to stratify primiparous and multiparous women into intervention group or control group
1.3 An adequate concealment method is used.
Yes
Group assignment was concealed in individual sealed envelopes by a third party not affiliated with the study.
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Can't say
Not mention the blinding of participants and investigators.
1.5 The treatment and control groups are similar at the start of the trial.
Yes No significant differences between groups were found.
1.6 The only difference between groups is the treatment under investigation.
Yes There was no important difference between treatment groups other than the treatment being studied.
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
12.9%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
No No intention to treat was used
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Does not apply
Overall assessment of the study 2.1 How well was the study done to minimise bias?
Code as follows: High quality (++)
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
X
Citation 3: Lovelady et al. (2000)
Study design: Randomized controlled trial
Internal validity
1.1 The study addresses an appropriate and clearly focused question.
Yes
Population, intervention and outcomes were stated clearly in the method part.
1.2 The assignment of subjects to treatment groups is randomised.
Yes Subjects were randomized with the use of a random-number table and randomization was stratified.
1.3 An adequate concealment method is used.
Can't say No concealment method is reported.
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Can't say
Not mention the blinding of participants and investigators.
1.5 The treatment and control groups are similar at the start of the trial.
Yes No significant differences between groups were found.
1.6 The only difference between groups is the treatment under investigation.
Yes There was no important difference between treatment groups other than the treatment being studied.
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
16.7%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
No No intention to treat was used.
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Does not apply
Overall assessment of the study
2.1 How well was the study done to minimise bias? Code as follows:
Acceptable (+)
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
XI
Citation 4: O'Toole et al. (2003)
Study design: Randomized controlled trial
Internal validity
1.1 The study addresses an appropriate and clearly focused question.
Yes
Population, intervention and outcomes were stated clearly in the method part.
1.2 The assignment of subjects to treatment groups is randomised.
Can't say Randomization stated but method not reported.
1.3 An adequate concealment method is used.
Yes Allocation was used by means of blinded drawing labels containing group assignment.
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Can't say
Not mention the blinding of participants and investigators.
1.5 The treatment and control groups are similar at the start of the trial.
Yes No significant differences between groups were found.
1.6 The only difference between groups is the treatment under investigation.
Yes There was no important difference between treatment groups other than the treatment being studied.
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
42.5%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
No No intention to treat was used
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Does not apply
Overall assessment of the study
2.1 How well was the study done to minimise bias? Code as follows:
Acceptable (+)
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
XII
Citation 5: McCrory et al. (1999)
Study design: Randomized controlled trial
Internal validity
1.1 The study addresses an appropriate and clearly focused question.
Yes
Population, intervention and outcomes were stated clearly in the method part.
1.2 The assignment of subjects to treatment groups is randomised.
Yes Subjects were randomized based on computer with variable block size.
1.3 An adequate concealment method is used.
Can't say No concealment method is reported.
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Can't say
Not mention the blinding of participants and investigators.
1.5 The treatment and control groups are similar at the start of the trial.
Yes No significant differences between groups were found.
1.6 The only difference between groups is the treatment under investigation.
Yes There was no important difference between treatment groups other than the treatment being studied.
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
2.94%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
No No intention to treat was used
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Does not apply
Overall assessment of the study
2.1 How well was the study done to minimise bias? Code as follows:
Acceptable (+)
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
XIII
Citation 6: Bertz et al. (2012)
Study design: Randomized controlled trial
Internal validity
1.1 The study addresses an appropriate and clearly focused question.
Yes
Population, intervention and outcomes were stated clearly in the method part.
1.2 The assignment of subjects to treatment groups is randomised.
Yes Subjects were randomized in blocks and randomization was stratified.
1.3 An adequate concealment method is used.
Can't say Concealment was mentioned but no detail was provided
1.4 The design keeps subjezcts and investigators ‘blind’ about treatment allocation.
Can't say
Not mention the blinding of participants and investigators.
1.5 The treatment and control groups are similar at the start of the trial.
Yes No significant differences between groups were found.
1.6 The only difference between groups is the treatment under investigation.
Yes There was no important difference between treatment groups other than the treatment being studied.
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
16.2%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
No No intention to treat was used
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Does not apply
Overall assessment of the study 2.1 How well was the study done to minimise bias?
Code as follows: Acceptable (+)
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
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Appendix D - Timelines for the program
Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Preparation & staff training
Pilot study Implementation Data collection Evaluation
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Appendix E - Estimated material and non-material costs of the innovation
Estimated material costs for every 48 clients per month X 3 months = 144 targets
Materials Cost Pamphlets and leaflets $2000 Log book $1000 Pedometer $3000 Total $6000
Estimated non-material costs for implementation of 3 months innovation
Materials Details Cost/Hr Cost Diet control counseling training
One Dietitian for the training
$300 2 hours x $300= $600
Exercise counseling training One Physiotherapist for the training
$300 2 hours x $300 = $600
Individual counseling on diet control and exercise
Done by registered nurses
$200 30mins x 144 / 60 mins =72 hours --> $200 x 72 = $14,400
Follow up sessions (by interview and telephone)
Done by registered nurses
$200 15 mins x 5 x 144 / 60mins=180 hours --> $200 x 180= $36,000
Evaluation of the intervention Data analysis and entry
$200 15 mins x 144 / 60mins=36 hours --> $200 x 36 = $7200
Total $58,800
The total costs for the innovation = $6,000 + $58,800 = $64,800
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Appendix F - Evidence-based practice guideline
Individualized counseling on diet control and exercises to prevent obesity among postpartum women.
Purpose
To assist postpartum women who are overweight or obese to control the weight through diet control and exercises.
Objectives
1. To summarize the clinical evidence and formulate the evidence based guideline to support postpartum women who are overweight or obese for weight reduction by means of individual counseling and support in the first 6 months of the postpartum period.
2. To increase the awareness of healthy lifestyle.
3. To reduce the risk of developing various chronic diseases in long term.
Target population
The target population is postpartum women who are with BMI ranging from 23 to 30 kg/m2, vaginal deliveries, nonsmoking, with no illness, hoping to have weight reduction and going to attend postnatal check up service in the sixth week of the postpartum period.
Major Outcomes
At least 5% of body weight reduction during the six-month postpartum period.
Interventions and Practices
The intervention comprises the individual counseling and support including face-to-face interviews and follow up in clinic or through phone, pamphlets, leaflets and log book.
Recommendation of the Clinical Guideline
Recommendation 1
The counseling of the combined method of diet control and exercises can be done by nurses who have received the training. (Grade A)
Mothers of the intervention group receive the intervention provided by a trained lifestyle counselor through consultation. (Craigie, et al., 2011) (1+)
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Recommendation 2
It should be best to provide individual counseling for each participant. (Grade A)
Participants were provided with face-to-face consultations and personalised dietary prescription.
(Craigie, et al., 2011) (1+) (Colleran, et al., 2012) (1++) (Lovelady, et al., 2000) (1+) (McCrory
et al., 1999) (1+) (Bertz, et al., 2012) (1+) (O'Toole et al., 2003) (1+)
Recommendation 3
Energy requirement for each participant will be calculated individually by using the equation
from Food and Nutrition Institute of Medicine (IOM) (2005). An additional 330kcal is added for
breastfeeding mothers. Then, 500kcal was subtracted with minimum dietary prescription of
1800kcal. A weight loss booklet will be issued with guidance on food groups, frequency of
consumption and portion size. (Grade A)
Energy needs were calculated using the total energy expenditure equation from the Dietary
Reference Intakes for overweight, nonpregnant, nolactating women (IOM, 2005). An additional
330 kcal was added for breastfeeding and then 500 kcal was subtracted to facilitate a weight loss
of 1lb/wk. The minimum energy intake prescribed was 1800kcal. (Colleran, et al., 2012) (1++)
The weight loss booklet was issued with written guidance on food groups, frequency of
consumption and portion size. (Craigie, et al., 2011) (1+)
Recommendation 4
The exercise program will include walking 10,000 steps or 3000 aerobic steps per day at least 5
days/week. For the plan of walking 10,000 steps/day, each participant can start with at least 4000
steps per day and increase the daily step count by 100 to 200 steps per day during first 4-6 weeks
until the goal of 10,000 steps per day is reached. The 10,000 steps could include walking with
the baby in a carriage. A pedometer will be issued to each participant. A log book will be given
to record the exercise sessions, step counts and self-monitoring for weight. (Grade A)
The exercise protocol consisted of 10,000 steps or 3000 aerobic steps per day at least 5
days/week. Each participant started with a minimum of 4000 steps per day and was instructed to
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increase their daily step count by 100 to 200 steps per day during the first 4-6 weeks until the
goal of 10,000 steps per day was reached. An alternate option of 'reaching 3000 aerobic steps'
was offered to participants with 3000 aerobic steps are equivalent to walking 30 min at a brisk
pace. All exercise sessions were recorded in a logbook to assess compliance to the protocol.
(Colleran, et al., 2012) (1++)
A weight log book was given to each participant for self-monitoring. (Craigie, et al., 2011) (1+)
Walks were done with the baby in a carriage. (Bertz, et al., 2012) (1+)
Recommendation 5
Regular follow up sessions and phone follow up should be held at around 1 month intervals to
identify participants' progress, achievements and challenges and to give positive feedback and
support. Participants could come back for follow up sessions during their babies receiving
vaccines at second, fourth and sixth month of age. Phone follow up will be done in between
visits or if the mother did not turn up during their babies' vaccination. They are encouraged to
call back if they have any enquiry.
Participants were allocated three face-to-face consultations at monthly intervals. Between
consultations, contact was maintained by the lifestyle counselor via a minimum of three
structured phone calls to identify progress towards goals, achievements and challenges and to
provide positive feedback and support. (Craigie, et al., 2011) (1+)
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Appendix G - SIGN Grading System Levels of Evidence and Grades of Recommendation
Levels of evidence
1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1 - Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort or studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal
2 - Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
Grades of recommendation
A At least one meta analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results
B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+
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Appendix H - Questionnaire ( For Mothers only)
Please choose the appropriate answer
Strongly agree
Agree Disagree Strongly disagree
1. The program is beneficial to you.
2. The counseling time is sufficient.
3. There is adequate follow-up in the program.
4. The counseling environment is comfortable with adequate privacy.
5. The health care professionals are knowledgeable regarding weight control.
6. The healthcare professionals are supportive and helpful.
7. The pamphlets of the program are informative.
8. The pedometer can help in monitoring your step counts.
9. The log book can help in self monitoring step counts and body weight.
10. Overall, you are satisfied with this program.
Any other opinion on this program?
______________________________________________________________________________
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Appendix I - Questionnaire ( For Nursing staff only)
Please choose the appropriate answer
Strongly agree
Agree Disagree Strongly disagree
1. There is enough training for nursing staff before carrying out the program.
2. The program is suitable for the participating mothers.
3. The counseling time for the clients is adequate.
4. Follow-up for the clients is enough.
5. You feel confident in providing counseling to the clients.
6. The workload is affordable.
7. Overall, you are satisfied with this program.
Any other opinion on this program?
______________________________________________________________________________