improving women's diet quality preconceptionally and during gestation: effects on birth weight...

Improving women’s diet quality preconceptionally and during gestation: effects on birth weight and prevalence of low birth weight—a randomized controlled efficacy trial in

India (Mumbai Maternal Nutrition Project)

Sirazul A Sahariah1, Ramesh D Potdar,1Meera Gandhi1, Monika Dayama1, Nick Brown2, Harshad Sane1, Patsy J Coakley3, Ella Marley-Zagar3, Harsha Chopra1, Sarah Kehoe3, Devi Shivshankaran1,

Vanessa A Cox3, Vijaya Taskar4, Barrie M Margetts5, Caroline HD Fall3

1Centre for Study of Social Change, Mumbai, India; 2Salisbury District Hospital, UK; 3MRC Lifecourse Epidemiology Unit, University of Southampton, UK; 4Streehitkarini, Mumbai, India;

5Public Health Nutrition, University of Southampton, UK

nehawww.controlled-trials.com ISRCTN62811278

Background:• Low birth weight (LBW) is common in undernourished

populations in low- and middle-income countries • One third of Indian babies are born under weight.• LBW is associated with increased perinatal mortality and

childhood stunting, poorer childhood cognitive function predominantly because of intrauterine growth restriction.

• It is also associated high risk of adult diseases. (high BP, Heart disease, Diabetes and other chronic diseases)

• The Pune Maternal Nutrition Study (PMNS)– Mothers who had higher intakes of green leafy vegetables,

fruit and milk had babies which were larger in all body measurements at birth.*

*Rao S et al. (2001) Intake of micronutrient-rich foods in rural Indian mothers is associated with the size of their babies at birth. Pune Maternal Nutrition Study. J. Nutr. 131: 1217–1224.

The intervention• Objective: To test whether improving women’s dietary micronutrient

quality before conception and throughout pregnancy increases birth weight in a high-risk Indian population.

• We aimed to improve diet quality rather than specific nutrient intakes by raising intakes of green leafy vegetables, fruit, and milk.

• The intervention was a daily snack made from green leafy vegetables, fruit and milk, provided for at least three months prior to conception and throughout pregnancy.

• We created a snack that, when taken 3 d/wk in addition to the usual diet, increased women’s average intakes of green leafy vegetables, fruit, and milk above the highest quartile in the Pune study

• On average, treatment snacks contained 10–23% of the WHO/FAO recommended Reference Nutrient Intakes for β-carotene, riboflavin, folate, vitamin B-12, calcium, and iron.

Methods• Period: Jan 2006 to June 2012• Study settings: Slum areas of Mumbai. • Participants: Married non-pregnant

women aged < 40 years, who had not completed their family.

• Community consent• Eligible participant were recruited

following written informed consent– Basic data and anthropometry – FFQ including physical activity– ID photograph

• Participants were randomised (by age and BMI)

Methods• Freshly prepared supplements were

transported to 61 centres daily between 3 – 6 PM. (110 recepies developed)

• Women received supplement under supervision and recorded.

• Women who became pregnant were followed three times during pregnancy.

• Babies were measured within 72 hours of birth in hospital or at home.

TOTAL WOMEN RECRUITEDN=6513

RANDOMIZED TO TREATMENT GROUP

N = 3205

RANDOMIZED TO CONTROL GROUP

N = 3308

PREGNANCIESFOLLOWED UP

N = 1106

PREGNANCIESFOLLOWED UP

N = 1185

STARTED SUPPLEMENT >90 DAYS BEFORE LMP DATE

N=857

STARTED SUPPLEMENT <90 DAYS BEFORE LMP DATE

N=249

STARTED SUPPLEMENT >90 DAYS BEFORE LMP DATE

N=969

STARTED SUPPLEMENT <90 DAYS BEFORE LMP DATE

N=216

SINGLETON LIVENEWBORNS WITHOUT MAJOR CONGENITAL ABNORMALITIES

N=736


N=221


N=826


N=179

Natural abortion 17Termination 11Twin pregnancy 2Single stillbirth/IUD 5Major abnormality 1Maternal death 0Unknown outcome 3

Not measured 75Measured >10 days 2

NEWBORNANTHROPOMETRY

N=518


N=144


N=576


N=122

Natural abortion 60Termination 47Twin pregnancy 10Single stillbirth/IUD 10Major abnormality 6Maternal death 3Unknown outcome 8

Natural abortion 48Termination 39Twin pregnancy 13Single stillbirth/IUD 15Major abnormality 4 Maternal death 0Unknown outcome 5

Natural abortion 9Termination 10Twin pregnancy 1Single stillbirth/IUD 1Major abnormality1 Maternal death 0Unknown outcome 6

STAYED IN THE STUDY BUT NEVER BECAME PREGNANT 755DROPPED OUT OF THE STUDY BEFORE BECOMING PREGNANT 1108BECAME PREGNANT TOO EARLYEXCLUDED AND NOT FOLLOWED FURTHER 160

STAYED IN THE STUDY BUT NEVER BECAME PREGNANT 692DROPPED OUT OF THE STUDY BEFORE BECOMING PREGNANT 1135

BECAME PREGNANT TOO EARLYEXCLUDED AND NOT FOLLOWED FURTHER 272




2291

1826

1562

1094

CONSORT DIAGRAM

Results • LBW: 34% vs. 41%; OR: 0.76; 95% CI: 0.59, 0.98 (P = 0.03) : 24% • Small-for-gestational-age: 66% vs. 71%; OR: 0.80; 95% CI: 0.61, 1.04 (P =0.09) : 20% • No change in….

• Large-for-gestational-age infants (0.6% vs. 0.5%; P = 1.0)• Preterms (12.7% vs. 12.3%; P = 0.87)

The prevalence of GDM (WHO 1999 criteria): 9.9%. • 7.5% vs. 13.1%, P = 0.01; OR: 0.54; 95% CI: 0.33, 0.86)

Birt

h w

eigh

t (g)

ALL WOMEN

CONTROL

TREATMENT

Mother’s pre-pregnant BMI (kg/m2)

<18.6 18.6-21.8 >21.8

+ 48g - 7g + 79g + 113g

Mean and 95% confidence intervals

p=0.05 p=0.84 p=0.07 p=0.008

p for interaction=0.001

Scaling-up

• Intervention is scalable – Ways to make GLV, fruits available (rural Maharashtra)

• Barriers to fruit and vegetable consumption • Barriers to production and supply of fruit and vegetables

– Teach women to cook (individual or with self help group)

– Using social enterprise (Integration of maternal health with non-communicable disease surveillance)

– Commercial food companies

Summary

• There was modest increase in birthweight (48gms)

• Higher effect on women with high BMI (113 gms)

• Reduction of LBW (24%) and SGA (20%)• Reduction of GDM by 46%• Possibility of scaling up needs more study.

Acknowledgement• Study participants an their families• Collaborators:

– SNEHA India.– JJ and Nair Hospital, Mumbai – KEM Hospital Pune – Dr Dharap’s Lab Mumbai– Dr Joshi’s Imaging Clinic, Mumbai– Municipal Corporation of Greater Mumbai

• Funders: – ICCHN and ICICI Foundation – The Wellcome Trust – DFID, UK– Medical Research Council, UK, – Parthenon Trust, Switzerland.

The study is published and available free on lineAm J Clin Nutr doi: 10.3945/ajcn.114.084921. Thank You !

improving women's diet quality preconceptionally and during gestation: effects on birth weight...

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