NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”

University of Oxford Examination Schools

Monday 9 and Tuesday 10 December 2013

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”

Parallel Session B Healthy lifestyle in pregnancy

and childhood

14.10-15.25

Chaired by Amanda Daley

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”

Recruiting to a trial of an infant

feeding intervention: Lessons

from the Baby Milk Trial

Fiona Whittle

Recruiting to a trial of an infant feeding intervention:

Lessons from the Baby Milk Trial

Fiona Whittle

MRC Epidemiology Unit

9th December 2013

Aims of the study

• Explanatory RCT to examine the feasibility, acceptability and efficacy of the Baby Milk intervention

- Reduce formula milk intake

- Prevent excess weight gain

during infancy

• Understand the underlying psychological mediators of infant feeding behaviour

Target population

• Bottle (or mixed) fed babies

• Less than 14 weeks old

• Healthy babies, growing normally

No major malformations, hormonal or metabolic diseases which

might interfere with nutrition or growth

• No special or prescribed formula (i.e. soya-based,

lactose-free, hydrolysed or anti-reflux formulas)

Why formula fed babies?

• Formula fed babies grow faster

• Evidence suggests that rapid weight gain in our early years predicts fat mass in young adults Ekelund U et al 2006 AJCN

• 2004 FAO/WHO/UNU

recommendations 15-20% lower than 1985

• Bottle fed babies are more likely to be overfed

Age (years)

Ong et al 2002 Paed Research

Aims of the Baby Milk intervention

Multi component theory based intervention to: • Reduce energy intake

• Help mothers recognise when babies are full

• Recognise that babies cry for reasons other than hunger

• Recognise Rapid weight gain

• Delayed and healthy weaning

Screening

Participant Identification Mothers who started formula feeds within 14 weeks of birth

Baseline visit - CONSENTED

Intervention group

Baby’s age 6-7 months-End of intervention

Baby’s age 8 months- 4 Day-Diet Diary

Baby’s age 12 months-Outcome measurements

Control group

Behavioural intervention Standard advice

2 mo

3 mo

4 mo

5 mo

6 mo

5 mo

4 mo

3 mo

2 mo

6 mo

Participant Identification

Multi-method approach:

• Health visitors

• GPs (6 week check)

• Children’s Centres

• Other: Media, posters, word of mouth

• Postnatal ward (research staff)

• Community Midwives

• Systm1 database mail out

Recruitment timeline

Recruitment via Health Visitors,

GPs, and publicity

Systm1 Mail out

Approach at 0 weeks on ward

Where our participants were identified:

Variation in success

Against the clock: Converting positive responses to recruitment

Patient Identification Source Positive

replies (N) Recruited

(N) Conversion rate (%)

Postnatal ward 627 109 17

Community Midwives 17 4 24

GPs (20 Practices) 420 122 29

Systm1 mail out 160 97 61

Health visitors 8 6 75

Other (posters, media, word of mouth) 29 24 83

Positive replies Recruited Conversion rate (%)

GP Practice 1 23 7 30

GP Practice 2 22 3 14

Other factors to consider

• New-born – lots going on – when is ideal time – 6week vs.

2week

• Formula-fed are a harder to reach group

I’m interested, but with 2 toddlers and this little one I just don’t have the time

We’ve just got in a routine and he’s

happy, I don’t want to have to change

anything

33% of participants request a home visit

• Restructuring of Community Health Visiting

• Attitudes to studies in Formula-fed infants (“Breast is best”)

• Time-pressures of infancy

• Hard to reach group

Challenges

Successes

• Access to routine databases & NHS-network support

• Motivating GP practices

- PCRN Research Site Initiative (RSI)

- Regular feedback

• Support by local NHS Postnatal ward

• Active monitoring & openness to change

Thank You

The Scientists Raj Lakshman-MRC HSHP Fellowship

Ken Ong-Programme Leader, MRC

Simon Griffin-Assistant Director, MRC

Wendy Hardeman-Senior Research Associate, PHPC

Simon Cohn–Senior Lecturer, IPH

Marc Suhrcke-Prof Health Economics, UEA

Ed Wilson-Lecturer Health Economics, UEA

Intervention Facilitators Anne-Marie Wardell

Karen Forbes

Karen Poloka

Elizabeth White

Suzanne Smith With help from

Annie Schiff

Wendy Hardeman

Measurement Team Thomas Clare

Esther Fakeye

Charlotte Hewitson

Richard Powell

Christine May-Hall With help from

Ema De Lucia Rolfe

Study Management Fiona Whittle

Gisela Baker With help from

James Sylvester

Trevor Bunch

Susie Boatman

ACKNOWLEDGEMENTS The development and piloting work was undertaken by the Centre for Diet and Activity Research (CEDAR), a UKCRC Public Health Research Centre of Excellence. Funding from the British Heart Foundation, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. The trial is supported by the Department of Health and is funded by the National Prevention Research Initiative (http://www.npri.org.uk). The Funding Partners relevant to this award are (in alphabetical order): Alzheimer's Research Trust; Alzheimer's Society; Biotechnology and Biological Sciences Research Council; British Heart Foundation; Cancer Research UK; Chief Scientist Office, Scottish Government Health Directorate; Department of Health; Diabetes UK; Economic and Social Research Council; Health and Social Care Research and Development Division of the Public Health Agency (HSC R&D Division); Medical Research Council; The Stroke Association; Wellcome Trust; Welsh Assembly Government; and World Cancer Research Fund.

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”