1. The Baby Milk Trial Establishing a healthy growth trajectory from birth 12 th Ocober 2011 UEA Health Economics Workshop The Baby Milk Study Team

2. What is the Baby Milk Trial? Explanatory RCT to examine efficacy of the Baby Milk intervention Primary Outcome change in weight sds from birth-1yr

3. Mothers who start formula feeds within 12 weeks of birth Baseline visit at 2-14weeks 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 interventionStandard advice 2 mo 3 mo 4 mo 5 mo 6 mo 5 mo 4 mo 3 mo 2 mo 6 mo

4. What are the components of the Baby Milk intervention?

5. Over 1 in 5 children in England are already overweight (13%) or obese (10%) when they start school NCMP 2009/10 Early intervention is a National priority Foresight, HWHL Evidence of ‘programming effect’ - Appetite - Flavour - Metabolic Why intervene early?

6. Infancy is a period of rapid growth hence obesity prevention may be most effective Rapid weight gain during infancy is associated with later obesity Druet et al 2011 Rapid weight gain in infancy predicts fat mass in young adults Ekelund U et al 2006 AJCN

7. Why the Baby Milk intervention? Faster infant weight gain leads to childhood overweight and obesity Bottle-fed infants grow faster than breastfed and become more overweight Among bottle-fed infants, more milk leads to faster weight gain and higher childhood BMI

8. Why the Baby Milk intervention? 1985 recommendations based on ‘energy intake’ using ‘indirect calorimetry’ 2001 recommendations based on ‘energy expenditure’ using ‘doubly labelled water’ Previous recommendations overestimated energy requirements by 15-20% Formula fed babies likely to be overfed

9. Behavioural Determinants Behaviour Growth Health/Disease Outcomes Link to National Child Measurement Programme, modelling long term outcomes, cost-effectiveness analyses, long term follow-up Anthropometry at baseline, 6 and 12 months, USS and skin-folds at 12 months Milk feeding – questionnaire at baseline, 3,4, 5, 6 months, Diet diary at 8 months Attitudes, beliefs, intentions, self-efficacy, outcome-expectancy- Questionnaires at baseline and 6-months Socio-economic, cultural, antenatal and genetic factors Evaluation: Causal modelling

10. Baseline Questionnaire measures Pregnancy, Demography, Lifestyle etcI,C Milk feeds (also at 3,4,5 mo)I,C Feeding and maternal attitudesI,C Temperament, sleep, eating behaviourI,C 4-day diet diary Health service utilisation Maternal QoLI,C Intervention evaluation Anthropometry Parents’ anthropometryI,C Baby’s anthropometryI,C 6 mo I,C I 8 mo I,C 12 mo I,C I Study Measures

11. This 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. ACKNOWLEDGEMENT

12. Thank you for listening Any questions? Website: http://www.mrc-epid.cam.ac.uk/Research/Studies/BabyMilk/index.html Email: babymilkstudy@epid.cam.ac.uk Phone:08007560878