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Establishing a healthy growth trajectory from birth The Baby Milk Trial 14 th February 2011 Institute of Public Health, Cambridge. Why intervene early?. Over 1 in 5 children in England are already overweight (13%) or obese (10%) when they start school
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Establishing a healthy growth trajectory from birth The Baby Milk Trial 14th February 2011 Institute of Public Health, Cambridge
Why intervene early? • Over 1 in 5 children in England are already overweight (13%) or obese (10%) when they start school • Early intervention is a National priority • Evidence of ‘programming effect’ • Appetite • Metabolic
Why intervene early? • Infancy is a period of rapid growth, hence obesity prevention may be most effective • Recent systematic reviews have shown that rapid weight gain during infancy is associated with later obesity Ong Acta Paediatrica 2006 • Energy deposition as %TER-40% at 1 month, 1-2% at 1yr WHO/FAO/UNU Report
Why intervene early? • Rapid weight gain in infancy predicts fat mass in young adults Ekelund U et al 2006 AJCN • Rapid (>0.67 SDS) weight gain in the first 3 months associated with several determinants of CVD and type 2 diabetes in adults Leunissen R et al 2009 JAMA • Childhood BMI is related to CHD in adulthood Baker J el al 2007 NEJM
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
What is the Baby Milk Trial? • Explanatory RCT to examine the feasibility, acceptability and efficacy of the Baby Milk intervention - Prevent excess weight gain during infancy - Reduce formula milk intake • Understand the underlying psychological mediators
Trial Design Intervention group • 3 face-to-face contacts • 2 telephone contacts Control group • Same number of contacts Primary outcome • Difference in weight sds • % rapid weight gain
Measurements Behavioural Determinants Attitudes, beliefs, intentions, self-efficacy, outcome-expectancy- Questionnaires at baseline and 6-months Behaviour Milk feeding – questionnaire at baseline, 3,4, 5, 6 months, Diet diary at 8 months Socioeconomic, cultural, antenatal and genetic factors Anthropometry at baseline, 6 and 12 months, USS and skin-folds at 12 months Growth Link to National Child Measurement Programme, modelling long term outcomes, cost-effectiveness analyses, long term follow-up, Health/disease outcomes
The Baby Milk Team and collaborators Intervention Facilitators Anne-Marie Wardell Karen Forbes Suzanne Smith With help from Annie Schiff Wendy Hardeman Study Management Annie Schiff Alvaro Ullrich With help from James Sylvester Nick Barker Anthony Wright 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 Measurement Team Esther Fakeye Richard Powell Ruth Watson With help from Ema De Lucia Rolfe
Any questions? Thank you for your time