1. Preventing Childhood Obesity Starting Early: The Baby Milk Trial Raj Lakshman MRC Epidemiology Unit 24 th January 2012

2. Outline Infant feeding in obesity prevention The Baby Milk Trial -Rationale -Development -Design -Outcomes -Policy implications

3. Over 1 in 5 children overweight (13%) or obese (10%) NCMP 2009/10 Early intervention is a National priority Foresight, HWHL Evidence of programming -Appetite -Flavour -Metabolic Why infant feeding is important?

4. 6 kg in 1 st year

5. Distance between 2 lines 0.67SDS

6. Druet et al 2011 Paediatric and Perinatal Epidemiology 2 fold higher risk

8. Ekelund et al 2006 AJCN Leunissen et al 2009 JAMA Crossing 1 centile line (0.67 SDS) from 0-6 mo Fat mass at 17yrs

9. FAO/WHO/UNU 2005, SACN 2011 40% in first weeks

10. FAO/WHO/UNU 2005

11. Ong et al 2002 Paediatric Research Age in years Weight SDS

12. Breast feeding statistics (UK) 81% start BUT by 6 weeks only 21% exclusively breastfeeding

13. How we designed the intervention and evaluation Campbell et al 2007 BMJ Framework for complex interventions Determinants Systematic Reviews Qualitative studies Questionnaires Multi-disciplinary team

14. Aim: to understand determinants of non-recommended feeding practices 78 studies, 48 determinants Early Weaning- young maternal age, low education, low SES, smoking, short breastfeeding, lack of information and advice from Healthcare providers JADA 2010

15. Aim: how parents decide on how much and how often to feed their babies? 23 studies No literature on this Inadequate information and support Negative emotions- guilt, worry, sense of failure Mistakes in feed preparation Frequent formula-feed changes

17. In Press: Lakshman R, Landsbaugh J, Schiff A, Cohn C, Griffin S, Ong KK Interviews, Focus groups Mothers, Healthcare providers ‘I had no advice on bottle feeding and he was crying so much that I was feeding him every ten minutes…..’ ‘He drank for six and a half hours and he was swallowing for six and a half hours. He would drink about two and a half bottles. …..sometimes he’d have nine bottles a day.’

18. 57-item questionnaire Energy intake Maternal attitudes Face validity, Criterion validity, Test-retest reliability Almost half the mothers who prepared formula-milk from powder, tightly packed the scoops IJBNPA 2011

19. What is the Baby Milk intervention? Optimise energy intake Infant satiety cues Non-hunger related fussiness Feedback on growth Rapid weight gain Weaning

20. The components of the Baby Milk intervention Coping Planning Motivation Action Planning Communication skills Techniques I intend to follow the Baby Milk Feeding Guidelines This is how I plan to put the Baby Milk Feeding Guidelines into action This is how I will stick to the Baby Milk Feeding Guidelines when the going gets tough

21. Baby Milk Trial Explanatory RCT to examine efficacy of the Baby Milk intervention Primary Outcome change in weight sds from birth-1yr Trial and cohort analyses

22. 700 Mothers who start formula feeds within 14 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

23. Behavioural Determinants Behaviour Growth Health/Disease Outcomes 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

24. 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 I- Intervention, C- Control group

25. Policy implications Inform future infant feeding guidelines Health Visitor practice and Healthy Child Programme NPRI Scientific Committee ‘A powerful intervention that has potential to provide valuable evidence in an important and changing policy environment’

26. Thank You CEDAR support Rebecca StraffordResearch Manager, CEDAR Annie Schiff Study Co-ordinator, CEDAR Alvaro UllrichData Manager, CEDAR Intervention FacilitatorsPaediatric Research Nurses, University of Cambridge MRC Epidemiology Unit support James SylvesterResearch Manager, MRC Measurement TeamResearch Assistants, MRC Investigators Ken OngProgramme Leader, MRC Simon GriffinAssistant Director, MRC Wendy HardemanSenior Research Associate, IPH Simon CohnSenior Lecturer, IPH Marc SuhrckeProf Health Economics, UEA Ed WilsonLecturer Health Economics, UEA Collaborators David VickersMedical Director, CCS NHS Trust Alison LennoxPrincipal Investigator Scientist, MRC HNR

27. ACKNOWLEDGEMENT 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.