title: Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: the baby milk intervention and trial.
abstract: BACKGROUND
  We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours.
  
  
  METHODS
  We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects.
  
  
  CONCLUSIONS
  In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.
authors.affiliation: MRC Epidemiology Unit, University of Cambridge, Addenbrooke's Hospital, P.O. Box 285, Cambridge CB2 0QQ, UK ; UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge CB2 0QQ, UK.
authors.forename: Rajalakshmi
authors.identifier: 0000-0001-6748-5960
authors.initials: R
authors.lastname: Lakshman
authors.affiliation: MRC Epidemiology Unit, University of Cambridge, Addenbrooke's Hospital, P.O. Box 285, Cambridge CB2 0QQ, UK ; UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge CB2 0QQ, UK ; The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge CB2 0SR, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Griffin
authors.affiliation: The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge CB2 0SR, UK.
authors.forename: Wendy
authors.initials: W
authors.lastname: Hardeman
authors.affiliation: UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge CB2 0QQ, UK.
authors.forename: Annie
authors.identifier: 0000-0002-6745-9954
authors.initials: A
authors.lastname: Schiff
authors.affiliation: The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge CB2 0SR, UK.
authors.forename: Ann Louise
authors.initials: AL
authors.lastname: Kinmonth
authors.affiliation: MRC Epidemiology Unit, University of Cambridge, Addenbrooke's Hospital, P.O. Box 285, Cambridge CB2 0QQ, UK ; Department of Paediatrics, University of Cambridge, Cambridge CB2 0QQ, UK.
authors.forename: Ken K
authors.initials: KK
authors.lastname: Ong
mesh_terms: D000328:Adult; D035843:Biomedical Research; D005240:Feasibility Studies; D005247:Feeding Behavior / Q000523:psychology*; D005260:Female; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D008297:Male; D009035:Mothers / Q000523:psychology; D016487:Parenting; D063766:Pediatric Obesity / Q000517:prevention & control* / Q000523:psychology; D011247:Pregnancy; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires; D015430:Weight Gain