title: Qualitative findings from an exploratory trial of the Healthy Lifestyles Programme (HeLP) and their implications for the process evaluation in the definitive trial.
abstract: BACKGROUND
  Approximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required. However, despite the increasing number of school-based interventions to prevent obesity, results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status. The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours.
  
  
  METHODS
  A process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of; the trial design (including the trial outcomes) and the HeLP Programme and whether it is able to engage schools, children and their families. Data was collected using interviews with teachers (n = 12) and parents (n = 17) and six focus groups with children (n = 47) and a questionnaire for parents of children in the intervention schools. Interview and focus group data relating to the intervention was analysed using framework analysis.
  
  
  RESULTS
  Four schools and 201 children participated in the exploratory trial. The data showed that the trial design was feasible and acceptable for schools and children. Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme (value, compatibility with the curriculum and enjoyment) and two themes emerged in relation to engagement ('knowledge and awareness' and 'taking messages on board'). The latter could be broken down into 4 subthemes ('initiating discussion with family and friends', 'acceptance of family rules', 'increased responsibility' and 'the importance of the mode and agent of delivery'). The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with and take ownership of the healthy lifestyle messages were identified as important factors in motivating the children to take the messages home, seek parental support and initiate family lifestyle behaviour change.
  
  
  CONCLUSIONS
  The process evaluation of the exploratory trial has not only provided evidence of the feasibility and acceptability of the Programme, it has also allowed an understanding of how HeLP engages schools, children and their families. These findings have informed the process evaluation for the definitive trial.
authors.affiliation: Institute for Health Research, University of Exeter Medical School, University of Exeter, Exeter, UK. J.J.Lloyd@exeter.ac.uk.
authors.forename: Jenny J
authors.initials: JJ
authors.lastname: Lloyd
authors.forename: Katrina M
authors.initials: KM
authors.lastname: Wyatt
mesh_terms: D000328:Adult; D002648:Child; D004739:England; D005260:Female; D017144:Focus Groups; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D063766:Pediatric Obesity / Q000517:prevention & control*; D017064:Process Assessment, Health Care; D012572:School Health Services; D011795:Surveys and Questionnaires