title: A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods.
abstract: BACKGROUND
  Physical inactivity and a poor diet predict lifestyle diseases such as diabetes, cardiovascular disease, and certain types of cancer. Marked declines in physical activity occur during late adolescence, coinciding with the point at which many young people leave school and enter the workforce and begin to take greater control over their lifestyle behaviours. The work outlined within this paper sought to test a theoretically-informed intervention aimed at supporting increased engagement in physical activity and healthy eating habits in young people at the point of transition from school to work or work-based learning. As actively engaging young people in initiatives based on health messages is challenging, we also tested the efficacy of financial incentives in promoting initial engagement with the programme.
  
  
  METHODS
  A three-arm cluster-randomised design was used. Participants were school pupils from Year 11 and 13 (i.e., in their final year of study), aged 16-18 years. To reduce contamination effects, the unit of randomisation was school. Participants were randomly allocated to receive (i) a 12-week behavioural support intervention consisting of six appointments, (ii) a behavioural support intervention plus incentives (totalling £40), or (iii) an information-only control group. Behavioural support was provided by fitness advisors at local leisure centres following an initial consultation with a dietician. Sessions focused on promoting habit formation through setting implementation intentions as part of an incremental goal setting process. Consistent with self-determination theory, all advisors were trained to provide guidance in an autonomy-supportive manner so that they were equipped to create a social context supportive of autonomous forms of participant motivation. The primary outcome was objectively assessed physical activity (via GT1M accelerometers). Secondary outcome measures were diet, motivation and habit strength. Data were collected at baseline, post-intervention (12 weeks) and 12 months.
  
  
  CONCLUSIONS
  Findings of this trial will provide valuable insight into the feasibility of promoting autonomous engagement in healthy physical activity and dietary habits among school leavers. The research also provides much needed data and detailed information related to the use of incentives for the initial promotion of young peoples' behaviour change during this important transition.
  
  
  BACKGROUND
  The trial is registered as Current Controlled Trials ISRCTN55839517.
authors.forename: Fiona
authors.initials: F
authors.lastname: Gillison
authors.affiliation: Department for Health, University of Bath, Bath BA2 7AY, UK. M.Standage@bath.ac.uk.
authors.forename: Martyn
authors.initials: M
authors.lastname: Standage
authors.forename: Bas
authors.initials: B
authors.lastname: Verplanken
mesh_terms: D000293:Adolescent; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D016000:Cluster Analysis; D015928:Cognitive Behavioral Therapy; D004522:Educational Status; D005260:Female; D015438:Health Behavior; D006801:Humans; D008019:Life Style; D008297:Male; D012107:Research Design; D012574:Schools