title: Weight loss referrals for adults in primary care (WRAP): protocol for a multi-centre randomised controlled trial comparing the clinical and cost-effectiveness of primary care referral to a commercial weight loss provider for 12 weeks, referral for 52 weeks, and a brief self-help intervention [ISRCTN82857232].
abstract: BACKGROUND
  Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider for weight management. Commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money.
  
  
  METHODS
  This multicentre, randomised controlled trial with a parallel design will recruit 1200 overweight adults (BMI ≥28 kg/m2) through their primary care provider. They will be randomised in a 2:5:5 allocation to: Brief Intervention, Commercial Programme for 12 weeks, or Commercial Programme for 52 weeks. Participants will be followed up for two years, with assessments at 0, 3, 12 and 24 months. The sequential primary research questions are whether the CP interventions achieve significantly greater weight loss from baseline to 12 months than BI, and whether CP52 achieves significantly greater weight loss from baseline to 12 months than CP12. The primary outcomes will be an intention to treat analysis of between treatment differences in body weight at 12 months. Clinical effectiveness will be also be assessed by measures of weight, fat mass, and blood pressure at each time point and biochemical risk factors at 12 months. Self-report questionnaires will collect data on psychosocial factors associated with adherence, weight-loss and weight-loss maintenance. A within-trial and long-term cost-effectiveness analysis will be conducted from an NHS perspective. Qualitative methods will be used to examine the participant experience.
  
  
  CONCLUSIONS
  The current trial compares the clinical and cost effectiveness of referral to a commercial provider with a brief intervention. This trial will specifically examine whether providing longer weight-loss treatment without altering content or intensity (12 months commercial referral vs. 12 weeks) leads to greater weight loss at one year and is sustained at 2 years. It will also evaluate the relative cost-effectiveness of the three interventions. This study has direct implications for primary care practice in the UK and will provide important information to inform the decisions of practitioners and commissioners about service provision.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN82857232. Date registered: 15/10/2012.
authors.affiliation: MRC Human Nutrition Research, Elsie Widdowson Laboratory, Fulbourn Road, Cambridge CB1 9NL, UK. Amy.Ahern@mrc-hnr.cam.ac.uk.
authors.forename: Amy L
authors.initials: AL
authors.lastname: Ahern
authors.forename: Paul N
authors.initials: PN
authors.lastname: Aveyard
authors.forename: Jason Cg
authors.initials: JC
authors.lastname: Halford
authors.forename: Adrian
authors.initials: A
authors.lastname: Mander
authors.forename: Lynne
authors.initials: L
authors.lastname: Cresswell
authors.forename: Simon R
authors.initials: SR
authors.lastname: Cohn
authors.forename: Marc
authors.initials: M
authors.lastname: Suhrcke
authors.forename: Tim
authors.initials: T
authors.lastname: Marsh
authors.forename: Ann M
authors.initials: AM
authors.lastname: Thomson
authors.forename: Susan A
authors.initials: SA
authors.lastname: Jebb
mesh_terms: D000293:Adolescent; D000328:Adult; D003132:Commerce; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D009765:Obesity / Q000628:therapy*; D050177:Overweight; D011320:Primary Health Care; D012017:Referral and Consultation; D012107:Research Design; D012307:Risk Factors; D012648:Self Care; D011795:Surveys and Questionnaires; D013997:Time Factors; D015431:Weight Loss; D061217:Weight Reduction Programs / Q000191:economics