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]

BMC Public Health

Susan A Jebb⁵  Ann M Thomson⁷  Tim Marsh¹  Marc Suhrcke⁶  Simon R Cohn²  Lynne Cresswell⁴  Adrian Mander⁸  Jason CG Halford³  Paul N Aveyard⁵  Amy L Ahern⁷ 

[1] UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London EC4Y 8JX, UK;Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London WC1H 9SH, UK;Department of Psychological Sciences, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool L69 7ZA, UK;Else Kröner-Fresenius-Center for Nutritional Medicine, Technische Universität München, Munich, Germany;Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK;Faculty of Medicine and Health Sciences, University of East Anglia, Norwich NR4 7TJ, UK;MRC Human Nutrition Research, Elsie Widdowson Laboratory, Fulbourn Road, Cambridge CB1 9NL, UK;MRC Biostatistics Unit Hub for Trials Methodology, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, Cambridge CB2 0SR, UK

关键词: Adults;    Primary care;    Weight-loss;    Obesity;   

Others  :  1129292
DOI  :  10.1186/1471-2458-14-620

 received in 2014-06-02, accepted in 2014-06-12,  发布年份 2014

【 摘 要 】

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/Design

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.

Discussion

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.

Trial Registration

Current Controlled Trials ISRCTN82857232. Date registered: 15/10/2012.

【 授权许可】

   
2014 Ahern et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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