title: Piloting a manualised weight management programme (Shape Up-LD) for overweight and obese persons with mild-moderate learning disabilities: study protocol for a pilot randomised controlled trial.
abstract: BACKGROUND
  National obesity rates have dramatically risen over the last decade. Being obese significantly reduces life expectancy, increases the risk of a range of diseases, and compromises quality of life. Costs to both the National Health Service and society are high. An increased prevalence of obesity in people with learning disabilities has been demonstrated. The consequences of obesity are particularly relevant to people with learning disabilities who are already confronted by health and social inequalities. In order to provide healthcare for all, and ensure equality of treatment for people with learning disabilities, services must be developed specifically with this population in mind. The aim of this project is to pilot the evaluation of a manualised weight management programme for overweight and obese persons with mild-moderate learning disabilities (Shape Up-LD).
  
  
  METHODS
  An individually randomised, controlled pilot trial in 60 overweight and obese (body mass index ≥ 25) adults (age ≥ 18) with mild-moderate learning disabilities and their carers will be carried out, comparing "Shape Up-LD" with usual care. The manualised Shape Up-LD intervention will involve 12 weekly sessions, which include healthy eating messages, advice on physical activity and use of behaviour change techniques to help people manage their weight. Assessments of participants will be conducted at baseline, 12 weeks and 6 months. Service users and their carers and service providers will also give their perspectives on the experience of Shape Up-LD in qualitative interviews at 12 weeks. Feasibility outcomes will include recruitment rates, loss to follow-up, compliance rates, completion rates, collection of information for a cost-effectiveness analysis and an estimation of the treatment effect on weight.
  
  
  CONCLUSIONS
  The findings from this study will inform our preparation for a definitive randomised controlled trial to test the efficacy of the programme with respect to weight loss and maintenance in this population. Weight loss through Shape Up-LD could lead to improvements in health and quality of life. Costs to the National Health Service might be reduced through decreased overall service use because of improved health. The programme would also ensure a more equitable service for overweight service users with learning disabilities and fill the current gap in weight management services for this population.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial No ISRCTN39605930.
authors.affiliation: Department of Epidemiology & Public Health, University College London, 1-19 Torrington Place, London, WC1E 6BT, UK. r.beeken@ucl.ac.uk
authors.forename: Rebecca J
authors.initials: RJ
authors.lastname: Beeken
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Spanos
authors.forename: Sally
authors.initials: S
authors.lastname: Fovargue
authors.forename: Rachael
authors.initials: R
authors.lastname: Hunter
authors.forename: Rumana
authors.initials: R
authors.lastname: Omar
authors.forename: Angela
authors.initials: A
authors.lastname: Hassiotis
authors.forename: Michael
authors.initials: M
authors.lastname: King
authors.forename: Jane
authors.initials: J
authors.lastname: Wardle
authors.forename: Helen
authors.initials: H
authors.lastname: Croker
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D006801:Humans; D007859:Learning Disabilities / Q000150:complications*; D009765:Obesity / Q000523:psychology / Q000628:therapy*; D050177:Overweight / Q000523:psychology / Q000628:therapy*; D010349:Patient Compliance; D010865:Pilot Projects; D018401:Sample Size; D013223:Statistics as Topic