title: A single-blind, pilot randomised trial of a weight management intervention for adults with intellectual disabilities and obesity: study protocol.
abstract: BACKGROUND
  The prevalence of obesity in adults with intellectual disabilities has consistently been reported to be higher than the general population. Despite the negative impact of obesity on health, there is little evidence of the effectiveness of weight management interventions for adults with intellectual disabilities and obesity. Preliminary results from a single-stranded feasibility study of a multi-component weight management intervention specifically designed for adults with intellectual disabilities and obesity (TAKE 5) and that satisfied clinical recommendations reported that it was acceptable to adults with intellectual disabilities and their carers. This study aims to determine the feasibility of a full-scale clinical trial of TAKE 5.
  
  
  METHODS
  This study will follow a pilot randomised trial design. Sixty-six obese participants (body mass index (BMI) ≥30 kg/m2) will be randomly allocated to the TAKE 5 multi-component weight management intervention or a health education 'active' control intervention (Waist Winners Too (WWToo)). Both interventions will be delivered over a 12-month period. Participants' anthropometric measures (body weight, BMI, waist circumference, percentage body fat); indicators of activity (levels of physical activity and sedentary behaviour) and well-being will be measured at three time points: baseline, 6 and 12 months. The researcher collecting outcome measures will be blind to study group allocation.
  
  
  CONCLUSIONS
  The data from this study will generate pilot data on the acceptability of randomisation, attrition rates and the estimates of patient-centred outcomes of TAKE 5, which will help inform future research and the development of a full-scale randomised clinical trial.
  
  
  BACKGROUND
  ISRCTN52903778.
authors.affiliation: College of Medical Veterinary and Life Sciences, Institute of Mental Health & Wellbeing, University of Glasgow, Glasgow, G12 0XH UK.
authors.forename: Leanne
authors.initials: L
authors.lastname: Harris
authors.affiliation: Learning Disabilities Psychiatry, Institute of Health & Wellbeing, College of Medical Veterinary and Life Sciences, University of Glasgow, Academic Unit for Mental Health & Wellbeing, Gartnavel Royal Hospital, 1st floor Administrative Building, 1055 Great Western Road, Glasgow, G12 0XH UK.
authors.forename: Craig
authors.initials: C
authors.lastname: Melville
authors.affiliation: College of Medical Veterinary and Life Sciences, Institute of Mental Health & Wellbeing, University of Glasgow, Glasgow, G12 0XH UK.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Jones
authors.affiliation: Learning Disability Psychology NHS Greater Glasgow and Clyde, Glasgow, G52 2HH UK.
authors.forename: Carol
authors.initials: C
authors.lastname: Pert
authors.affiliation: Glasgow and Clyde Weight Management Service, Glasgow, G41 3DX UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Boyle
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, G12 8QQ UK.
authors.forename: Heather
authors.initials: H
authors.lastname: Murray
authors.affiliation: Glasgow City CHP North East Sector, Eastbank Conference Training Centre, Glasgow, G32 9AA UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Tobin
authors.affiliation: North East Quadrant Shettleston Health Centre, Glasgow, G32 7JZ UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Gray
authors.affiliation: Human Nutrition, College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, G31 2ER UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hankey
keywords: Intellectual disability; Obesity; TAKE 5; Weight management