Process evaluation of a cluster‐randomised controlled trial of multi‐component weight management programme in adults with intellectual disabilities and obesity

• Published in: Journal of intellectual disability research Vol. 63; no. 1; pp. 49 - 63
• Main Authors: Harris, L., Hankey, C., Jones, N., Murray, H., Pert, C., Tobin, J., Boyle, S., Shearer, R., Melville, C. A.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.01.2019
• Subjects: Adult; Adults; Body composition; Body weight; Caregivers; Clinical research; Clinical trials; Comorbidity; Comparative studies; Diet; Educational Principles; Efficacy; Evaluation; Feasibility; Feasibility Studies; Female; Fidelity; Formative Evaluation; Health education; Humans; Intellectual disabilities; Intellectual Disability; Intellectual Disability - epidemiology; Intellectual Disability - rehabilitation; Male; Obesity; Obesity - epidemiology; Obesity - therapy; Pilot Projects; Process Assessment, Health Care; process evaluation; Recruitment; Social support; TAKE 5; Waist; Weight control; Weight loss; weight management; Weight Reduction Programs - methods; Weight Reduction Programs - standards; Winners; process evaluation; weight management; TAKE 5; intellectual disabilities; obesity
• ISSN: 0964-2633; 1365-2788
• DOI: 10.1111/jir.12563

Background Providing effective weight management to adults with intellectual disabilities is necessary to challenge the high rates of obesity. The aim of this process evaluation was to explore the feasibility of conducting a full‐scale clinical trial of the TAKE 5 multi‐component weight management programme. Methods The study was a 12‐month pilot cluster‐randomised controlled trial. Adults with intellectual disabilities and obesity were randomised to either TAKE 5, which included an energy deficit diet (EDD) or Waist Winners Too, based on health education principles. A mixed‐methods process evaluation was conducted focussing on the reach, recruitment, fidelity, implementation, dose (delivered/received) and context. Results The study successfully recruited adults with intellectual disabilities. Both weight management programmes were delivered with high fidelity and implemented as intended. Only one weight management programme, TAKE 5, demonstrated potential efficacy in reducing body weight and body composition. The effectiveness was largely attributed to the EDD and social support from carers. Conclusions The extensive process evaluation illustrated that a full‐scale trial of a multi‐component programme including an EDD is feasible and an acceptable approach to weight management for adults with intellectual disabilities and obesity.