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 clusterrandomised 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.
ResultsThe 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.
RandomisationParticipants were randomised using clusterrandomisation to minimise potential risk of contamination between programmes, clustering of outcomes, and to minimise imbalance between study groups. Participants who were supported by the same 50 L. Harris et al. • Weight loss and intellectual disabilities *Adjusted for cluster, baseline value and stratification variables (number of participants within a cluster, level of intellectual disability and presence of Down syndrome). **Data are present for objective measures on physical activity ad sedentary behaviour only due to concerns over the validity and reliability of self-report measures using the International Physical Activity Questionnaire-Short version. CI, confidence interval; cm, centimetres; ED-5D, European Quality of Life-5 dimensions; ICC, interclass correlation coefficient; kg, kilogram; m 2 , metres squared; %, percentage; MVPA, moderate to vigorous physical activity; PA, physical activity.