Randomized controlled trial of SystemCHANGE™ weight management intervention in neurological conditions.

Abstract

This randomized controlled pilot study examined the feasibility and efficacy of a SystemCHANGE™ (SC) weight management intervention in adults with either multiple sclerosis or stroke. Participants (n = 61) were randomized into two interventions: SC, which taught skills to modify personal environments, or active-control (AC), which taught health behavior guidelines. Sessions were held weekly for 12 weeks. Feasibility measures included recruitment and attrition rates. The primary outcome of body weight and secondary outcomes of emotional well-being and healthy behaviors were measured before and after the interventions. Average recruitment rate was 3.6 participants per month. Attrition rate was 14.8%. On average, 9.1 sessions were completed for SC and 10.7 for AC. Differences in weight loss were non-significant between interventions (P = 0.182), but significantly declined across both interventions (P = 0.011). Physical activity (P = 0.002), depression (P < 0.001), anxiety (P = 0.023), and self-efficacy (P = 0.022) all significantly improved for SC compared to AC. SC was feasible to implement and efficacious in improving secondary outcomes of emotional well-being and healthy behaviors, but was not efficacious in improving the primary outcome of weight loss. More research is needed to optimize SC. SC might be an alternative approach to cognitive-behavioral therapy for promoting emotional well-being and healthy behaviors.