Randomized Controlled Pilot Study of a SystemCHANGETM Weight Management Intervention in Stroke Survivors: Rationale and Protocol

Background Over 60% of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors. However, few studies have examined the effects of comprehensive lifestyle behaviour interventions to promote weight loss and control cardiovascular risk factors in stroke survivors. Thus, the purpose of this study is to examine a novel behavior change approach SystemCHANGETM to promote weight loss and improve health and function in stroke survivors. SystemCHANGETM focuses on redesigning the social environment to achieve a specific goal. Methods We will conduct a randomized controlled pilot study to examine the efficacy, feasibility and safety of the SystemCHANGETM weight management program in overweight and obese stroke survivors. The central hypothesis of the study is that the SystemCHANGETM intervention will help overweight and obese stroke survivors lose 5% of their body weight, thereby improving health and function. Thirty-five stroke survivors will be randomized into either the six-month SystemCHANGETM intervention or a contact-control intervention. Outcome measures will be assessed at baseline and again at three and six months after the interventions. Body composition will be assessed using a Bod Pod. Patient-reported outcomes will be the Stroke Impact Scale and Reintegration to Normal Living Index. Objective outcomes will include the 6-Minute Walking Test and Rivermead Motor Assessment. Discussion This study will be the first randomized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGETM approach. Furthermore, it will be the first empirically-examined comprehensive lifestyle intervention designed to target physical activity, nutrition, and sleep to promote weight loss in stroke survivors. ClinicalTrials.gov Identifier: NCT01776034