Randomized controlled pilot study of a SystemCHANGE™ weight management intervention in stroke survivors: rationale and protocol
1 Department of Biomedical Engineering, Physical Medicine and Rehabilitation; Cleveland Clinic Lerner Research Institute, 9500 Euclid Ave, ND-20, Cleveland, OH, 44195, USA
2 The Edward and Louise Mellen Professor of Nursing and Associate Dean for Research; Frances Payne Bolton School of Nursing, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH, 44106, USA
3 Department of Pathobiology, Cleveland Clinic Lerner Research Institute, Cleveland, OH, 44195, USA
4 Department Chair, Physical Medicine and Rehabilitation, Cleveland Clinic Neurological Institute, Cleveland, OH, 44195, USA
5 Neurological Institute Center for Outcomes Research and Evaluation, Cleveland Clinic, Cleveland, OH, 44195, USA
6 Cerebrovascular Center, Cleveland Clinic Neurological Institute, Cleveland, OH, 44195, USA
7 Department of Biomedical Engineering, Center for Neurological Restoration; Cleveland Clinic Lerner Research Institute, 9500 Euclid Ave, ND-20, Cleveland, OH, 44195, USA
Trials 2013, 14:130 doi:10.1186/1745-6215-14-130Published: 7 May 2013
Over 65% of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors. However, few studies have examined the effects of comprehensive lifestyle behavior 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 - SystemCHANGE™ - to promote weight loss and improve health and function in stroke survivors. SystemCHANGE™ focuses on redesigning the social environment to achieve a specific goal.
We will conduct a randomized controlled pilot study to examine the efficacy, feasibility, and safety of the SystemCHANGE™ weight management program in overweight and obese stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ 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 6-month SystemCHANGE™ intervention or a contact-control intervention. Outcome measures will be assessed at baseline and again at 3 and 6 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.
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 SystemCHANGE™ 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