The objective of this study is to conduct a randomized controlled pilot study to examine the efficacy, feasibility and safety of the SystemCHANGE™ health promotion and wellness program in stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ program will help overweight and obese stroke survivors engaging in healthy behaviors, thereby improving health and function.
Over 60% of stroke survivors are either overweight or obese, and a projected 4.98 million stroke survivors have multiple cardiovascular risk factors. Stroke survivors are at significant risk for de-conditioning, elevated inflammatory markers, and insulin resistance, which subsequently increases risk for secondary stroke and cardiovascular disease. Engaging in healthy behaviors, such as physical activity, good sleep hygiene, and nutrition, to facilitate energy balance may help reduce the risk of secondary conditions and ultimately improve physical function and quality of life in stroke survivors. Thus, the specific study aims are to engage potential participants (i.e., stroke survivors) and their families as co-designers to adapt the SystemCHANGE™ comprehensive lifestyle intervention, and then conduct a randomized controlled pilot study to provide preliminary estimates of the intervention's efficacy in 35 stroke survivors.
- SystemCHANGE Group Lifestyle counseling Behavioral
ARM 1: Kind: Experimental Label: SystemCHANGE Group Lifestyle counseling Description: The SystemCHANGE™ intervention will be delivered over a six-month period involving 12 face-to-face group sessions (1.5 hours each) held weekly for three months, followed by three monthly "booster calls." Intervention groups include up to 10 patients, and family is encouraged to attend. Intervention sessions consist of 30-min of behavior change activities and 60-min focused on healthy behaviors.
- Phone Lifestyle Counseling Behavioral
ARM 1: Kind: Experimental Label: Phone Lifestyle Counseling Description: Participants will receive pamphlets that contain information on healthy eating, physical activity, sleep, and symptom management, and will be followed-up with telephone calls.
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Changes from baseline in body weight and percent body fat||Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline).||Yes|
|Primary||Changes from baseline in patient-reported quality of life||Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline).||No|
|Primary||Changes from baseline in physical function||Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline).||No|
|Secondary||Changes from baseline in biomarkers.||No|
|Secondary||Changes from baseline in healthy behaviors and psychosocial mediators||No|