Health Promotion and Wellness Program for Stroke Survivors

• Changes from baseline in body weight and percent body fat [ Time Frame: 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). ] [ Designated as safety issue: Yes ]
  body weight and percent body fat will be measured with the Bod Pod
  
  
• Changes from baseline in patient-reported quality of life [ Time Frame: 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). ] [ Designated as safety issue: No ]
  Stroke Impact Scale and Reintegration to Normal Living Index will be administered.
  
  
• Changes from baseline in physical function [ Time Frame: 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). ] [ Designated as safety issue: No ]
  6-Minute Walking Test and Rivermead Motor Assessment will be conducted.
  
  

• Changes from baseline in biomarkers. [ Time Frame: 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). ] [ Designated as safety issue: No ]
  Blood draws will be performed for cholesterol, triglycerides, C-reactive protein, and hemoglobin A1c.
  
  
• Changes from baseline in healthy behaviors and psychosocial mediators [ Time Frame: 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). ] [ Designated as safety issue: No ]
  A three-day food diary, the Physical Activity and Disability Survey, and sleep quality measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)will be administered. Potential psychosocial mediators that will be measured include self-efficacy for diet, physical activity, and self-management, and social support for healthy behaviors.
  
  

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.