An interventional study of Strong SC and StrongPeople StrongHearts in Stroke and Obesity &Amp; Overweight, sponsored by Clemson University. Recruiting at 1 site in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Clemson University · Not applicable, Interventional, and Treatment
South Carolina is home to many survivors of stroke. After leaving the hospital and finishing therapies, stroke survivors often do not have the supports they need to fully recover. Many live with problems for a long time after their stroke, such as trouble walking or doing everyday tasks like cleaning, grocery shopping, or cooking. Research suggests that healthy habits, like moving more, eating well, and being at a healthy weight, can improve most of these disabilities. These habits can be hard to form alone though, especially in rural areas that may not have many healthy foods or places to exercise. Research-based programs can help people form healthy habits. These programs have not been tested in stroke survivors who have different needs though. The goal of this research project is to test StrongPeople StrongHearts, a health program, to see if it helps stroke survivors in South Carolina make better choices for their health and improve their quality of life. The program will be delivered online so that survivors in rural areas can be in the program. One group will also receive a weekly grocery box tailored to their needs to improve access to healthy foods. This study could help increase access to research-based programs for stroke survivors who do not have the supports they did soon after their stroke. This step is important for stroke survivors' long-term health and quality of life, the mission of the American Heart Association.
This study will be conducted virtually throughout the Pee Dee and Low Country regions of South Carolina. The purpose of this project is to determine the extent to which Strong SC, an intervention combining StrongPeople StrongHearts with a supplemental medically tailored grocery (MTG) program, impacts lifestyle behaviors and health outcomes of community-dwelling chronic stroke survivors with obesity, compared to the conventional StrongPeople StrongHearts intervention. A total of 50 community-dwelling chronic stroke survivors with overweight or obesity will be randomly assigned to one of three groups: 1) StrongPeople StrongHearts + supplemental MTG program (Strong SC); 2) the conventional StrongPeople StrongHearts program (SPSH); or 3) a wait-list control (CON). SPSH participants will have access to the supplemental MTG program following completion of the 12-week intervention and 12-week follow-up period, and CON participants will be enrolled in the Strong SC intervention following the 12-week intervention and 12-week follow-up period. Anthropometric measures, physical activity, physical and psychosocial function, diet quality, and food security (Aim 1) outcome measures will be assessed prior to the intervention (baseline), at 12 weeks (post), and at 24 weeks (follow-up). The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Framework for Reporting Adaptations and Modifications-Expanded (FRAME) frameworks will be utilized to evaluate implementation outcomes and systematic adaptations to StrongPeople StrongHearts (Aim 2). Any StrongPeople StrongHearts program adaptations required, systematically made, and documented will apply to both the Strong SC and SPSH intervention groups.
Exclusion Criteria:
The Strong SC arm combines the StrongPeople StrongHearts program with a supplemental medically tailored grocery (MTG) program.
Behavioral: Strong SC
The StrongPeople StrongHearts arm follows the standard 12-week StrongPeople StrongHearts group program, systematically adapted to the needs and abilities of community-dwelling, chronic stroke survivors.
Behavioral: StrongPeople StrongHearts
No intervention will be administered during the wait-list control period.
The Strong SC intervention combines the StrongPeople StrongHearts program with a supplemental medically tailored grocery program. The StrongPeople StrongHearts program is a 12-week group program, with two meetings per week, that incorporates education on nutrition and physical activity for weight management and cardiovascular health, as well as strength training and aerobic exercises. The supplemental MTG program will utilize a grocery delivery platform(s) to deliver a weekly medically tailored grocery box of produce worth approximately $30 (costs covered by grant funds). Box contents will be tailored by the PI, who is a registered dietitian licensed in South Carolina, to participants' nutrition needs and functional abilities (e.g., pre-cut vegetables for participants with limited hand functionality). Participants will receive an allotment of produce each week, as well as a recipe(s) and virtual cooking demonstration providing practical strategies on incorporating each week's produce.
The StrongPeople StrongHearts program is a 12-week group program, with two meetings per week, that incorporates education on nutrition and physical activity for weight management and cardiovascular health, as well as strength training and aerobic exercises. Participants of this intervention will receive a systematically adapted version of this program tailored to the physical capacities of the target population (chronic stroke survivors). The systematically adapted version of StrongPeople StrongHearts will be used across both experimental arms in this study.
Physical Activity
Physical activity will be assessed objectively with accelerometers as well as subjectively with the International Physical Activity Questionnaire-Short form
Time frame: Baseline, post-intervention (12 weeks), and follow-up (24 weeks)
Stroke Impact Scale 3.0 (SIS)
Subjective Physical and Psychosocial Function
Time frame: Baseline, post-intervention (12 weeks), and follow-up (24 weeks)
Diet Quality
Diet quality will be assessed with the Healthy Eating Index-2020, calculated from two 24-hour recalls collected using the Automated Self-Administered 24-hour recall. Diet quality will also be assessed with the 26-item Dietary Screener Questionnaire (DSQ).
Time frame: Baseline, post-intervention (12 weeks), and follow-up (24 weeks)
Weight
Weight will be self-reported but measured using clinical-grade scales provided to participants for the course of the intervention.
Time frame: Baseline, post-intervention (12 weeks), and follow-up (24 weeks)
Food Security
Household food security will be assessed with the Six-item Short Form of the Food Security survey module developed by the USDA Economic Research Service
Time frame: Baseline, post-intervention (12 weeks), and follow-up (24 weeks)
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