Fueling Strong Hearts for South Carolina stroke survivors.
Fueling Strong Hearts for a Strong South Carolina
This program will test whether a virtual lifestyle program that adds medically tailored groceries to a peer-led exercise and nutrition class helps adults 45–80 with chronic stroke and overweight or obesity improve activity, diet, and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Clemson University Academic / other |
| Locations | 1 site (Florence, South Carolina) |
| Trial ID | NCT07140952 on ClinicalTrials.gov |
What this trial studies
This randomized virtual trial will enroll 50 community-dwelling chronic stroke survivors with overweight or obesity across the Pee Dee and Low Country regions of South Carolina. Participants will be randomly assigned to StrongPeople StrongHearts plus a medically tailored grocery (MTG) supplement (Strong SC), the conventional StrongPeople StrongHearts program (SPSH), or a wait-list control. The 12-week intervention and 12-week follow-up include measurements at baseline, 12 weeks, and 24 weeks of weight, physical activity, physical and psychosocial function, diet quality, and food security. Implementation will be evaluated using the RE-AIM and FRAME frameworks to document reach, effectiveness, adoption, implementation, and maintenance.
Who should consider this trial
Good fit: Ideal candidates are adults 45–80 years old who had a stroke at least six months ago, have a BMI over 25 kg/m2, can follow instructions and communicate symptoms, have internet access on a smartphone or computer, and are cleared to participate by study staff.
Not a fit: Patients with unstable cardiac conditions, severe uncontrolled hypertension, recent blood clots, dementia, seizure disorders, life expectancy under one year, or who cannot access the internet or are already enrolled in a rehabilitation trial are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could help stroke survivors increase physical activity, improve diet quality, reduce weight, and enhance daily functioning and quality of life.
How similar studies have performed: Community-based lifestyle and adapted physical-activity programs have improved diet, activity, and weight in older and cardiovascular populations, but they have been less tested in chronic stroke survivors, so evidence is promising but limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age 45-80 years; 2. a diagnosis of stroke at least 6 months prior; 3. BMI \> 25 kg/m2; 4. ability to follow instructions, complete training, and to communicate exertion, pain, and distress; 5. access to computer or smart phone with internet to participate in a virtual intervention; and 6. provision of informed consent. Individuals who meet inclusion criteria must complete the Physical Activity Readiness Questionnaire (PARQ) and be cleared for participation by a study exercise physiologist Exclusion Criteria: 1. unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's; 2. Alzheimer's or other dementias; 3. life expectancy \<1 yr; 4. history of DVT or pulmonary embolism within 6 months; 5. severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest; 6. history of seizures or currently prescribed anti-seizure medications; or 7. current enrollment in a rehabilitation trial to enhance physical or psychosocial recovery
Where this trial is running
Florence, South Carolina
- Pee Dee Research and Education Center — Florence, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Hannah Wilson, PhD, RDN, LD
- Email: hkw2@clemson.edu
- Phone: 478-230-0809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.