Fueling Strong Hearts for South Carolina stroke survivors.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.