Recruiting

StrongPeople StrongHearts

Sponsor:

Clemson University

Code:

NCT07140952

Conditions

Stroke

Obesity &Amp; Overweight

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Strong SC

StrongPeople StrongHearts

Study Details

Brief summary:

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.

Conditions

Stroke

Obesity &Amp; Overweight

Study ID

NCT07140952

Start date

Jun 27, 2025

Status verified date

Aug, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: StrongSC

The Strong SC arm combines the StrongPeople StrongHearts program with a supplemental medically tailored grocery (MTG) program.

experimental: StrongPeople StrongHearts

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.

no intervention: Control

No intervention will be administered during the wait-list control period.

Interventions

Strong SC

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.

StrongPeople StrongHearts

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.

Primary outcome measure

  • Physical Activity [ Time Frame: Baseline, post-intervention (12 weeks), and follow-up (24 weeks) ]
  • Stroke Impact Scale 3.0 (SIS) [ Time Frame: Baseline, post-intervention (12 weeks), and follow-up (24 weeks) ]
  • Diet Quality [ Time Frame: Baseline, post-intervention (12 weeks), and follow-up (24 weeks) ]

Central Contacts and Locations

Central contacts

Hannah Wilson, PhD, RDN, LD

478-230-0809hkw2@clemson.edu

Locations

Pee Dee Research and Education Center

Recruiting

Florence, South Carolina, United States, 29506

Contacts

Hannah Wilson, PhD, RDN, LD

478-230-0809hkw2@clemson.edu

Principal Investigator:

Hannah Wilson, PhD, RDN, LD

More Information

Sponsor

Clemson University

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Keywords

  • Lifestyle Management
  • Virtual Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clemson University on 2025-08-26.