Fueling Strong Hearts for a Strong South Carolina

NCT07140952 | Recruiting

• 1 other identifier: 25ISA1475971
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Lifestyle Management; Virtual Intervention

Outcome Measures

Primary Outcomes (3)

• Physical Activity

  Physical activity will be assessed objectively with accelerometers as well as subjectively with the International Physical Activity Questionnaire-Short form

  Baseline, post-intervention (12 weeks), and follow-up (24 weeks)

• Stroke Impact Scale 3.0 (SIS)

  Subjective Physical and Psychosocial Function

  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).

  Baseline, post-intervention (12 weeks), and follow-up (24 weeks)

Secondary Outcomes (2)

• Weight

  Baseline, post-intervention (12 weeks), and follow-up (24 weeks)

• Food Security

  Baseline, post-intervention (12 weeks), and follow-up (24 weeks)

Study Arms (3)

StrongSC

EXPERIMENTAL

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

Behavioral: Strong SC

StrongPeople StrongHearts

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Strong SC BEHAVIORAL

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.

StrongSC

StrongPeople StrongHearts BEHAVIORAL

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.

StrongPeople StrongHearts

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 45-80 years;
• a diagnosis of stroke at least 6 months prior;
• BMI \> 25 kg/m2;
• ability to follow instructions, complete training, and to communicate exertion, pain, and distress;
• access to computer or smart phone with internet to participate in a virtual intervention; and

You may not qualify if:

• unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's;
• Alzheimer's or other dementias;
• life expectancy \<1 yr;
• history of DVT or pulmonary embolism within 6 months;
• severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest;
• history of seizures or currently prescribed anti-seizure medications; or
• current enrollment in a rehabilitation trial to enhance physical or psychosocial recovery

Sponsors & Collaborators

• Clemson University: lead
• American Heart Association: collaborator

Study Sites (1)

Pee Dee Research and Education Center

Florence, South Carolina, 29506, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Obesity; Overweight

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hannah Wilson, PhD, RDN, LD

CONTACT

478-230-0809; hkw2@clemson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 26, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)