Fueling Strong Hearts for a Strong South Carolina

NCT ID: NCT07140952

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2028-03-31

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.

Detailed Description

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.

Conditions

Stroke; Obesity &Amp; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

StrongSC

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

Group Type: EXPERIMENTAL

Strong SC

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

StrongPeople StrongHearts

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility 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

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Clemson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pee Dee Research and Education Center

Florence, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hannah Wilson, PhD, RDN, LD

Role: CONTACT

hkw2@clemson.edu

478-230-0809

Facility Contacts

Hannah Wilson, PhD, RDN, LD

Role: primary

hkw2@clemson.edu

478-230-0809

Other Identifiers

25ISA1475971

Identifier Type: -

Identifier Source: org_study_id