Clinical trial

Fueling Strong Hearts for a Strong South Carolina

Recruiting now · Not applicable · 1 countries · Registry ID NCT07140952

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionStroke, Obesity &Amp; Overweight

Full registry 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

Treatments and study arms

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.

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.

Primary outcomes

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

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

Stroke Impact Scale 3.0 (SIS)Baseline, post-intervention (12 weeks), and follow-up (24 weeks)

Subjective Physical and Psychosocial Function

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

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).

Study locations

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Pee Dee Research and Education Center🇺🇸 Florence, South Carolina, United States

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Hannah Wilson, PhD, RDN, LDContact

Email · Call 478-230-0809

Hannah Wilson, PhD, RDN, LDPrincipal Investigator