Food and Fitness With Medicine (FFWM)
Food and Fitness with Medicine (FFWM) is a 24-week randomized controlled trial (RCT) enrolling 200 post-menopausal women (PMW) with stage 2 cardio-kidney metabolic (CKM) syndrome and type-2 diabetes (T2D) within 6 weeks of initiating glucagon-like peptide-1 receptor agonist (GLP-1RAs) to: 1. Examine discontinuation rates of GLP-1RAs (primary outcome); 2. Compare change in American Heart Association (AHA) PREVENT scores (secondary outcome); and 3. Examine the effects of FFWM on biologic mechanisms responsive to…
Conditions studied
Cardiovascular Kidney Metabolic Syndrome, Type 2 Diabetes
About this study
Food and Fitness with Medicine (FFWM) is a 24-week randomized controlled trial (RCT) enrolling 200 post-menopausal women (PMW) with stage 2 cardio-kidney metabolic (CKM) syndrome and type-2 diabetes (T2D) within 6 weeks of initiating glucagon-like peptide-1 receptor agonist (GLP-1RAs) to: 1. Examine discontinuation rates of GLP-1RAs (primary outcome); 2. Compare change in American Heart Association (AHA) PREVENT scores (secondary outcome); and 3. Examine the effects of FFWM on biologic mechanisms responsive to weight loss and cardiovascular health (CVH) including dermal carotenoids, body composition and metabolite biomarkers.
Interventions
- Behavioral: Exercise is Medicine (EIM) — During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
- Behavioral: Culinary Education — During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
- Behavioral: Food is Medicine — During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
- Behavioral: Nutrition Counseling — During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
- Behavioral: Participant Website — During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.
Primary outcomes
- GLP-1 RA discontinuation rates (0, 12, and 24 weeks)
Eligibility information
Study locations
- Ohio State Healthy Community Center, Columbus, Ohio 43062 United States
- Ohio State East Hospital, Columbus, Ohio 43203 United States
- Martha Morehouse, Columbus, Ohio 43221 United States
- Ohio State Outpatient Care Upper Arlington, Upper Arlington, Ohio 43221 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.