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RECRUITING
NCT07027995
NA

Food and Fitness With Medicine (FFWM)

Sponsor: Ohio State University

View on ClinicalTrials.gov

Summary

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.

Official title: Food and Fitness With Medicine

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-01-14

Completion Date

2029-03

Last Updated

2026-02-23

Healthy Volunteers

No

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.

Locations (4)

Ohio State Healthy Community Center

Columbus, Ohio, United States

Ohio State East Hospital

Columbus, Ohio, United States

Martha Morehouse

Columbus, Ohio, United States

Ohio State Outpatient Care Upper Arlington

Upper Arlington, Ohio, United States