RecruitingNot ApplicableNCT07027995

Food and Fitness With Medicine (FFWM)

Food and Fitness With Medicine

Sponsor

Ohio State University

Enrollment

200 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Cardiovascular Kidney Metabolic Syndrome

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a program that combines access to healthy food (via grocery delivery) and structured exercise along with GLP-1 medication (a class of weight and diabetes drugs) to manage chronic conditions like diabetes, high blood pressure, and high cholesterol. **You may be eligible if:** - You are 18 or older - You have been diagnosed with at least one of: type 2 diabetes, high blood pressure, high cholesterol, chronic kidney disease, or metabolic syndrome - You have been prescribed a GLP-1 medication (such as semaglutide or liraglutide) by your doctor - You have reliable transportation to attend exercise sessions - You have internet access and speak English - You are comfortable with online grocery shopping and home food delivery **You may NOT be eligible if:** - You have a condition that prevents exercise participation - You do not speak English - You live outside of Instacart delivery areas - You are not currently prescribed a GLP-1 medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExercise is Medicine (EIM)

During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.

BEHAVIORALCulinary Education

During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.

BEHAVIORALFood is Medicine

During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.

BEHAVIORALNutrition Counseling

During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.

BEHAVIORALParticipant Website

During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.