Food and Fitness With Medicine (FFWM)

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.

Conditions

• Cardiovascular Kidney Metabolic Syndrome
• Type 2 Diabetes

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.

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• Ohio State University

  lead OTHER

Principal Investigators

• Colleen K Spees, PhD, MEd, RD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-14

Primary Completion

2028-11-30

Completion

2029-03-31

Countries

• United States

Study Locations