Food and Fitness With Medicine (FFWM)

What this trial studies

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 in scope

• Cardiovascular Kidney Metabolic Syndrome
• Type 2 Diabetes

Interventions

• Exercise is Medicine (EIM) (Behavioral) — During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
• Culinary Education (Behavioral) — During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
• Food is Medicine (Behavioral) — During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
• Nutrition Counseling (Behavioral) — During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
• Participant Website (Behavioral) — During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

• Diagnosis of at least one of the following conditions: hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease, and/or metabolic syndrome.
• At least 18 years of age at the time of signing consent.
• Participants must have reliable transportation to attend Exercise is Medicine sessions.
• Access to an internet-enabled device.
• No objections to online grocery shopping, home food deliveries, or nutrition counseling.
• Residence meets Instacart delivery requirements (e.g., non-institutionalized).
• Participant is willing to use a personal credit card for Instacart back-up payments.
• Participants must speak English to be able to consent and engage in FIM and EIM programs.

Exclusion criteria

• Conditions that impact digestion, metabolism, or food intake (e.g. surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.).
• Participants with uncontrolled mental illness disorders (e.g., schizophrenia, bipolar disorder, major depression, etc.) that are not well-managed or controlled through treatment, as determined by the study team.
• Familial history of certain cancers (e.g., multiple endocrine neoplasia, medullary thyroid carcinoma, etc.).
• Active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption).
• Comorbidities such as psychiatric or general illness that may put the subject at risk as determined by the investigator/s.
• Renal impairment, eGFR \< 60 ml/min/1.73m2
• Factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study.
• Recent participation (e.g., 3 months) in other behavioral nutrition trials or programs (i.e., bariatric programs, diabetes education programs).

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2026-01-14
• Primary completion: 2028-11
• Last update posted: 2026-02-23
• First posted: 2025-06-19

Sponsor & contact

Lead sponsor: Ohio State University (Other)

Collaborators: American Heart Association

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• GLP-1 RA discontinuation rates (0, 12, and 24 weeks)
  GLP-1RA discontinuation rates will be captured using the electronic medical record to obtain medication name and formulation, dosage and frequency, prescription start and end dates, prescribing provider, refill information and prescription status (active, discontinued, completed), clinic notes or medication reconciliation fields confirming ongoing use or discontinuation, pharmacy records indicating medication pick-up (when available).

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