Food and Fitness With Medicine (FFWM)

Recruiting now · Not applicable

Conditions studied: Cardiovascular Kidney Metabolic Syndrome, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT07027995

Run by

Ohio State University

People needed

200

Starts

2026-01-14

Expected to finish

2029-03-01

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Participant has been clinically prescribed GLP-1RA's.

You may not qualify if…

• 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).
• Currently pregnant or planning to become pregnant during the study.
• Participant is not willing to provide a urine, blood, or stool sample.

Where it is running

• Martha Morehouse — Columbus, Ohio, United States (enrolling)
• Ohio State Healthy Community Center — Columbus, Ohio, United States
• Ohio State East Hospital — Columbus, Ohio, United States
• Ohio State Outpatient Care Upper Arlington — Upper Arlington, Ohio, United States

Full record on ClinicalTrials.gov

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