NCT07027995Recruiting
Food and Fitness With Medicine (FFWM)
Food and Fitness With Medicine
Source: ClinicalTrials.gov · Last updated 23 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 4 Jun 2025
- Start date
- 14 Jan 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Ohio State University
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07027995
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 14 Jan 2026 to the primary completion date, 30 Nov 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Recent participation (e.g., 3 months) in other behavioral nutrition trials or programs (i.e., bariatric programs, diabetes education programs).
Lab values
- Renal impairment, eGFR \< 60 ml/min/1.73m2
Other
- Factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study.
- Currently pregnant or planning to become pregnant during the study.
- Participant is not willing to provide a urine, blood, or stool sample.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State Healthy Community Center Coordinator of this site? Confirm its status | Columbus | United States | Active, not recruiting |
| Ohio State East Hospital Coordinator of this site? Confirm its status | Columbus | United States | Not yet recruiting |
| Martha Morehouse Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Ohio State Outpatient Care Upper Arlington Coordinator of this site? Confirm its status | Upper Arlington | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.