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Food and Fitness With Medicine (FFWM)
Food and Fitness With Medicine
Who can join
Ages 18 and older · Women
Full eligibility criteria
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. * Participant has been clinically prescribed GLP-1RA's. 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). * Currently pregnant or planning to become pregnant during the study. * Participant is not willing to provide a urine, blood, or stool sample.
About the study
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.
What is being tested
- Exercise is Medicine (EIM) (behavioral)
- Culinary Education (behavioral)
- Food is Medicine (behavioral)
- Nutrition Counseling (behavioral)
- Participant Website (behavioral)
Sponsor: Ohio State University · Participants: 200 · Started: Jan 14, 2026
Contact the study team
- Jenna N Hauben, BS · Phone: 9083344689
- Cara L Chase, BS · Phone: 5032789721
Official record on ClinicalTrials.gov — NCT07027995
Locations in the U.S.
| Ohio | Martha Morehouse, Columbus Ohio State East Hospital, Columbus (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.