Food and Fitness With Medicine (FFWM)

The Ohio State University

Status: Enrolling

Conditions: Cardiovascular Kidney Metabolic Syndrome; Type 2 Diabetes

Treatments: Behavioral: Culinary Education; Behavioral: Food is Medicine; Behavioral: Participant Website; Behavioral: Exercise is Medicine (EIM); Behavioral: Nutrition Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT07027995

STUDY20250193

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

FFWM+

Experimental group

Description:

Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.

Treatment:

Behavioral: Nutrition Counseling

Behavioral: Exercise is Medicine (EIM)

Behavioral: Participant Website

Behavioral: Food is Medicine

Behavioral: Culinary Education

Standard Care

No Intervention group

Description:

Control Group - access to optional cooking demos