Food and Fitness With Medicine (FFWM)

NCT07027995 | Recruiting

• 1 other identifier: STUDY20250193
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

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

Cardiovascular Kidney Metabolic Syndrome; Type 2 Diabetes

Keywords

Food is Medicine; Cardiovascular-kidney-metabolic; Exercise is Medicine; Post-menopausal Women; Medically Tailored Groceries; Type 2 Diabetes; Glucagon-like Peptide 1 Receptor Agonists; Nutrition; Behavior; GLP-1; Weight; Fitness

Outcome Measures

Primary Outcomes (1)

• GLP-1 RA discontinuation rates

  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).

  0, 12, and 24 weeks

Secondary Outcomes (15)

• American Heart Association (AHA) PREVENT Scores

  0, 12, and 24 weeks

• Metabolites

  0, 12, and 24 weeks

• Life's Essential 8 Scores

  0, 12, and 24 weeks

• Blood Lipids

  0, 12, and 24 weeks

• Body Composition

  0, 12, and 24 weeks

Other Outcomes (3)

• Household Size and Relationships

  0, 12, and 24 weeks

• Access to Healthcare

  Baseline

• Cognitive Function

  0, 12, and 24 weeks

Study Arms (2)

FFWM+

EXPERIMENTAL

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

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

Standard Care

NO INTERVENTION

Control Group - access to optional cooking demos

Interventions

Culinary Education BEHAVIORAL

During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.

FFWM+

Food is Medicine BEHAVIORAL

During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.

FFWM+

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.

FFWM+

Nutrition Counseling BEHAVIORAL

During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.

FFWM+

Exercise is Medicine (EIM) BEHAVIORAL

During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.

FFWM+

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants identified as post-menopausal females are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ohio State University: lead
• American Heart Association: collaborator

Study Sites (4)

Ohio State Healthy Community Center

Columbus, Ohio, 43062, United States

ACTIVE NOT RECRUITING

Ohio State East Hospital

Columbus, Ohio, 43203, United States

NOT YET RECRUITING

Martha Morehouse

Columbus, Ohio, 43221, United States

RECRUITING

Ohio State Outpatient Care Upper Arlington

Upper Arlington, Ohio, 43221, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Behavior; Body Weight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Colleen K Spees, PhD, MEd, RD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna N Hauben, BS

CONTACT

9083344689; jenna.hauben@osumc.edu

Cara L Chase, BS

CONTACT

5032789721; cara.chase@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Dietetics and Director of Hope Lab

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 19, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)