Recruiting

FFWM with GLP-1RAs

Sponsor:

Ohio State University

Code:

NCT07027995

Conditions

Cardiovascular Kidney Metabolic Syndrome

Type 2 Diabetes

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise is Medicine (EIM)

Culinary Education

Food is Medicine

Nutrition Counseling

Participant Website

Study Details

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

Study ID

NCT07027995

Start date

Jan 14, 2026

Status verified date

Feb, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: FFWM+

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

no intervention: Standard Care

Control Group - access to optional cooking demos

Interventions

Exercise is Medicine (EIM)

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

Culinary Education

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

Food is Medicine

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

Nutrition Counseling

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

Participant Website

During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.

Primary outcome measure

  • GLP-1 RA discontinuation rates [ Time Frame: 0, 12, and 24 weeks ]

Central Contacts and Locations

Central contacts

Jenna N Hauben, BS

9083344689jenna.hauben@osumc.edu

Cara L Chase, BS

5032789721cara.chase@osumc.edu

Locations

Martha Morehouse

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Jenna Hauben

908-334-4689jenna.hauben@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-02-23.