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Tests food and fitness programs alongside GLP-1 medicine in women with diabetes

Tests food and exercise support in postmenopausal women with diabetes starting GLP-1 medicines.

Key facts

Who runs it
Ohio State University
Where
Columbus and Upper Arlington, United StatesSee the 4 sites
Trial code
Registry title
Food and Fitness With Medicine (FFWM)
Status
Recruiting
People taking part
200 people, planned
Started
14 Jan 2026
Expected to end
Mar 2029
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Exercise is Medicine (EIM)
  • Culinary Education
  • Food is Medicine
  • Nutrition Counseling
  • Participant Website
Record updated
23 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 or older who have been prescribed a GLP-1RA medicine and have a condition such as type 2 diabetes, high blood pressure or chronic kidney disease. It tests a food and fitness programme alongside the medicine.

Age
18 years or older
Sex
Women only
Disease stage
At least one of: hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease and/or metabolic syndrome.
Earlier treatment
Must have been clinically prescribed a GLP-1RA medicine. Must not have joined another behavioral nutrition trial or program in the last 3 months (for example bariatric or diabetes education programs).

Main reasons for not taking part

  • Conditions that affect digestion, metabolism or food intake (for example bariatric surgery or surgical loss of the stomach)
  • Poorly controlled mental illness
  • Kidney impairment with eGFR below 60 ml/min/1.73m2
  • Active digestive illness such as Celiac disease or irritable bowel syndrome
  • Currently pregnant or planning to become pregnant during the study

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • Currently pregnant or planning to become pregnant during the study
  • Participant is not willing to provide a urine, blood, or stool sample

Where in United States

  • Martha MorehouseColumbus, United StatesContact: Jenna HaubenTaking people
  • Ohio State East HospitalColumbus, United StatesContact: Luiza Reopell, MBANot yet recruiting
  • Ohio State Healthy Community CenterColumbus, United StatesContact: Jenna N Hauben, BSNo longer taking part
  • Ohio State Outpatient Care Upper ArlingtonUpper Arlington, United StatesContact: Jenna N Hauben, BSNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • FFWM+Treatment being tested

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

    Treatment: Exercise is Medicine (EIM), Culinary Education, Food is Medicine, Nutrition Counseling, and Participant Website

  • Standard CareNo study treatment, for comparison

    Control Group - access to optional cooking demos

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Food and Fitness With Medicine
Plain-language title
Tests food and fitness programs alongside GLP-1 medicine in women with diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 February 2026