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Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Food and Fitness With Medicine for Post‑menopausal Women with Type 2 Diabetes and Cardio‑Kidney‑Metabolic Syndrome

Official title: Food and Fitness With Medicine

Run by Ohio State University · NCT07027995 · Data updated 2026-11-12

This 24‑week randomized test sees if adding tailored groceries, nutrition counseling, culinary education, and supervised exercise helps post‑menopausal women with type 2 diabetes who just started GLP‑1 receptor agonists stay on their medicine and improve heart and metabolic health.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment200 (estimated)
SponsorOhio State University
Academic / other
Locations4 sites (Columbus, Ohio and 3 other locations)
StatusRecruiting
StartedJanuary 14, 2026
Main results expectedNovember 2028
Study endsMarch 2029
Registry record updatedFebruary 23, 2026
Trial IDNCT07027995 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are post‑menopausal women with type 2 diabetes and stage 2 cardio‑kidney‑metabolic syndrome who have been prescribed a GLP‑1 receptor agonist within the past six weeks, have reliable transportation for exercise sessions, internet access, and live in an area that accepts Instacart delivery.

Probably not a fit

Patients with major digestive or absorptive conditions (for example prior bariatric surgery, pancreatic dysfunction, or other surgical loss of GI tract), those who cannot use online grocery delivery, non‑English speakers, men, or people who are not recently started on a GLP‑1RA are unlikely to benefit from or be eligible for this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

FFWM is a 24‑week randomized controlled trial enrolling 200 post‑menopausal women with stage 2 cardio‑kidney‑metabolic syndrome and type 2 diabetes within six weeks of starting a GLP‑1 receptor agonist. Participants are randomized to a multi-component intervention combining Exercise is Medicine sessions, culinary education, medically tailored groceries/food delivery, one-on-one nutrition counseling, and a participant website versus usual care. The primary outcome is GLP‑1RA discontinuation rate, with secondary outcomes including change in the American Heart Association PREVENT score and changes in dermal carotenoids, body composition, and metabolite biomarkers. The protocol requires in-person exercise attendance at Ohio State sites and ability to receive online grocery deliveries and use internet-enabled devices.

Why it matters

Potential benefit: If successful, FFWM could improve medication persistence and produce meaningful gains in cardiovascular and metabolic health for post‑menopausal women on GLP‑1RAs.

How similar studies have gone: Previous programs combining medically tailored food and exercise have improved weight, glycemic control, and cardiovascular risk markers, but applying these supports specifically to improve GLP‑1RA persistence in post‑menopausal CKM patients is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Martha Morehouse
    Columbus, Ohio, United States     Recruiting
  • Ohio State Healthy Community Center
    Columbus, Ohio, United States     Active not recruiting
  • Ohio State East Hospital
    Columbus, Ohio, United States     Not yet recruiting
  • Ohio State Outpatient Care Upper Arlington
    Upper Arlington, Ohio, United States     Active not recruiting

Study contacts

  • Principal investigator: Colleen K Spees, PhD, MEd, RD — Ohio State University
  • Study coordinator: Jenna N Hauben, BS
  • Email: jenna.hauben@osumc.edu
  • Phone: 9083344689

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Cardiovascular-kidney-metabolic Syndrome 5Type 2 Diabetes 581Ohio State University 1291
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.