Type 2 Diabetes (T2D) Clinical Trials

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Food and Fitness With Medicine

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Martha Morehouse
RECRUITING
Columbus
Ohio State East Hospital
NOT_YET_RECRUITING
Columbus
Ohio State Healthy Community Center
ACTIVE_NOT_RECRUITING
Columbus
Ohio State Outpatient Care Upper Arlington
ACTIVE_NOT_RECRUITING
Upper Arlington
Contact Information
Primary
Jenna N Hauben, BS
jenna.hauben@osumc.edu
9083344689
Backup
Cara L Chase, BS
cara.chase@osumc.edu
5032789721
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2029-03
Participants
Target number of participants: 200
Treatments
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
Sponsors
Collaborators: American Heart Association
Leads: Ohio State University

This content was sourced from clinicaltrials.gov