Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2026-01-31
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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FFWM+
Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.
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.
Standard Care
Control Group - access to optional cooking demos
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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American Heart Association
OTHER
Ohio State University
OTHER
Responsible Party
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Colleen Spees
Professor of Medical Dietetics and Director of Hope Lab
Principal Investigators
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Colleen K Spees, PhD, MEd, RD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Ohio State Healthy Community Center
Columbus, Ohio, United States
Ohio State East Hospital
Columbus, Ohio, United States
Martha Morehouse
Columbus, Ohio, United States
Ohio State Outpatient Care Upper Arlington
Upper Arlington, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY20250193
Identifier Type: -
Identifier Source: org_study_id
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