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Recruiting NCT07027995

Food and Fitness With Medicine (FFWM)

No phase Interventional Cardiovascular Kidney Metabolic Syndrome Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise is Medicine (EIM), Culinary Education, Food is Medicine, Nutrition Counseling.
Who it may be relevant to
Registry conditions: Cardiovascular Kidney Metabolic Syndrome, Type 2 Diabetes. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Food and Fitness With Medicine

Overview

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.

Interventions

  • Behavioral Exercise is Medicine (EIM)
    During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
  • Behavioral Culinary Education
    During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
  • Behavioral Food is Medicine
    During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
  • Behavioral Nutrition Counseling
    During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
  • Behavioral 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 measures

  • GLP-1 RA discontinuation rates [Time frame: 0, 12, and 24 weeks]
Secondary outcome measures (12)
  • American Heart Association (AHA) PREVENT Scores [Time frame: 0, 12, and 24 weeks]
  • Metabolites [Time frame: 0, 12, and 24 weeks]
  • Life's Essential 8 Scores [Time frame: 0, 12, and 24 weeks]
  • Blood Lipids [Time frame: 0, 12, and 24 weeks]
  • Body Composition [Time frame: 0, 12, and 24 weeks]
  • Dietary Patterns [Time frame: 0, 12, and 24 weeks]
  • Hip Circumference [Time frame: 0, 12, and 24 weeks]
  • Dermal Carotenoid Scores [Time frame: 0, 12, and 24 weeks]
  • Blood Pressure [Time frame: 0, 12, and 24 weeks]
  • Nutrition Security [Time frame: 0, 12, 24 weeks.]
  • Social and Emotional Wellbeing [Time frame: 0, 12, and 24 weeks]
  • Social Needs [Time frame: 0, 12, and 24 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 4 centers
  • Ohio State Healthy Community Center — Columbus
  • Ohio State East Hospital — Columbus
  • Martha Morehouse — Columbus
  • Ohio State Outpatient Care Upper Arlington — Upper Arlington

Identifiers

NCT: NCT07027995 · STUDY20250193

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗