Status:
RECRUITING
Medically Tailored Meals for Cardiovascular Health
Lead Sponsor:
Columbia University
Collaborating Sponsors:
American Heart Association
Conditions:
Diet, Healthy
HbA1c
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
This randomized clinical trial (RCT) will investigate novel approaches to enhance effectiveness, engagement, reach, and cost-effectiveness of medically tailored meals (MTM) programs for promoting card...
Detailed Description
Medically tailored meals (MTMs) represent an integral in-kind intervention of the Food Is Medicine (FIM) initiative aimed at providing healthy food in a way that is integrated with the health care sec...
Eligibility Criteria
Inclusion
- For Cohort A (Individuals who currently qualify for MTMs)
- Qualifying type 2 diabetes diagnosis (typically physician referred to the program due to more advanced disease with uncontrolled diabetes and complications)
- Hypertension diagnosis (systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 80 mmHg) or elevated blood pressure (defined as systolic blood pressure greater than or equal to 120 mmHg)
Exclusion
- Cancer diagnosis
- Undergoing cancer treatment
- Non-English or non-Spanish speaking
- Not cognitively able to complete study requirements
- Severe psychiatric disorders
- Inability to provide informed consent
- Health conditions that could prevent safe participation or impact study outcomes (e.g., substance use disorder, dialysis, neurodegenerative conditions)
- For Cohort B (Individuals who do not currently qualify for MTMs)
- Inclusion Criteria:
- Type 2 diabetes diagnosis (physician diagnosed or HbA1c greater than or equal to 6.5% or diabetes medication use)
- Hypertension diagnosis (systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 80 mmHg or physician diagnosis or hypertension medication use) or elevated blood pressure (defined as systolic blood pressure greater than or equal to 120 mmHg)
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06550297
Start Date
August 28 2024
End Date
June 1 2026
Last Update
October 24 2025
Active Locations (1)
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1
Columbia University Mailman School of Public Health
New York, New York, United States, 10032