Actively Recruiting
Medically Tailored Meals for Cardiovascular Health
Led by Columbia University · Updated on 2025-10-24
160
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 cardiovascular health, focusing on economically disadvantaged New York City neighborhoods with a disparate burden of multiple cardiometabolic diseases. The main questions the RCT aims to answer are: 1. Does enhancing MTM programs, with culturally relevant cardiovascular health curriculum (including educational sessions on heart health, healthy diet, cooking demonstrations, recipes, gift bags with healthy ingredients and fresh produce, and addressing social needs) enhance program engagement and effectiveness in improving short-term healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated to high blood pressure who currently qualify for MTM programs? 2. Is the MTM program coupled with the cardiovascular health curriculum effective for improving healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTM programs and is a gradual reduction of MTM dosing an effective and sustainable approach for expanding reach of these programs? To answer question 1, 60 participants with type 2 diabetes and elevated to high blood pressure who currently qualify for MTM programs will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) or a group that receives the standard program plus the cardiovascular health curriculum. To answer question 2, 100 participants with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTM programs (due to not having advanced disease with complications) will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) plus the cardiovascular health curriculum or a group that receives standard MTM program for the first 3 months followed by a gradual reduction in dosing of the MTMs by 50% over the remaining 5 months plus the CVH curriculum. All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality, health and lifestyle behaviors, and program engagement and implementation at baseline, 3 months, and 8 months.
CONDITIONS
Official Title
Medically Tailored Meals for Cardiovascular Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 years or older
- For Cohort A: Type 2 diabetes diagnosis with hypertension or elevated blood pressure
- For Cohort B: Type 2 diabetes diagnosis or HbA1c ≥ 6.5% or diabetes medication use
- For Cohort B: Hypertension diagnosis or elevated blood pressure or hypertension medication use
- English or Spanish speaking
- Able to provide informed consent and complete study requirements
You will not qualify if you...
- Cancer diagnosis or undergoing cancer treatment
- Non-English and non-Spanish speaking
- Unable to complete study requirements due to cognitive or psychiatric conditions
- Severe psychiatric disorders
- Health issues preventing safe participation or affecting study outcomes (e.g., substance use disorder, dialysis, neurodegenerative conditions)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Mailman School of Public Health
New York, New York, United States, 10032
Actively Recruiting
Research Team
R
Research Project Coordinator
CONTACT
N
Nour Makarem, PhD, FAHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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