NCT06550297

Medically Tailored Meals for Cardiovascular Health

Enhancing, Culturally Adapting, and Expanding Medically Tailored Meals Programs to Promote Cardiovascular Health Equity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 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.

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 sector to prevent and manage chronic disease. MTMs are a promising approach to address diet-related cardiovascular inequities, because they collectively address food and nutrition insecurity, severe illness or chronic cardiometabolic disease, and challenges with activities of daily living such as shopping for or preparing meals in those with complex medical conditions. However, additional research is needed to determine how MTM programs could be enhanced to become more culturally and contextually responsive, increase engagement with these programs, enhance their effectiveness and sustainability, and expand their reach.

Conditions

• Diet, Healthy
• HbA1c
• Blood Pressure

Interventions

Type	Name	Description
BEHAVIORAL	Medically Tailored Meals and Nutritional Counseling	God's Love We Deliver's current MTM program, which consists of weekly home-delivered MTMs and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period. The Food is Medicine Coalition Clinical Committee establishes and regularly updates the MTM Nutrition Standards, which catalogue the nutrition quality of this evidence-based intervention. Arms 1-3 will receive 10 MTMs per week for 8 months. Arm 4 will receive a distinct dosing down approach as follows: 10 MTMs/week in months 1-3, 9 MTMs/week in month 4, 8 MTMs/week in month 5, 7 MTMs/week in month 6, 6 MTMs/week in month 7, and 5 MTMs/week in month 8.
BEHAVIORAL	Cardiovascular Health Promotion Educational Program	Culturally and contextually tailored cardiovascular health promotion program that consists of didactic sessions focused on lifestyle change and the American Heart Association's Life's Essential 8 framework, setting weekly specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, group coaching, cooking demonstrations, recipes and gift bags with healthy ingredients and fresh produce, and addressing social needs.

Timeline

• Start date: 2024-08-28
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-08-13
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States