Medically Tailored Meals for Cardiovascular Health (MTM4CVH)

Columbia University

Status: Enrolling

Conditions: HbA1c; Diet, Healthy; Blood Pressure

Treatments: Behavioral: Medically Tailored Meals and Nutritional Counseling; Behavioral: Cardiovascular Health Promotion Educational Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06550297

AAAV0681

24FIM1267661 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For Cohort A (Individuals who currently qualify for MTMs)

Inclusion Criteria:

1. Qualifying type 2 diabetes diagnosis (typically physician referred to the program due to more advanced disease with uncontrolled diabetes and complications)
2. 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 Criteria:

1. Cancer diagnosis
2. Undergoing cancer treatment
3. Non-English or non-Spanish speaking
4. Not cognitively able to complete study requirements
5. Severe psychiatric disorders
6. Inability to provide informed consent
7. 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:

1. Type 2 diabetes diagnosis (physician diagnosed or HbA1c greater than or equal to 6.5% or diabetes medication use)
2. 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)

Exclusion Criteria:

1. Cancer diagnosis
2. Undergoing cancer treatment
3. Non-English or non-Spanish speaking
4. Not cognitively able to complete study requirements
5. Severe psychiatric disorders
6. Inability to provide informed consent
7. Health conditions that could prevent safe participation or impact study outcomes (e.g., substance use disorder, dialysis, neurodegenerative conditions)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Arm 1: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Active Comparator

Active Comparator group

Description:

Participants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who currently qualify for medically tailored meals (MTMs). This arm will receive God's Love We Deliver's current MTM program, which consists of 10 home-delivered MTMs per week and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period.

Treatment:

Behavioral: Medically Tailored Meals and Nutritional Counseling

Arm 2: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Intervention

Experimental group

Description:

Participants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who currently qualify for medically tailored meals (MTMs). This arm will receive God's Love We Deliver's current MTM program, which consists of 10 home-delivered MTMs per week and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period (same as Arm 1). In addition, they will receive a 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 addressing social needs.

Treatment:

Behavioral: Cardiovascular Health Promotion Educational Program

Behavioral: Medically Tailored Meals and Nutritional Counseling

Arm 3: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Active Comparator

Active Comparator group

Description:

Participants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who do not currently qualify for medically tailored meals (MTM) programs. This arm will receive God's Love We Deliver's current MTM program, which consists of 10 home-delivered MTMs per week and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period. In addition, they will receive a 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 addressing social needs.

Treatment:

Behavioral: Cardiovascular Health Promotion Educational Program

Behavioral: Medically Tailored Meals and Nutritional Counseling

Arm 4: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Intervention

Experimental group

Description:

Participants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who do not currently qualify for medically tailored meals (MTM) programs. This arm will receive the MTM program and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period but with a distinct MTM dosing schedule. They will receive the regular MTM schedule of 10 MTMs/week for the first 3 months of the intervention. After this initial period, MTM dosing will be gradually reduced by 1 MTM each month to a target schedule of 5 MTMs/week in the final month of the intervention. In addition, they will also receive the same culturally and contextually tailored cardiovascular health promotion program as Arms 2 and 3.

Treatment:

Behavioral: Cardiovascular Health Promotion Educational Program

Behavioral: Medically Tailored Meals and Nutritional Counseling