Medically Tailored Meals for Cardiovascular Health

NCT06550297 | Recruiting

• 2 other identifiers: AAAV068124FIM1267661
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 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. 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. 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?

Conditions

Diet, Healthy; HbA1c; Blood Pressure

Keywords

Medically Tailored Meals; Type 2 Diabetes; High Blood Pressure; Multiple Cardiometabolic Morbidity; Food is Medicine

Outcome Measures

Primary Outcomes (2)

• Change in Diet Quality

  The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 8 months will be calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).

  baseline to 8 months

• Mean Diet Quality

  The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The mean MEPA scores at 8 months will be calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).

  baseline to 8 months

Secondary Outcomes (12)

• Change in Diet Quality (Interim Change at 3 months)

  baseline, 3 months

• Mean Diet Quality (Interim at 3 months)

  baseline, 3 months

• Change in HbA1c

  baseline, 3 months, 8 months

• Mean HbA1c

  baseline, 3 months, 8 months

• Change in systolic blood pressure

  baseline, 3 months, 8 months

Other Outcomes (5)

• Food Insecurity

  baseline, 3 month, 8 months

• Nutrition Insecurity

  baseline, 3 months, 8 months

• Sleep Health

  baseline, 3 month, 8 months

Study Arms (4)

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

ACTIVE COMPARATOR

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.

Behavioral: Medically Tailored Meals and Nutritional Counseling

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

EXPERIMENTAL

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.

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

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

ACTIVE COMPARATOR

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.

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

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

EXPERIMENTAL

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.

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

Interventions

Medically Tailored Meals and Nutritional Counseling BEHAVIORAL

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.

Arm 1: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Active Comparator; Arm 2: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Intervention; Arm 3: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Active Comparator; Arm 4: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Intervention

Cardiovascular Health Promotion Educational Program BEHAVIORAL

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.

Arm 2: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Intervention; Arm 3: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Active Comparator; Arm 4: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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)
• Cancer diagnosis
• Undergoing cancer treatment
• Non-English or non-Spanish speaking
• Not cognitively able to complete study requirements
• Severe psychiatric disorders

Sponsors & Collaborators

• Columbia University: lead
• American Heart Association: collaborator

Study Sites (1)

Columbia University Mailman School of Public Health

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Nour Makarem, PhD, FAHA

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Project Coordinator

CONTACT

212-305-3317; FIM4CVH@cumc.columbia.edu

Nour Makarem, PhD, FAHA

CONTACT

nm2968@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)