Clinical trial NCT06550297: Medically Tailored Meals for Cardiovascular Health Equity
Official title: Enhancing, Culturally Adapting, and Expanding Medically Tailored Meals Programs to Promote Cardiovascular Health Equity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet, Healthy
HbA1c
Blood Pressure
Keywords: Medically Tailored Meals
Type 2 Diabetes
High Blood Pressure
Cardiovascular Inequities
Food is Medicine
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 equity, 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 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 blood pressure who currently qualify for MTM programs?
2. Is the MTM program coupled with the Cardiovascular Health (CVH) curriculum effective for improving healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated blood pressure who do not currently quality 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, 100 participants with type 2 diabetes and elevated 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 blood pressure who do not currently qualify for MTM programs 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.

(Objectives)

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.

Eligibility 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

For Cohort B (Individuals who do not currently qualify for MTMs)

Inclusion Criteria:

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

Primary outcomes:
measure: Change in Diet Quality
timeFrame: baseline to 8 months
measure: Mean Diet Quality
timeFrame: baseline to 8 months
Secondary outcomes:
measure: Change in Diet Quality (Interim Change at 3 months)
timeFrame: baseline, 3 months
measure: Mean Diet Quality (Interim at 3 months)
timeFrame: baseline, 3 months
measure: Change in HbA1c
timeFrame: baseline, 3 months, 8 months
measure: Mean HbA1c
timeFrame: baseline, 3 months, 8 months
measure: Change in systolic blood pressure
timeFrame: baseline, 3 months, 8 months
measure: Change in diastolic blood pressure
timeFrame: baseline, 3 months, 8 months
measure: Mean systolic blood pressure
timeFrame: baseline, 3 months, 8 months
measure: Mean diastolic blood pressure
timeFrame: baseline, 3 months, 8 months
measure: Acceptability of Implementation
timeFrame: 8 months
measure: Feasibility of Implementation
timeFrame: 8 months
measure: Appropriateness of Implementation
timeFrame: 8 months
measure: Satisfaction with Intervention
timeFrame: 8 months
Other outcomes:
measure: Food Insecurity
timeFrame: baseline, 3 month, 8 months
measure: Nutrition Insecurity
timeFrame: baseline, 3 months, 8 months
measure: Sleep Health
timeFrame: baseline, 3 month, 8 months
measure: Self-rated health
timeFrame: baseline, 3 months, 8 months
measure: General Health Status
timeFrame: baseline, 3 month, 8 months
Locations:
city: New York
country: United States
facility: Columbia University Mailman School of Public Health
state: New York
Study officials:
affiliation: Columbia University
name: Nour Makarem, PhD, FAHA
role: PRINCIPAL_INVESTIGATOR
References: