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)
Diet, Healthy, HbA1c, Blood Pressure
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)
Medically Tailored Meals for Cardiovascular Health Equity
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Columbia University Mailman School of Public Health, New York, New York, United States, 10032
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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20 Years to
ALL
No
Columbia University,
Nour Makarem, PhD, FAHA, PRINCIPAL_INVESTIGATOR, Columbia University
2025-12