Medically Tailored Meals for High Blood Pressure

(MTM4CVH Trial)

Overseen By Research Project Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Cancer, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 8 months

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Medically Tailored Meals for High Blood Pressure?

Research shows that medically tailored meals (MTMs) can help manage chronic conditions like type 2 diabetes and reduce healthcare use for diet-related diseases. Additionally, a comprehensive nutrition plan has been shown to improve cardiovascular risk factors, including lowering blood pressure. ^{1 2 3 4 5}

Is it safe for humans to use medically tailored meals for health conditions?

Research on medically tailored meals (MTMs) suggests they are generally safe for humans, as they are designed to provide balanced nutrition and have been used in studies for conditions like diabetes and cardiovascular health without reported safety issues. ^{1 2 3 5 6}

How is the treatment of Medically Tailored Meals and Nutritional Counseling unique for high blood pressure?

Medically Tailored Meals and Nutritional Counseling is unique because it involves healthcare providers prescribing pre-prepared meals specifically designed to manage chronic conditions like high blood pressure, combined with nutrition education, which is different from traditional medication or self-selected dietary changes. ^{1 2 3 5 7}

What is the purpose of this trial?

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)

Research Team

Nour Makarem, PhD, FAHA

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for people living in economically disadvantaged areas of New York City who have type 2 diabetes and high blood pressure. Participants must currently qualify for medically tailored meals (MTM) due to advanced uncontrolled diabetes with complications, or have a systolic blood pressure of at least 130 mmHg or diastolic blood pressure of at least 80 mmHg.

Inclusion Criteria

I qualify for MTMs.

I have type 2 diabetes with complications and it's not well-controlled.

I have high blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored meals (MTMs) and nutritional counseling for 8 months. Some participants also receive a cardiovascular health curriculum.

8 months

Baseline, 3 months, 8 months

Follow-up

Participants are monitored for changes in diet quality, blood pressure, HbA1c, and other health measures.

8 months

3 visits (in-person or virtual)

Extension

Participants may continue to receive reduced MTM dosing and cardiovascular health curriculum.

5 months

Treatment Details

Interventions

• Cardiovascular Health Promotion Educational Program
• Medically Tailored Meals and Nutritional Counseling

Trial Overview The study tests if adding a cardiovascular health curriculum to the standard MTM program improves engagement and effectiveness in promoting heart-healthy behaviors and clinical outcomes like HbA1c levels and blood pressure. It also examines whether reducing MTMs after initial full dosing can sustain these benefits.

Participant Groups

Group I: Arm 4: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Intervention Experimental Treatment 2 Interventions

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.

Group II: Arm 2: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Intervention Experimental Treatment 2 Interventions

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.

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

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.

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

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.

Medically Tailored Meals and Nutritional Counseling is already approved in United States, European Union for the following indications:

Approved in United States as Medically Tailored Meals for:

• Type 2 diabetes
• Elevated blood pressure
• Cardiovascular health
• Chronic kidney disease
• Cancer
• Congestive heart failure

Approved in European Union as Medically Tailored Meals for:

• Malnutrition
• Food insecurity
• Chronic health conditions
• Cardiovascular diseases

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Findings from Research

A study involving 650 patients with chronic conditions found that receiving medically tailored meals (MTM) for 2 weeks led to a significant reduction in anxiety and depression scores compared to baseline, while the 4-week group did not show similar improvements.

However, there were no significant differences in overall patient outcomes, such as activities of daily living, nutritional risk, or rates of emergency department visits and rehospitalizations, between the 2-week and 4-week MTM groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. Boxer, R., Drace, ML., Kelly, C., et al.[2023]

This study will evaluate the efficacy of a Medically Tailored Meals (MTM) program for individuals with type 2 diabetes and hyperglycemia, involving 212 participants over 26 weeks, to see if it can improve their blood sugar levels and overall health.

The trial aims to provide valuable data on the clinical outcomes of MTM, which could support its large-scale implementation in healthcare systems to help manage chronic conditions like diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. Law, KK., Coyle, DH., Neal, B., et al.[2023]

Implementing national coverage for medically tailored meals (MTMs) could potentially prevent approximately 1.6 million hospitalizations and save $13.6 billion in health care costs annually for patients with diet-related diseases.

Over a 10-year period, MTM coverage could lead to an estimated 18.3 million averted hospitalizations and $484.5 billion in reduced health care expenditures, highlighting the significant cost-effectiveness of this intervention for patients with chronic diet-sensitive conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. Hager, K., Cudhea, FP., Wong, JB., et al.[2023]

A program providing medically tailored meals (MTM) to recently discharged hospital patients resulted in 65% of participants reporting high satisfaction with the meals, indicating a positive impact on their recovery experience.

Participants noted that the MTM helped them by providing sufficient and healthy food, convenience, and ease of preparation, suggesting that such interventions can support recovery and independence after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant perspectives on the impact of receiving medically tailored meals on post-hospitalization. Kelly, C., Gleason, K., Drace, M., et al.[2023]

A comprehensive meal program (CCNW) significantly lowered blood pressure and improved cardiovascular risk factors in 101 participants with mild-to-moderate hypertension, showing greater benefits than a self-selected diet.

The CCNW plan led to better outcomes in cholesterol, LDL levels, HbA1c, and overall nutrient intake, while also enhancing compliance and quality of life, highlighting the importance of a complete dietary approach over focusing on individual nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive nutrition plan improves cardiovascular risk factors in essential hypertension. McCarron, DA., Oparil, S., Resnick, LM., et al.[2019]

In a study of 560 adults, those following a nutrient-fortified prepared meal plan showed significantly better compliance with dietary guidelines compared to those on a self-selected mixed-food plan, leading to improved cardiovascular health outcomes.

Participants who adhered to the dietary plans experienced greater reductions in body weight, blood pressure, and cholesterol levels, highlighting the effectiveness of structured meal plans in managing cardiovascular disease risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary compliance and cardiovascular risk reduction with a prepared meal plan compared with a self-selected diet. Metz, JA., Kris-Etherton, PM., Morris, CD., et al.[2019]

The Hypertension Diet Education Program successfully trained practical nurses to provide culturally relevant nutritional counseling, leading to significant improvements in their knowledge and skills.

Among the patients counseled, 63% achieved controlled blood pressure readings within eight months, demonstrating the program's effectiveness in managing hypertension through dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hypertension diet education program for public health nurses. Kostas, G.[2009]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Participant perspectives on the impact of receiving medically tailored meals on post-hospitalization. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Comprehensive nutrition plan improves cardiovascular risk factors in essential hypertension. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary compliance and cardiovascular risk reduction with a prepared meal plan compared with a self-selected diet. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A hypertension diet education program for public health nurses. [2009]