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

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how medically tailored meals (MTM) might help people with type 2 diabetes and high blood pressure improve heart health. Researchers will study two groups: those who qualify for these meals and those who do not. Some participants will receive only the meals, while others will also get extra support, such as heart health classes, cooking demonstrations, and healthy recipes. The trial seeks participants with type 2 diabetes and high blood pressure, especially those who struggle with these conditions daily. As an unphased trial, this study offers a unique opportunity to explore innovative support methods for managing health.

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 prior data suggests that medically tailored meals and cardiovascular health education are safe for individuals with type 2 diabetes and high blood pressure?

Research has shown that medically tailored meals (MTMs) are generally safe and well-tolerated. One study found that MTMs improved health for people with serious illnesses. Another review demonstrated that MTMs can help reduce hospital visits, suggesting they are safe to use alongside regular medical care. These meals are specially designed to meet each person's nutritional needs, aiding in the management of conditions like diabetes and high blood pressure.

Regarding the heart health program, studies indicate it can improve heart health by influencing diet and activity levels. This program emphasizes lifestyle changes to help manage blood pressure and cholesterol, which are crucial for heart health. No major safety concerns have been reported with these educational programs. They aim to support healthier lifestyles without involving medical procedures or medications.

In summary, both medically tailored meals and the heart health program appear safe and helpful for managing health conditions without significant risks or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about medically tailored meals (MTMs) and the comprehensive health promotion program because they offer a personalized approach to managing high blood pressure, especially for those with type 2 diabetes. Unlike standard treatments, which often rely on medication, this intervention combines nutrition and lifestyle changes, providing home-delivered meals tailored to individual health needs and nutritional counseling by dietitians. The program also includes culturally and contextually tailored sessions focusing on lifestyle change, goal setting, and social support, which are not typically part of standard care. This holistic approach addresses not just the physical but also the social determinants of health, potentially offering a more sustainable and effective way to manage high blood pressure.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research shows that meals specifically designed for medical needs, known as medically tailored meals (MTMs), can improve health for people with serious illnesses. Studies have found that MTMs help manage conditions like diabetes and high blood pressure by providing meals that meet specific nutritional needs. These meals often lead to better blood pressure and improved diabetes control. Nutritional counseling, included with MTMs, supports healthy lifestyle changes.

In this trial, participants in various arms will receive MTMs and nutritional counseling. Some arms will also feature a culturally and contextually tailored cardiovascular health promotion program. Educational programs about heart health have effectively increased knowledge and helped people manage heart-related issues. These programs often encourage healthier lifestyle choices, leading to better heart health and lower blood pressure. Combining MTMs with heart health education in this trial may enhance both participation and success in managing diabetes and high blood pressure. ^{1 4 6 7 8}

Who Is on the Research Team?

Nour Makarem, PhD, FAHA

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4109043/

The Effect of Educational Programs on Hypertension ... The results of the current study indicated that the educational programs were effective in increasing knowledge, improving self-management, and controlling ...

2. ahajournals.org ahajournals.org/doi/10.1161/01.cir.0000141117.85384.64

Cardiovascular Health Promotion in the Schools | Circulation Schools provide many opportunities for shaping dietary and physical activity behaviors, which influence CVD risk factors such as blood lipids, blood pressure, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1751991825001937

A structured education program for improving ... Structured community-based diabetes education programs may improve cardiometabolic outcomes, yet objective evidence remains limited.

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2807849

School-Based Cardiovascular Health Promotion in ... This randomized clinical trial compares the use of school-based health promotion interventions in adolescents in 2- vs 4-year programs, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5774278/

Impact of educational interventions on primary prevention ... Most studies reported significant positive effects of the health education interventions on cardiovascular risk factors, mainly on lipid profile, blood pressure ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8020477/

Results of a prospective cardiovascular disease prevention ... The Cardiovascular Health Program (CHP) Registry is a 12-month, prospective study of therapeutic lifestyle change (TLC).

7. heart.org heart.org/-/media/Files/About-Us/Policy-Research/Prevention-Nutrition/state-cardiovascular-programs-UCM_498682.pdf

State Cardiovascular Health Programs: A Guide to Core ... Develop and implement medication optimization programs to manage blood pressure, high cholesterol and cardiovascular disease and prevent heart attack and stroke ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.123.321998

Life Course Cardiovascular Health: Risk Factors ... CVH measured at any point in life is strongly predictive of future cardiovascular disease, dementia, cancer, and mortality as well as a variety of other health ...