Medically tailored meals to improve cardiovascular health in underserved communities
Enhancing, Culturally Adapting, and Expanding Medically Tailored Meals Programs to Promote Cardiovascular Health Equity
This study is testing if specially designed meals and health education can help people with type 2 diabetes and high blood pressure in low-income neighborhoods eat better and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06550297 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of medically tailored meals (MTM) combined with a cardiovascular health curriculum in promoting healthy eating behaviors and improving clinical outcomes such as HbA1c and blood pressure among individuals with type 2 diabetes and hypertension. The study focuses on economically disadvantaged neighborhoods in New York City, aiming to enhance engagement and effectiveness of MTM programs. Participants will receive culturally relevant educational sessions, cooking demonstrations, and healthy ingredients to address food insecurity and chronic disease management.
Who should consider this trial
Good fit: Ideal candidates include individuals with type 2 diabetes and elevated blood pressure who qualify for medically tailored meal programs.
Not a fit: Patients with cancer, severe psychiatric disorders, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cardiovascular health outcomes for individuals with diabetes and hypertension in underserved communities.
How similar studies have performed: Other studies have shown promise in using food as medicine approaches, but this specific combination of MTM and cardiovascular education is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 7. 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) Inclusion Criteria: 1. Type 2 diabetes diagnosis (physician diagnosed or HbA1c greater than or equal to 6.5% or diabetes medication use) 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 physician diagnosis or hypertension medication use) 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 7. Health conditions that could prevent safe participation or impact study outcomes (e.g., substance use disorder, dialysis, neurodegenerative conditions)
Where this trial is running
New York, New York
- Columbia University Mailman School of Public Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Nour Makarem, PhD, FAHA — Columbia University
- Study coordinator: Research Project Coordinator
- Email: FIM4CVH@cumc.columbia.edu
- Phone: 212-305-3317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.