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NCT06550297 · ClinicalTrials.gov registry record · NA
Medically Tailored Meals for Cardiovascular Health
A NA study of Blood Pressure and Diet, Healthy, sponsored by Columbia University.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT06550297: Recruiting NA study of Blood Pressure and Diet, Healthy, sponsored by Columbia University.
NCT06550297 is a NA study of Blood Pressure and Diet, Healthy that is actively recruiting participants, run by Columbia University. The registered enrollment target is 160 participants, below the 285-participant average among 101 other Blood Pressure trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06550297, a NA study of Blood Pressure and Diet, Healthy, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study 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, 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 fresh produce, 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 to high blood pressure who currently qualify for MTM programs? 2. Is the MTM program coupled with the cardiovascular health curriculum effective for improving healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated to high blood pressure who do not currently qualify 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, 60 participants with type 2 diabetes and elevated to high 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 to high blood pressure who do not currently qualify for MTM programs (due to not having advanced disease with complications) 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
Primary Outcome
The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 8 months will be calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Conditions Studied
Interventions
- BEHAVIORAL Medically Tailored Meals and Nutritional Counseling
- BEHAVIORAL Cardiovascular Health Promotion Educational Program
Study Locations (1)
New York
- Columbia University Mailman School of Public Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2024-08-28 |
| Est. Completion | 2026-06 |
| Phase | NA |
What NCT06550297 shows while recruiting
NCT06550297 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 285-participant average among 101 other Blood Pressure trials with a reported enrollment target (44% lower).
The record links to 3 conditions, with Blood Pressure appearing as the primary indexed condition, and to 2 interventions - of which Medically Tailored Meals and Nutritional Counseling is the first listed.
NCT06550297 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06550297 about?
NCT06550297 is a clinical study titled "Medically Tailored Meals for Cardiovascular Health". 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, focusing on economically disadvantaged New York City neighborhoods with a dispara...
What is the current status of trial NCT06550297?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2024-08-28. Estimated completion is 2026-06.
What conditions does trial NCT06550297 study?
This clinical trial studies the following conditions: Blood Pressure, Diet, Healthy, HbA1c.
What interventions are being tested in trial NCT06550297?
The interventions under investigation include: Medically Tailored Meals and Nutritional Counseling (BEHAVIORAL), Cardiovascular Health Promotion Educational Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT06550297?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06550297 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06550297's enrollment target sits among peer trials
160 24th of 101 higher than 76 of 101 other Blood Pressure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Blood Pressure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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