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Medically Tailored Meals for Cardiovascular Health
NCT06550297 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06550297
The ClinicalTrials.gov registry entry for NCT06550297 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 875 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06550297 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06550297?
This trial is sponsored by Columbia University, which has 875 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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