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NCT04828785 · ClinicalTrials.gov registry record · NA
Food As MedicinE for Diabetes
A NA study of Diabetes Mellitus, Type 2, sponsored by University of North Carolina, Chapel Hill.
- Active
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04828785: Active NA study of Diabetes Mellitus, Type 2, sponsored by University of North Carolina, Chapel Hill.
NCT04828785 is a NA study of Diabetes Mellitus, Type 2 that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 200 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04828785, a NA study of Diabetes Mellitus, Type 2, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be established, given the nature of the population served by MTM, it is important to design the study to enhance the external validity/generalizability of the findings as much as possible. The investigators will recruit 200 participants from the referral list of Community Servings, a Boston-based MTM provider, and randomly assign them to MTM (N=100) or usual care + monthly food subsidy (N=100). MTM intervention will consist of 6 months of weekly delivery of 10 ready-to-eat meals (approximately half an individual's weekly food intake), along with telephone-based lifestyle intervention that prepares participants for the post-treatment period. The usual care + food subsidy recipients will receive usual care along with 6 months of a $40/month food subsidy.
Primary Outcome
Hemoglobin A1c Level
Conditions Studied
Interventions
- OTHER MTM
- OTHER Food Subsidy
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-07-02 |
| Est. Completion | 2026-03 |
| Phase | NA |
What the registry record for NCT04828785 still lists
NCT04828785 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which MTM is the first listed.
NCT04828785 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04828785 about?
NCT04828785 is a clinical study titled "Food As MedicinE for Diabetes". The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be establ...
What is the current status of trial NCT04828785?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2021-07-02. Estimated completion is 2026-03.
What conditions does trial NCT04828785 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT04828785?
The interventions under investigation include: MTM (OTHER), Food Subsidy (OTHER).
Who is sponsoring clinical trial NCT04828785?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04828785 being conducted?
This trial has 1 study location across North Carolina. 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 NCT04828785's enrollment target sits among peer trials
200 150th of 348 higher than 196 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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.
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