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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04828785
The ClinicalTrials.gov registry entry for NCT04828785 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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