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NCT07316569 · ClinicalTrials.gov registry record · NA
The Healthy Eating and Active Living to Reverse Diabetes Pilot Study
A NA study, sponsored by University of Tennessee.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT07316569 is a NA study that has completed, run by University of Tennessee. The registered enrollment target is 35 participants.
The verdict
NCT07316569, a NA study, has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
The HEAL Diabetes Program is a multicomponent intensive plant-forward healthy eating program designed to reverse diabetes. Several recent studies, most notably the Diabetes UK-funded Diabetes Remission Clinical Trial (DiRECT) in England and Scotland, have demonstrated that intensive programs for weight loss and weight loss maintenance can lead to long-term remission of diabetes for as many as half of patients with early Type 2 (adult-onset) diabetes. Furthermore, the U.S. Preventive Services Task Force has recommended that all patients with obesity and at highest risk for diabetes be referred to such intensive multicomponent behavioral weight loss interventions, but no such programs are available for people living in the low-income and underserved areas of Memphis. This effort will pilot an innovative, culturally tailored, and intensive healthy eating program designed to reverse diabetes based in the UTHSC Neighborhood Health Hub located in low-income neighborhoods to demonstrate that this approach will work in Memphis to improve and extend people's lives. The HEAL Diabetes Pilot Program will: a) engage and retain a minimum of 30 patients with Type 2 diabetes and obesity to participate in the program as well as 30 additional "control" patients who will receive routine care, and b) assess patient outcomes including weight loss and rates of diabetes remission using average blood sugar (hemoglobin A1c) over a six-month period. The healthy eating and active living to reverse diabetes (HEAL Diabetes) is a pilot study that aims to evaluate the feasibility, effectiveness, and operational and financial sustainability of a multicomponent health coach-supported nutrition intervention in a predominately African American population in Memphis, Tennessee. The investigators aim to assess study feasibility by evaluating recruitment, sample characteristics, intervention acceptability and procedural suitability. The investigators also aim to quantify and compare the treatment and co
Interventions
- BEHAVIORAL Intensive Multicomponent Healthy Eating and Weight Loss Intervention
- BEHAVIORAL Enhanced Usual Diabetes Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-10-11 |
| Est. Completion | 2025-08-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07316569
The ClinicalTrials.gov registry entry for NCT07316569 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Tennessee, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intensive Multicomponent Healthy Eating and Weight Loss Intervention is the first listed.
NCT07316569 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07316569 about?
NCT07316569 is a clinical study titled "The Healthy Eating and Active Living to Reverse Diabetes Pilot Study". The HEAL Diabetes Program is a multicomponent intensive plant-forward healthy eating program designed to reverse diabetes. Several recent studies, most notably the Diabetes UK-funded Diabetes Remission Clinical Trial (DiRECT) in England and Scotland, have demonstrated that intensive programs for wei...
What is the current status of trial NCT07316569?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2023-10-11. Estimated completion is 2025-08-02.
What interventions are being tested in trial NCT07316569?
The interventions under investigation include: Intensive Multicomponent Healthy Eating and Weight Loss Intervention (BEHAVIORAL), Enhanced Usual Diabetes Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT07316569?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
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