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NCT04876053 · ClinicalTrials.gov registry record · NA
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
A NA study of Diabetes Mellitus, Type 2 and Diet, Healthy, sponsored by University of Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 415
- Enrollment target
- 4
- Study locations
NCT04876053 is a NA study of Diabetes Mellitus, Type 2 and Diet, Healthy that has completed, run by University of Arkansas. The registered enrollment target is 415 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 1 state.
The verdict
NCT04876053, a NA study of Diabetes Mellitus, Type 2 and Diet, Healthy, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 415 participants
- Enrollment target
- 4
- Study locations
Study Summary
Our long-term goal is to transform rural residents' management of T2DM. This study's objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural food insecure participants' difficulties associated with completing existing interventions. Our specific aims are: 1. Compare the effectiveness of the Healthy Food Delivery Intervention (HFDI) plus standard care and standard care alone to improve diabetes-related outcomes among rural food insecure patients with T2DM. Hypothesis: Compared with standard care alone, patients receiving the HFDI plus standard care will demonstrate improved: H1 glycemic control as measured by HbA1c; H2 cardio-metabolic risk factors: blood pressure, fasting glucose, fasting lipids, and BMI; H3 self-management: self-efficacy, adherence to self-management behaviors, and medication adherence; H4 patient-centered outcomes: diabetes-related distress, diabetes-related quality of life, and diabetes-related complications. 2. Compare the effectiveness of the HFDI plus standard care and standard care alone to improve diet quality among rural food insecure patients with T2DM. Hypothesis: Compared with standard care alone, patients receiving the HFDI plus standard care will demonstrate improved: H1 Healthy Eating Index 2015 (HEI-2015) scores; H2 fruit and vegetable consumption. 3. Compare cost-effectiveness to understand HFDI plus standard care costs in relationship to outcomes in relation to standard care alone. Hypothesis: The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained.
Conditions Studied
Interventions
- BEHAVIORAL Healthy Food Delivery Intervention
Study Locations (4)
Arkansas
- UAMS - North Central - Batesville
- UAMS - East - Helena
- UAMS - Northeast - Jonesboro
- UAMS - South - Magnolia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 415 participants |
| Start Date | 2021-10-22 |
| Est. Completion | 2025-12-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04876053
The ClinicalTrials.gov registry entry for NCT04876053 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 415 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (91% lower). The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which Healthy Food Delivery Intervention is the first listed.
NCT04876053 reports 4 study locations spanning 1 distinct geographic area - top geographies include Arkansas.
Frequently Asked Questions
What is clinical trial NCT04876053 about?
NCT04876053 is a clinical study titled "Home Food Delivery for Diabetes Management in Patients of Rural Clinics". Our long-term goal is to transform rural residents' management of T2DM. This study's objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural food insecure participants' difficulties associated with completing ...
What is the current status of trial NCT04876053?
This trial is currently completed. It is a NA study. The enrollment target is 415 participants. The study started on 2021-10-22. Estimated completion is 2025-12-18.
What conditions does trial NCT04876053 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diet, Healthy.
What interventions are being tested in trial NCT04876053?
The interventions under investigation include: Healthy Food Delivery Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04876053?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04876053 being conducted?
This trial has 4 study locations across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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