NCT04876053Completed
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
The goal of this randomized controlled trial was to determine the effectiveness of a Healthy Food Delivery Intervention (HFDI) on the outcomes of rural food insecure patients with type 2 diabetes mellitus (T2DM). Our specific aims were to: 1. Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diabetes-related outcomes among rural food insecure patients with T2DM. Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved: H1- glycemic control as measured by HbA1c; H2- cardio-metabolic risk factors: body mass index (BMI), blood pressure, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, blood glucose; H3- diabetes management self-efficacy; H4- diabetes-related distress. 2. Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diet quality among rural food insecure patients with T2DM. Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved: H1- Healthy Eating Index 2015 (HEI-2015) scores; H2- fruit and vegetable consumption as measured by Veggie Meter scores. 3. Compare cost-effectiveness to understand HFDI costs in relationship to outcomes in relation to CDCES Consultation Only. Hypothesis: The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 416 (actual)
- First submitted
- 30 Apr 2021
- Start date
- 22 Oct 2021
- Primary completion date
- 6 Feb 2025
- Lead sponsor
- University of Arkansas
- Diseases
- Type 2 diabetes
- NCT number
- NCT04876053
What you commit to
- Study type: Interventional
- Participants enrolled: 416
- From 22 Oct 2021 to the primary completion date, 6 Feb 2025
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region
Other
- Pregnant
- Only one adult with T2DM per household will be enrolled
Who the study is looking for
- 18 years of age or older
- HbA1c equal to or greater than 6.5
- Speak English or Spanish
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAMS - North Central Coordinator of this site? Confirm its status | Batesville | United States | Unknown status |
| Pocahontas Medical Center Coordinator of this site? Confirm its status | Corning | United States | Unknown status |
| Washington Regional Medical Center Coordinator of this site? Confirm its status | Eureka Springs | United States | Unknown status |
| UAMS - Northwest Coordinator of this site? Confirm its status | Fayetteville | United States | Unknown status |
| Washington Regional Medical Center Coordinator of this site? Confirm its status | Fayetteville | United States | Unknown status |
| UAMS - West Coordinator of this site? Confirm its status | Fort Smith | United States | Unknown status |
| Washington Regional Medical Center Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| UAMS - East Coordinator of this site? Confirm its status | Helena | United States | Unknown status |
| UAMS - Northeast Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| UAMS - South Coordinator of this site? Confirm its status | Magnolia | United States | Unknown status |
| Lee County Cooperative Clinic Coordinator of this site? Confirm its status | Marianna | United States | Unknown status |
| Boston Mountain Rural Health Center Coordinator of this site? Confirm its status | Marshall | United States | Unknown status |
| Pocahontas Medical Clinic Coordinator of this site? Confirm its status | Pocahontas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.