Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Public ClinicalTrials.gov record NCT04876053. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04876053
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 416 participants
Conditions and interventions
Conditions
Interventions
- Healthy Food Delivery Intervention Behavioral
- CDCES Consultation Only Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 22, 2021 (Actual)
- Primary completion
- Feb 6, 2025 (Actual)
- Completion
- Dec 18, 2025 (Actual)
- Last update posted
- Sep 16, 2026
2021 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 1
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAMS - North Central | Batesville | Arkansas | 72501 | — |
| Pocahontas Medical Center | Corning | Arkansas | 72422 | — |
| Washington Regional Medical Center | Eureka Springs | Arkansas | 72632 | — |
| UAMS - Northwest | Fayetteville | Arkansas | 72703 | — |
| Washington Regional Medical Center | Fayetteville | Arkansas | 72703 | — |
| UAMS - West | Fort Smith | Arkansas | 72901 | — |
| Washington Regional Medical Center | Harrison | Arkansas | 72601 | — |
| UAMS - East | Helena | Arkansas | 72390 | — |
| UAMS - Northeast | Jonesboro | Arkansas | 72401 | — |
| UAMS - South | Magnolia | Arkansas | 71753 | — |
| Lee County Cooperative Clinic | Marianna | Arkansas | 72360 | — |
| Boston Mountain Rural Health Center | Marshall | Arkansas | 72650 | — |
| Pocahontas Medical Clinic | Pocahontas | Arkansas | 72455 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04876053, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04876053 live on ClinicalTrials.gov.