Home Food Delivery for Diabetes Management in Patients of Rural Clinics

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Diet, Healthy

In brief

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.

Key facts

Study ID

NCT04876053

Run by

University of Arkansas

People needed

415

Starts

2021-10-22

Expected to finish

2025-12-18

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age or older
• report food insecurity
• report T2D (confirmed by having an HbA1c equal to or greater than 6.5 at initial data collection immediately following consent)
• Speak English or Spanish
• Currently lives at a rural address

You may not qualify if…

• 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
• Pregnant

Where it is running

• UAMS - North Central — Batesville, Arkansas, United States
• UAMS - East — Helena, Arkansas, United States
• UAMS - Northeast — Jonesboro, Arkansas, United States
• UAMS - South — Magnolia, Arkansas, United States

Full record on ClinicalTrials.gov

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