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OpenTrials
Completed

NCT Number: NCT04876053

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAMS - North Central, Batesville, Arkansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Healthy Food Delivery Intervention

Behavioral

Each weekly food box will include ~9,000 calories of food, equivalent to the amount the average household receives prorated per week from an average Arkansas food pantry. The boxes will be designed by a registered dietitian. The boxes will follow ADA's Create Your Plate method consistent with the meal pattern promoted in the American College of Physicians (ACP) DSMES. The foods will also reflect Feeding America's Detailed Foods to Encourage framework, developed by nutrition experts and food bank staff to represent USDA dietary guidelines with healthy food that can be made available by food banks.

Primary outcomes

  1. HbA1c

    Time frame: Baseline to immediate post-intervention (approx. 18 weeks)

    Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 6, 2021
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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