Home Food Delivery for Diabetes Management in Patients of Rural Clinics

NCT04876053 | Completed

• 1 other identifier: 261074
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 4

Brief 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. 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. 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. 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

Diabetes Mellitus, Type 2; Diet, Healthy

Keywords

Food Insecurity

Outcome Measures

Primary Outcomes (1)

• HbA1c

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

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

Study Arms (2)

Standard Care

NO INTERVENTION

Healthy Food Delivery Intervention

EXPERIMENTAL

9000 calorie / week food box

Behavioral: Healthy Food Delivery Intervention

Interventions

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.

Healthy Food Delivery Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (4)

UAMS - North Central

Batesville, Arkansas, 72501, United States

Location

UAMS - East

Helena, Arkansas, 72390, United States

Location

UAMS - Northeast

Jonesboro, Arkansas, 72401, United States

Location

UAMS - South

Magnolia, Arkansas, 71753, United States

Location

Related Publications (1)

• Short E, Selig JP, Felix HC, Painter J, McElfish PA, Rowland B, Ammerman AS, Bounds K, Henske J, Hudson JS, Li J, Young SG, Long CR. Healthy food delivery for type 2 diabetes management in rural clinics' patients: A comparative effectiveness randomized controlled trial protocol. Contemp Clin Trials. 2024 May;140:107491. doi: 10.1016/j.cct.2024.107491. Epub 2024 Mar 6.

  PMID: 38458560 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christopher R Long, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 6, 2021
• Study Start: October 22, 2021
• Primary Completion: February 6, 2025
• Study Completion: December 18, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)