Delivering Health: Addressing Diabetes and Food Insecurity

NCT04831216 | Completed Results

• 1 other identifier: 260304
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study was to develop, implement, and evaluate the effectiveness of an intervention to use home-delivery of Type 2 diabetes (T2D)-appropriate food boxes with plain language adapted education materials to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D in northwest Arkansas.

Conditions

Diabetes Mellitus, Type 2; Food Insecurity

Keywords

Food insecurity; Type 2 diabetes mellitus; Nutrition; Food delivery

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c), %

  A Siemens analyzer was utilized to measure HbA1c (%) via finger stick blood collection.

  Baseline; immediate post-intervention (approx. 20 weeks)

Secondary Outcomes (19)

• Diet Quality

  Baseline; immediate post-intervention (approx. 20 weeks)

• Diet Quality (2)

  Baseline; immediate post-intervention (approx. 20 weeks)

• Body Mass Index (BMI)

  Baseline; immediate post-intervention (approx. 20 weeks)

• Chronic Diseases

  Baseline; immediate post-intervention (approx. 20 weeks)

• Type 2 Diabetes Self-Management Self-Efficacy

  Baseline; immediate post-intervention (approx. 20 weeks)

Study Arms (1)

Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

EXPERIMENTAL

All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials.

Behavioral: Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

Interventions

Type 2 Diabetes Appropriate Food Boxes + Diabetes Education BEHAVIORAL

All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials.

Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

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
• Food insecure (confirmed with adapted 10-item screener)
• HbA1c levels of ≥7%

You may not qualify if:

• Conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region
• Pregnant
• Only one adult per household will be enrolled

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, 72703, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Krista Langston
• Organization: University of Arkansas for Medical Sciences

KNLangston@uams.edu

479-713-8000

Study Officials

• Krista N Langston, MBA

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be assigned to a single intervention arm.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: August 24, 2021
• Primary Completion: June 15, 2023
• Study Completion: July 13, 2023
• Last Updated: January 16, 2026
• Results First Posted: April 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)