Delivering Health: Addressing Diabetes and Food Insecurity

NCT ID: NCT04831216

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-24
• Study Completion Date: 2023-07-13

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.

Detailed Description

Background and Rationale

Decades of increasing incidence of type 2 diabetes (T2D) present a multifaceted challenge to the health of a growing number of Americans, affecting their diets and how they live life. Approximately 30 million (~9%) of all people in the US have T2D, and this number is expected to continue to rise. At the same time, 15 million (11.8%) US households experience food insecurity, which is associated with risk for T2D and other chronic diseases. Both T2D and food insecurity are even more prevalent in Arkansas, with rates of T2D and food insecurity at 12.2% and 17.3%, respectively.

Approximately 46 million Americans per year turn to food pantries and related programs to help meet household nutritional needs. However, food pantries are not a long-term solution to improve health for food insecure people with T2D. Most food pantries do not provide food of sufficient dietary quality to support a healthy lifestyle.

Diabetes self-management education (DSME) is an approach with documented efficacy in helping people manage T2D. DSME supports informed decision-making, encourages goal setting and problem solving, and improves self-care behaviors. Recent studies have shown promise for DSME among food pantry clients with T2D. However, studies have suffered from problems with attendance and retention.

We designed a study to develop and evaluate the efficacy of a plain-language DSME curriculum to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D. We home-delivered this curriculum along with T2D-appropriate healthy food boxes to mitigate difficulties associated with access to healthy food and attendance at DSME sessions outside of the home. We hypothesized that this approach will lead to improvements in participants' glycemic control, diet quality, and other outcomes.

Study Population Up to 110 study participants will be recruited from food pantries located in Benton and Washington Counties in northwest Arkansas.

Inclusion Criteria:

• 18 years of age or older
• Food insecure (confirmed with adapted 10-item screener)
• HbA1c levels of ≥7%

Exclusion Criteria:

• 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

Study Design and Procedures For each participant, participation took place over 22 weeks (Weeks 1-4: Pre-intervention data collection; Weeks 5-16: Intervention; Weeks 17-22: Post-intervention data collection). Data collection took place at pre-intervention and post-intervention for each participant. At enrollment (i.e., pre-intervention) and one week after the 12th food box delivery (i.e. post-intervention), participants provided data on glycemic control (measured by HbA1c), physical activity, body mass index (BMI), T2D self-management behaviors, T2D knowledge, T2D self-efficacy, and food security. To enhance the study's significance in characterizing the diet patterns and fruit and vegetable consumption of low-income food insecure people with T2D, we collected extensive diet quality data measures pre-intervention and post-intervention.

Data Analysis To examine the intervention's effect on the primary outcomes of glycemic control as measured by HbA1c and diet quality as measured by Healthy Eating Index-2015 (HEI) scores, we used mixed effects regression models for repeated measures. These analyses focused on testing for a statistically significant difference between pre-intervention versus post-intervention measures. Analyses included relevant covariates such as sex or age.

Conditions

Food Insecurity; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

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.

Group Type: EXPERIMENTAL

Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

Intervention Type: 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.

Interventions

Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Food insecure (confirmed with adapted 10-item screener)
• HbA1c levels of ≥7%

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krista N Langston, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

260304

Identifier Type: -

Identifier Source: org_study_id