Delivering Health: Addressing Diabetes and Food Insecurity

Sponsor

University of Arkansas (Other)

Overall Status

Recruiting

CT.gov ID

NCT04831216

Collaborator

(none)

100

Enrollment

Location

Arm

35.2

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Food Insecurity Diabetes Mellitus, Type 2	Behavioral: Type 2 Diabetes Appropriate Food Boxes + Diabetes Education	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All participants will be assigned to a single intervention arm.All participants will be assigned to a single intervention arm.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food Insecurity

Actual Study Start Date :

Aug 24, 2021

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

Outcome Measures

Primary Outcome Measures

Hemoglobin A1c (HbA1c), % [Baseline; immediate post-intervention (approx. 20 weeks)]
A Siemens analyzer will be utilized to calculate HbA1c (%) for each participant at every time point. Changes in the primary outcome measure will be assessed from baseline to each follow-up time point.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Screen positive for food insecurity
18 years of age or older
Type 2 diabetes, confirmed by HbA1c equal to or greater than 7.0%

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
Only one adult per household will be enrolled
Individuals under 18 years old are excluded because the intervention is designed for adults with T2D
Pregnant