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NCT04831216 Clinical Trial

Delivering Health: Addressing Diabetes and Food Insecurity

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04831216
Other study ID # 260304
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 24, 2021
Est. completion date July 31, 2024

Study information
Verified date March 2024
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Arkansas for Medical Sciences Northwest Fayetteville Arkansas

Sponsors (1)
Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin A1c (HbA1c), % 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. Baseline; immediate post-intervention (approx. 20 weeks)
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