Delivering Health: Addressing Diabetes and Food Insecurity

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Food Insecurity, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Type 2 Diabetes Appropriate Food Boxes + Diabetes Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will be assigned to a single intervention arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Type 2 Diabetes Appropriate Food Boxes + Diabetes Education<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food insecurity, Type 2 diabetes mellitus, Nutrition, Food delivery