Back to resultsDelivering Health: Addressing Diabetes and Food Insecurity
Primary Purpose
Food Insecurity, Diabetes Mellitus, Type 2
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Type 2 Diabetes Appropriate Food Boxes + Diabetes Education
Sponsored by
About this trial
This is an interventional supportive care trial for Food Insecurity focused on measuring Food insecurity, Type 2 diabetes mellitus, Nutrition, Food delivery
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical Sciences Northwest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Type 2 Diabetes Appropriate Food Boxes + Diabetes Education
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04831216
Brief Title
Delivering Health: Addressing Diabetes and Food Insecurity
Official Title
Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food Insecurity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Insecurity, Diabetes Mellitus, Type 2
Keywords
Food insecurity, Type 2 diabetes mellitus, Nutrition, Food delivery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will be assigned to a single intervention arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Type 2 Diabetes Appropriate Food Boxes + Diabetes Education
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Type 2 Diabetes Appropriate Food Boxes + Diabetes Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c), %
Description
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.
Time Frame
Baseline; immediate post-intervention (approx. 20 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R Long, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences Northwest
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Delivering Health: Addressing Diabetes and Food Insecurity
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