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Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Nutrition Education Classes
Healthy Food Security Resource
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Dx type 2 diabetes; American Indian or Alaska Native; fluent in English Exclusion Criteria: Planned move within the study period

Sites / Locations

  • Oklahoma City Indian ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

What Can I Eat Diabetes Nutrition Education Classes Only

What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource

Healthy Food Security Resource Only

Arm Description

Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline).

Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline). Additionally, patients will receive a $30.00 healthy food resource weekly for 12 weeks.

Patients will receive a $30.00 healthy food resource weekly for 12 weeks.

Outcomes

Primary Outcome Measures

Hemoglobin A1c
Participant HbA1c will be collected by point of care fingerstick or electronic medical record

Secondary Outcome Measures

Blood pressure
Participant systolic and diastolic blood pressure measurements collected by arm cuff automated BP read or electronic medical record
Body weight
Body weight will be measured or collected via electronic medical record
Food insecurity
Self reported survey: Food insecurity measured by 18 item USDA food security module
Diabetes distress
Self reported survey: Participant diabetes distress measured by Problem Areas in Diabetes Scale (PAID-5)
Economic Quality of Life
Self reported survey: 10 item measure assessing the economic quality of life
Perceived Diabetes Self Management Scale (PDSMS)
Self reported survey: 8 item measure assessing perceived diabetes self management scale
What Can I Eat? Impact Survey
Self reported survey: 30 item measure assessing knowledge, self efficacy, and behavior from participating in "What Can I Eat?" diabetes nutrition education
Dietary intake - 24 hour recall
Dietitian proctored 24 hour dietary recall using ASA24

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
Colorado State University
Collaborators
American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver, Washington State University, Oklahoma City Indian Clinic, Gretchen Swanson Center for Nutrition, University of North Carolina, Chapel Hill, University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT06077162
Brief Title
Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D
Official Title
Diabetes Nutrition Education (What Can I Eat? [WCIE]) and Healthy Food Resource for American Indians and Alaska Natives With T2D
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
November 15, 2025 (Anticipated)
Study Completion Date
November 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University
Collaborators
American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver, Washington State University, Oklahoma City Indian Clinic, Gretchen Swanson Center for Nutrition, University of North Carolina, Chapel Hill, University of California, Irvine

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
Healthy nutrition habits are key to managing type 2 diabetes (T2D). However, American Indian and Alaska Natives (AI/ANs) often lack access to culturally relevant nutrition education and they disproportionately experience food insecurity. Food insecurity, defined as lack of consistent access to enough food for an active, healthy life, negatively impacts one's ability to engage in diabetes self-management and care. The purpose of this study is to evaluate if diabetes nutrition education and an added food security resource, such as farmers market vouchers for fruits and vegetables, can improve diabetes self-management for AI/ANs with T2D. Researchers will work with collaborators at the Oklahoma City Indian Clinic in Oklahoma City, OK, and an American Indian community advisory board (CAB) throughout the study to ensure the nutrition education and food security resources are designed to meet the needs of the community and clinic. With the guidance of the CAB, researchers will recruit adults with T2D to participate in a 3-month intervention. Participants will be randomized into one of 3 groups. Some people will have diabetes nutrition education and the food security resource, some will have only the diabetes nutrition education, and some will receive only the food security resource. Outcomes such as food security status and clinical diabetes health indicators will be measured at 5 timepoints. This intervention is significant to diabetes because AI/ANs experience diabetes health disparities and the combination of diabetes nutrition education plus an added food security resource could help decrease T2D complications and improve quality of life for AI/ANs.
Detailed Description
Background: Healthy nutrition is key to T2D self-care and management. Culturally relevant nutrition education for American Indian and Alaska Natives (AI/Ans) is limited, contributing to diabetes health disparities, and disproportionate rates of food insecurity exacerbates these disparities. Hypothesis: AI/ANs with T2D who receive both culturally relevant diabetes nutrition education and food security resources will have more improved outcomes (e.g., dietary intake, HbA1c) than AI/ANs with T2D who receive only diabetes nutrition education or a food security resource. Supporting Rationale: Nutrition education improves T2D outcomes and reducing food insecurity can decrease diabetes health disparities. Specific Aims: Aim #1: Engage an AI/AN community advisory board to support rigorous and equitable community based participatory research; Aim #2: Implement and evaluate a diabetes nutrition education and food security resource intervention in collaboration with the Oklahoma City Indian Clinic in Oklahoma City, OK. Research Design: Three arm randomized controlled trial with: intervention group (diabetes nutrition education + food security resource); diabetes nutrition education group only; food security resource group only. Three month intervention with diabetes nutrition education and food security resource with 5 data collection timepoints: baseline, 1, 3, 6, 9 months. Outcomes include: HbA1c, blood pressure, dietary intake, diabetes distress, and food security. Relevance to a cure, prevention and/or treatment of diabetes: Treatment of T2D among AI/ANs requires multi-level approaches to decrease health disparities related to social determinants of health such as lack of access to healthful foods. Providing both nutrition education and a food security resource could synergistically improve T2D self-management for AI/ANs

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 arm RCT (nutrition education classes only, nutrition education classes + healthy food resource, healthy food resource only) - randomized at pt level, no stratification
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
What Can I Eat Diabetes Nutrition Education Classes Only
Arm Type
Experimental
Arm Description
Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline).
Arm Title
What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource
Arm Type
Experimental
Arm Description
Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline). Additionally, patients will receive a $30.00 healthy food resource weekly for 12 weeks.
Arm Title
Healthy Food Security Resource Only
Arm Type
Experimental
Arm Description
Patients will receive a $30.00 healthy food resource weekly for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Diabetes Nutrition Education Classes
Intervention Description
Diabetes nutrition education offered by registered dietitian in group-based classes.
Intervention Type
Other
Intervention Name(s)
Healthy Food Security Resource
Intervention Description
Participants offered security resource which is a $30.00 Aldi (grocery store) gift card provided weekly for 12 weeks.
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Participant HbA1c will be collected by point of care fingerstick or electronic medical record
Time Frame
0, 3, 6, 9 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Participant systolic and diastolic blood pressure measurements collected by arm cuff automated BP read or electronic medical record
Time Frame
0, 3, 6, 9 months
Title
Body weight
Description
Body weight will be measured or collected via electronic medical record
Time Frame
0, 3, 6, 9 months
Title
Food insecurity
Description
Self reported survey: Food insecurity measured by 18 item USDA food security module
Time Frame
0, 3, 6, 9 months
Title
Diabetes distress
Description
Self reported survey: Participant diabetes distress measured by Problem Areas in Diabetes Scale (PAID-5)
Time Frame
0, 3, 6, 9 months
Title
Economic Quality of Life
Description
Self reported survey: 10 item measure assessing the economic quality of life
Time Frame
0, 3, 6, 9 months
Title
Perceived Diabetes Self Management Scale (PDSMS)
Description
Self reported survey: 8 item measure assessing perceived diabetes self management scale
Time Frame
0, 3, 6, 9 months
Title
What Can I Eat? Impact Survey
Description
Self reported survey: 30 item measure assessing knowledge, self efficacy, and behavior from participating in "What Can I Eat?" diabetes nutrition education
Time Frame
0, 3, 6, 9 months
Title
Dietary intake - 24 hour recall
Description
Dietitian proctored 24 hour dietary recall using ASA24
Time Frame
0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dx type 2 diabetes; American Indian or Alaska Native; fluent in English Exclusion Criteria: Planned move within the study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah A Stotz, PhD
Phone
858-232-3545
Email
sarah.stotz@colostate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Stotz, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma City Indian Clinic
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah A Stotz, PhD
Phone
858-232-3545
Email
sarah.stotz@colostate.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Tribes are sovereign Indian Nations that have a unique government-to-government relationship with the Federal government. Many discussions, publications, and treatises have addressed how this relationship affects the ownership and sharing of data. The growing consensus on the part of Tribal communities is that the Indian Nations have an inherent right to at least an equal say in the fate of raw data. More recently, these same rights have been exercised by community organizations and agencies serving Native peoples. Decisions about sharing of data cannot be made without full discussion and agreement by the participating tribes or agencies. Each Tribe involved must approve all provisions laid down in such policies prior to the release of data to any outside investigator or entity. This includes seeking approval for abstracts and manuscripts to be presented and submitted to academic or scientific conferences and journals.

Learn more about this trial

Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

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