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Diabetes Nutrition Education for American Indian and Alaska Native Communities

Primary Purpose

Type 2 Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
American Indian and Alaska Native What Can I Eat?
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • AI/AN status (self-reported)
  • age > 18 years
  • fluent in English
  • a current diagnosis of T2DM.

Exclusion Criteria:

  • a major medical issue that may interfere with participation (e.g., prior cardio- or cerebrovascular disease including a recent myocardial infarction or major stroke; cancer not in remission; dialysis; active alcohol and/or substance abuse.)
  • a planned move from the area within the 3 to 6 month data collection time period that would not allow completion of all the study visits

Sites / Locations

  • Lakeport Tribal Health Consortium
  • Cherokee Indian Hospital
  • Indian Health Care Resource Center of Tulsa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Intervention

Wait list intervention

Arm Description

Participants receive diabetes nutrition education classes immediately.

Participants wait listed (control) for 3 months and then receive the diabetes nutrition education classes.

Outcomes

Primary Outcome Measures

Evaluate diabetes nutrition education program impact on HgA1C
Participants will have 2 A1C checks for Immediate intervention and 3 for wait list control. Immediate will have A1C tested at baseline and after the 5th class (at 3 months from baseline). Wait list will have A1C checked baseline, immediately before class #1 (3 months after baseline) and after class #5 (6 months after baseline). A1C will be checked per standard of care at the clinical site
Evaluate diabetes nutrition education program impact on blood pressure
Participants will have 3 BP checks for Immediate intervention and 5 for wait list control. Immediate will have BP tested at baseline, after the 4th class, and after the 5th class (at 3 months from baseline). Wait list will have BP checked baseline, immediately before class #1 (3 months after baseline), 1 month after baseline, after class #4, and after class #5 (6 months after baseline). Blood pressure will be checked per standard of care at the clinical site.
Evaluate diabetes nutrition education program impact on weight
Participants will have 3 weight checks for Immediate intervention and 5 for wait list control. Immediate will have weight tested at baseline, after the 4th class, and after the 5th class (at 3 months from baseline). Wait list will have weight checked baseline, at one month of wait list, immediately before class #1 (3 months after baseline), after class #4, and after class #5 (6 months after baseline). Weight will be checked per standard of care at the clinical site.
Evaluate diabetes nutrition education program impact on eating behavior
Participants will take a self-reported survey measuring their dietary habits using a food frequency table at several timepoints. Immediate intervention participants will take the survey 3 times (baseline, after class 4, after class 5). Wait list control participants will take the survey 5 times (baseline, at 1 month after baseline wait list, immediately before class #1, after class #4, after class #5)
Evaluate diabetes nutrition education program impact on nutrition knowledge
Participants will take a self-reported survey measuring their nutrition knowledge using a food frequency table at several timepoints. Immediate intervention participants will take the survey 3 times (baseline, after class 4, after class 5). Wait list control participants will take the survey 5 times (baseline, at 1 month after baseline wait list, immediately before class #1, after class #4, after class #5)
Evaluate diabetes nutrition education program impact on self efficacy for healthful eating
Participants will take a self-reported survey measuring their self efficacy for healthy eating using a food frequency table at several timepoints. Immediate intervention participants will take the survey 3 times (baseline, after class 4, after class 5). Wait list control participants will take the survey 5 times (baseline, at 1 month after baseline wait list, immediately before class #1, after class #4, after class #5)

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
January 6, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04254653
Brief Title
Diabetes Nutrition Education for American Indian and Alaska Native Communities
Official Title
Test of a Culturally Tailored Diabetes Nutrition Education Program for Tribal and Urban American Indian and Alaska Native (AIAN) Communities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

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
This study involves pilot testing a newly developed diabetes nutrition education program for American Indian and Alaska Native adults with T2D. The first phase of this study (COMIRB Protocol 18-006) included a qualitative needs assessment to inform the development of this program. The Study Aims include: piloting the newly adapted program at 6 AI/AN collaborating sites to gain feedback on satisfaction, likability, usability and clinical outcomes such as HgA1C (measure of blood sugar control), blood pressure, and body mass index (BMI).
Detailed Description
This study involves pilot testing a newly developed diabetes nutrition education program for American Indian and Alaska Native adults with T2D. The first phase of this study (COMIRB Protocol 18-006) included a qualitative needs assessment to inform the development of this program. The second phase involves pilot testing the study at 6 collaborating AI/AN sites across the US. The Study Aims include: piloting the newly adapted program at 6 AI/AN collaborating sites to gain feedback on satisfaction, likability, usability and clinical outcomes such as HgA1C (measure of blood sugar control), blood pressure, and body mass index (BMI).

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
Participants receive diabetes nutrition education classes immediately.
Arm Title
Wait list intervention
Arm Type
Experimental
Arm Description
Participants wait listed (control) for 3 months and then receive the diabetes nutrition education classes.
Intervention Type
Behavioral
Intervention Name(s)
American Indian and Alaska Native What Can I Eat?
Intervention Description
Participants will engage in 5 ~90 minute diabetes nutrition education classes. They will learn about healthy eating for type 2 diabetes management. Classes include didactic lesson, hands on learning activity, sharing session, mindful nutrition practice, and physical activity
Primary Outcome Measure Information:
Title
Evaluate diabetes nutrition education program impact on HgA1C
Description
Participants will have 2 A1C checks for Immediate intervention and 3 for wait list control. Immediate will have A1C tested at baseline and after the 5th class (at 3 months from baseline). Wait list will have A1C checked baseline, immediately before class #1 (3 months after baseline) and after class #5 (6 months after baseline). A1C will be checked per standard of care at the clinical site
Time Frame
3 months for immediate intervention group 6 months for wait list control group
Title
Evaluate diabetes nutrition education program impact on blood pressure
Description
Participants will have 3 BP checks for Immediate intervention and 5 for wait list control. Immediate will have BP tested at baseline, after the 4th class, and after the 5th class (at 3 months from baseline). Wait list will have BP checked baseline, immediately before class #1 (3 months after baseline), 1 month after baseline, after class #4, and after class #5 (6 months after baseline). Blood pressure will be checked per standard of care at the clinical site.
Time Frame
3 months for immediate intervention group 6 months for wait list control group
Title
Evaluate diabetes nutrition education program impact on weight
Description
Participants will have 3 weight checks for Immediate intervention and 5 for wait list control. Immediate will have weight tested at baseline, after the 4th class, and after the 5th class (at 3 months from baseline). Wait list will have weight checked baseline, at one month of wait list, immediately before class #1 (3 months after baseline), after class #4, and after class #5 (6 months after baseline). Weight will be checked per standard of care at the clinical site.
Time Frame
3 months for immediate intervention group 6 months for wait list control group
Title
Evaluate diabetes nutrition education program impact on eating behavior
Description
Participants will take a self-reported survey measuring their dietary habits using a food frequency table at several timepoints. Immediate intervention participants will take the survey 3 times (baseline, after class 4, after class 5). Wait list control participants will take the survey 5 times (baseline, at 1 month after baseline wait list, immediately before class #1, after class #4, after class #5)
Time Frame
3 months for immediate intervention group 6 months for wait list control group
Title
Evaluate diabetes nutrition education program impact on nutrition knowledge
Description
Participants will take a self-reported survey measuring their nutrition knowledge using a food frequency table at several timepoints. Immediate intervention participants will take the survey 3 times (baseline, after class 4, after class 5). Wait list control participants will take the survey 5 times (baseline, at 1 month after baseline wait list, immediately before class #1, after class #4, after class #5)
Time Frame
3 months for immediate intervention group 6 months for wait list control group
Title
Evaluate diabetes nutrition education program impact on self efficacy for healthful eating
Description
Participants will take a self-reported survey measuring their self efficacy for healthy eating using a food frequency table at several timepoints. Immediate intervention participants will take the survey 3 times (baseline, after class 4, after class 5). Wait list control participants will take the survey 5 times (baseline, at 1 month after baseline wait list, immediately before class #1, after class #4, after class #5)
Time Frame
3 months for immediate intervention group 6 months for wait list control group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: AI/AN status (self-reported) age > 18 years fluent in English a current diagnosis of T2DM. Exclusion Criteria: a major medical issue that may interfere with participation (e.g., prior cardio- or cerebrovascular disease including a recent myocardial infarction or major stroke; cancer not in remission; dialysis; active alcohol and/or substance abuse.) a planned move from the area within the 3 to 6 month data collection time period that would not allow completion of all the study visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly R Moore, MD
Organizational Affiliation
University of Colorado Anschutz Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lakeport Tribal Health Consortium
City
Lakeport
State/Province
California
ZIP/Postal Code
95453
Country
United States
Facility Name
Cherokee Indian Hospital
City
Cherokee
State/Province
North Carolina
ZIP/Postal Code
28719
Country
United States
Facility Name
Indian Health Care Resource Center of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74120
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Diabetes Nutrition Education for American Indian and Alaska Native Communities

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