Diabetes Nutrition Education for American Indian and Alaska Native Communities

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: American Indian and Alaska Native What Can I Eat?

• Registration Number: NCT04254653
• Lead Sponsor: University of Colorado, Denver

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).

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Study Start: 2020-02-20
• Primary Completion: 2021-12-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Immediate Intervention	American Indian and Alaska Native What Can I Eat?	Participants receive diabetes nutrition education classes immediately.
Wait list intervention	American Indian and Alaska Native What Can I Eat?	Participants wait listed (control) for 3 months and then receive the diabetes nutrition education classes.

Primary Outcome Measures

Name	Time	Method
Evaluate diabetes nutrition education program impact on nutrition knowledge	3 months for immediate intervention group 6 months for wait list control group	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 HgA1C	3 months for immediate intervention group 6 months for wait list control group	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 eating behavior	3 months for immediate intervention group 6 months for wait list control group	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 blood pressure	3 months for immediate intervention group 6 months for wait list control group	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 self efficacy for healthful eating	3 months for immediate intervention group 6 months for wait list control group	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)
Evaluate diabetes nutrition education program impact on weight	3 months for immediate intervention group 6 months for wait list control group	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.

Trial Locations

Locations (3)

Lakeport Tribal Health Consortium; 🇺🇸 Lakeport, California, United States

Cherokee Indian Hospital; 🇺🇸 Cherokee, North Carolina, United States

Indian Health Care Resource Center of Tulsa; 🇺🇸 Tulsa, Oklahoma, United States