Clinical trial NCT04254653: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Evaluate diabetes nutrition education program impact on HgA1C
timeFrame: 3 months for immediate intervention group 6 months for wait list control group
measure: Evaluate diabetes nutrition education program impact on blood pressure
timeFrame: 3 months for immediate intervention group 6 months for wait list control group
measure: Evaluate diabetes nutrition education program impact on weight
timeFrame: 3 months for immediate intervention group 6 months for wait list control group
measure: Evaluate diabetes nutrition education program impact on eating behavior
timeFrame: 3 months for immediate intervention group 6 months for wait list control group
measure: Evaluate diabetes nutrition education program impact on nutrition knowledge
timeFrame: 3 months for immediate intervention group 6 months for wait list control group
measure: Evaluate diabetes nutrition education program impact on self efficacy for healthful eating
timeFrame: 3 months for immediate intervention group 6 months for wait list control group
Secondary outcomes:
Other outcomes:
Locations:
city: Lakeport
country: United States
facility: Lakeport Tribal Health Consortium
state: California
city: Cherokee
country: United States
facility: Cherokee Indian Hospital
state: North Carolina
city: Tulsa
country: United States
facility: Indian Health Care Resource Center of Tulsa
state: Oklahoma
Study officials:
affiliation: University of Colorado, Denver
name: Kelly R Moore, MD
role: PRINCIPAL_INVESTIGATOR
References: