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Diabetes Nutrition Education for American Indian and Alaska Native Communities

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Unknown

Conditions

Type 2 Diabetes

Treatments

Behavioral: American Indian and Alaska Native What Can I Eat?

Study type

Interventional

Funder types

Other

Identifiers

NCT04254653
19-2269

Details and patient eligibility

About

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).

Full 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).

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

150 participants in 2 patient groups

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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