NCT04254653

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

January 28, 2020

Last Update Submit

January 6, 2022

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (6)

  • 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

    3 months for immediate intervention group 6 months for wait list control group

  • 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.

    3 months for immediate intervention group 6 months for wait list control group

  • 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.

    3 months for immediate intervention group 6 months for wait list control group

  • 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)

    3 months for immediate intervention group 6 months for wait list control group

  • 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)

    3 months for immediate intervention group 6 months for wait list control group

  • 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)

    3 months for immediate intervention group 6 months for wait list control group

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Participants receive diabetes nutrition education classes immediately.

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

Wait list intervention

EXPERIMENTAL

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

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

Interventions

American Indian and Alaska Native What Can I Eat?BEHAVIORAL

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

Immediate InterventionWait list intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Lakeport Tribal Health Consortium

Lakeport, California, 95453, United States

Location

Cherokee Indian Hospital

Cherokee, North Carolina, 28719, United States

Location

Indian Health Care Resource Center of Tulsa

Tulsa, Oklahoma, 74120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kelly R Moore, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

February 5, 2020

Study Start

February 20, 2020

Primary Completion

December 30, 2021

Study Completion

May 31, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)