Nxstan: A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men
NARCH
A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men
1 other identifier
interventional
100
1 country
2
Brief Summary
To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the Colville reservation through a community-based, culturally informed intervention, the study specifically aims to: 1. conduct focus groups and interviews with adult members of Colville tribe to inform the adaptation, manualization and implementation of a culturally informed diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness of a community-based, culturally informed diabetes prevention intervention by assessing between group changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Mar 2017
Typical duration for not_applicable diabetes
2 active sites
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
October 31, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedFebruary 16, 2023
February 1, 2023
1.9 years
October 31, 2016
February 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Weight
Percent weight loss
12 Weeks
Secondary Outcomes (2)
Systolic and diastolic blood pressure
12 weeks
Stages of Change for weight loss
12 weeks
Study Arms (2)
Diabetes Intervention
EXPERIMENTALDiabetes Prevention Program
Delayed Intervention
OTHERDiabetes Prevention Program
Interventions
Culturally adapted diabetes prevention program
Eligibility Criteria
You may qualify if:
- Must be male and self-reported American Indian; Reside in or near Colville tribe; ages 21-65, A BMI ≥25 kg/m2 and/or a waist circumference \>90 cm for men; no prior diabetes diagnosis; No history of heart disease, serious illness, cancer diagnosis in the last five years, or other conditions that may impede or prohibit participation; and, willingness to consent to randomization
You may not qualify if:
- Females, under 18 years old or older than 65 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Confederated Tribes of the Colville Reservation
Nespelem, Washington, 99155, United States
IREACH
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Odile A Madesclaire
Washington State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Program and Operations Manager
Study Record Dates
First Submitted
October 31, 2016
First Posted
November 2, 2016
Study Start
March 1, 2017
Primary Completion
January 30, 2019
Study Completion
March 30, 2019
Last Updated
February 16, 2023
Record last verified: 2023-02