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Nxstan: A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men

A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02952352
Acronym
NARCH
Enrollment
113
Registered
2016-11-02
Start date
2017-03-01
Completion date
2019-03-30
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Detailed description

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 in: Primary Outcomes: weight, dietary fat and caloric intake, vegetable consumption, and physical activity; Secondary Outcomes: physical fitness, blood pressure, lipids, self-reported quality of life; and, 3. evaluate the sustainability of the diabetes prevention intervention by assessing participant perceptions of program component fit through focus group discussions with participants in the intervention and telephone interviews with those who left the program.

Interventions

Culturally adapted diabetes prevention program

Sponsors

Washington State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Females, under 18 years old or older than 65 years

Design outcomes

Primary

MeasureTime frameDescription
Weight12 WeeksPercent weight loss

Secondary

MeasureTime frameDescription
Systolic and diastolic blood pressure12 weeksblood pressure monitor
Stages of Change for weight loss12 weeksTranstheoretical model of stages of change questionnaire

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOROdile A Madesclaire

Washington State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026