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Completed

NCT Number: NCT02952352

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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Confederated Tribes of the Colville Reservation, Nespelem, Washington, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes Prevention Program

Behavioral

Culturally adapted diabetes prevention program

Primary outcomes

  1. Weight

    Time frame: 12 Weeks

    Percent weight loss

Secondary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: 12 weeks

    blood pressure monitor

  2. Stages of Change for weight loss

    Time frame: 12 weeks

    Transtheoretical model of stages of change questionnaire

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Official study title

A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men

Acronym: NARCH

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2016
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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