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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Diabetes Prevention Program

• Registration Number: NCT02952352
• Lead Sponsor: Washington State University

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.

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-02
• Study Start: 2017-03-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-03-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Intervention	Diabetes Prevention Program	Diabetes Prevention Program
Delayed Intervention	Diabetes Prevention Program	Diabetes Prevention Program

Primary Outcome Measures

Name	Time	Method
Weight	12 Weeks	Percent weight loss

Secondary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure	12 weeks	blood pressure monitor
Stages of Change for weight loss	12 weeks	Transtheoretical model of stages of change questionnaire

Trial Locations

Locations (2)

Confederated Tribes of the Colville Reservation; 🇺🇸 Nespelem, Washington, United States

IREACH; 🇺🇸 Seattle, Washington, United States