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

NCT ID: NCT02952352

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-03-30

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Diabetes Intervention

Diabetes Prevention Program

Group Type: EXPERIMENTAL

Diabetes Prevention Program

Intervention Type: BEHAVIORAL

Culturally adapted diabetes prevention program

Delayed Intervention

Diabetes Prevention Program

Group Type: OTHER

Diabetes Prevention Program

Intervention Type: BEHAVIORAL

Culturally adapted diabetes prevention program

Interventions

Diabetes Prevention Program

Culturally adapted diabetes prevention program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Washington State University

OTHER

Sponsor Role: lead

Responsible Party

Odile Madesclaire

Senior Research Program and Operations Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Odile A Madesclaire

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

Confederated Tribes of the Colville Reservation

Nespelem, Washington, United States

IREACH

Seattle, Washington, United States

Countries

United States

Other Identifiers

U261IHS0086-01-00

Identifier Type: -

Identifier Source: org_study_id