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

Diabetes Clinical Trial

— NARCH  

Official title:

A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952352
• Other study ID #: U261IHS0086-01-00
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: February 2023
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Behavioral:
• Diabetes Prevention Program
Culturally adapted diabetes prevention program

Locations

Country	Name	City	State
United States	Confederated Tribes of the Colville Reservation	Nespelem	Washington
United States	IREACH	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Percent weight loss	12 Weeks
Secondary	Systolic and diastolic blood pressure	blood pressure monitor	12 weeks
Secondary	Stages of Change for weight loss	Transtheoretical model of stages of change questionnaire	12 weeks