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

Washington State University logo

Washington State University

Status

Completed

Conditions

Diabetes

Treatments

Behavioral: Diabetes Prevention Program

Study type

Interventional

Funder types

Other

Identifiers

NCT02952352
U261IHS0086-01-00

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Male

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Diabetes Intervention
Experimental group
Description:
Diabetes Prevention Program
Treatment:
Behavioral: Diabetes Prevention Program
Delayed Intervention
Other group
Description:
Diabetes Prevention Program
Treatment:
Behavioral: Diabetes Prevention Program

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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