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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Diabetes Prevention Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Intervention<br>Diabetes Prevention Program | Behavioral: Diabetes Prevention Program<br>* Culturally adapted diabetes prevention program<br>|
| Other: Delayed Intervention<br>Diabetes Prevention Program | Behavioral: Diabetes Prevention Program<br>* Culturally adapted diabetes prevention program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Percent weight loss | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressure | blood pressure monitor | 12 weeks | 
| Stages of Change for weight loss | Transtheoretical model of stages of change questionnaire | 12 weeks |