Clinical trial NCT02952352: Nxstan: A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men
Official title: A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight
timeFrame: 12 Weeks
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: 12 weeks
measure: Stages of Change for weight loss
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nespelem
country: United States
facility: Confederated Tribes of the Colville Reservation
state: Washington
city: Seattle
country: United States
facility: IREACH
state: Washington
Study officials:
affiliation: Washington State University
name: Odile A Madesclaire
role: PRINCIPAL_INVESTIGATOR
References: