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

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ClinicalTrials.gov Identifier: NCT02952352
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ka'imi Sinclair, Washington State University

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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Diabetes Prevention Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : March 30, 2019

Arm Intervention/treatment
Experimental: Diabetes Intervention
Diabetes Prevention Program
Behavioral: Diabetes Prevention Program
Culturally adapted diabetes prevention program

Delayed Intervention
Diabetes Prevention Program
Behavioral: Diabetes Prevention Program
Culturally adapted diabetes prevention program




Primary Outcome Measures :
  1. Weight [ Time Frame: 12 Weeks ]
    Percent weight loss


Secondary Outcome Measures :
  1. Systolic and diastolic blood pressure [ Time Frame: 12 weeks ]
    blood pressure monitor

  2. Stages of Change for weight loss [ Time Frame: 12 weeks ]
    Transtheoretical model of stages of change questionnaire



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952352


Locations
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United States, Washington
Confederated Tribes of the Colville Reservation
Nespelem, Washington, United States, 99155
IREACH
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Washington State University
Investigators
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Principal Investigator: Kaimi A Sinclair, PhD, MPH Washington State University

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Responsible Party: Ka'imi Sinclair, Assistant Professor, Washington State University
ClinicalTrials.gov Identifier: NCT02952352     History of Changes
Other Study ID Numbers: U261IHS0086-01-00
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases