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Strong Men, Strong Communities Diabetes Risk Reduction in American Indian Men (SMSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02953977
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : June 17, 2019
Information provided by (Responsible Party):
Ka'imi Sinclair, Washington State University

Brief Summary:
SMSC will inform the design and implementation of culturally informed, community-based lifestyle interventions for diabetes prevention in AI men in our partner communities and elsewhere, as well as in men of other minority groups who experience a heavy burden of diabetes.

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

Detailed Description:

American Indian (AI) males experience profound health disparities compared to their counterparts in all other U.S. racial and ethnic groups. AI men have the highest age-adjusted prevalence of type 2 diabetes (~18%) among U.S. men, while non-Hispanic White men have the lowest (~7%). In recent decades, AIs have seen a disproportionate increase in diabetes-related complications and mortality compared to all other groups, such that age-adjusted diabetes death rates in AI men are now almost twice those in White men.

Several large randomized, con trolled trials in non-AIs confirm that type 2 diabetes can be prevented or delayed by interventions that promote healthy lifestyles, but little empirical data exist on interventions to prevent diabetes in AI men. In the clinic-based U.S. Diabetes Prevention Program (DPP), only 55 out of 3,234 participants were AI men. Similarly, in the diabetes prevention programs in Native communities, participation by AI males is low, ranging from 33% to 74%. Many explanations have been posited for the low participation rates among men of all races in lifestyle interventions. Recruiting AI men in clinic-based programs is difficult because they tend to seek clinical care less often than women. AI men's perceptions of normative health behaviors and gender roles may also discourage participation, particularly in mixed-gender groups. Therefore, an urgent need exists for diabetes risk reduction programs tailored to the unique values and habits of AI men, with a particular focus on recruitment and retention

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Strong Men, Strong Communities: Cultural Tradition to Improve Native Men's Health
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
Experimental: Diabetes Intervention
Diabetes Prevention Program
Behavioral: Diabetes Prevention Program
An adapted version of the Diabetes Prevention Program will be delivered to intervention participants.

Delayed Intervention
Diabetes Prevention Program
Behavioral: Diabetes Prevention Program
An adapted version of the Diabetes Prevention Program will be delivered to intervention participants.

Primary Outcome Measures :
  1. Change in diabetes risk score [ Time Frame: 12 months ]
    Strong Heart Study Diabetes Risk Score calculator

Secondary Outcome Measures :
  1. Change in Body Mass Index [ Time Frame: 12 months ]
    weight (kg) / [height (m)]2

  2. Change in Stages of Change [ Time Frame: 12 months ]
    Transtheoretical model of stage of change for weight loss

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Must be male and self-reported American Indian; ages 18-75, 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 identifier (NCT number): NCT02953977

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Contact: Kaimi A Sinclair, PhD, MPH 206-708-8633

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United States, Washington
IREACH Recruiting
Seattle, Washington, United States, 98101
Contact: Kaimi Sinclair, PhD, MPH   
Contact: Amber Fyfe-Johnson, ND, PhD   
Sponsors and Collaborators
Washington State University
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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 Identifier: NCT02953977     History of Changes
Other Study ID Numbers: 1R01DK102728-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No