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Completed

NCT Number: NCT02953977

Strong Men, Strong Communities Diabetes Risk Reduction in American Indian Men

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

IREACH

Seattle, Washington, 98101, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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; reliable internet access; access to a computer, tablet, or smartphone; have an active email address; and, willingness to consent to randomization

Exclusion criteria

  • Females, under 18 years old or older than 75 years

Treatment and study plan

Diabetes Prevention Program

Behavioral

An adapted version of the Diabetes Prevention Program will be delivered to intervention participants.

Primary outcomes

  1. Change from baseline weight

    Time frame: 6 months

    7.5% weight loss from baseline weight

Secondary outcomes

  1. Change in dietary habits and consumption and frequency of physical activity

    Time frame: 6 months

    Dietary change using the NCI Fat & Veg Screener and Fruit Screener

  2. Changes in Stages of Change for healthy eating and physical activity

    Time frame: 12 months

    Transtheoretical model of stage of change for weight loss

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Official study title

Strong Men, Strong Communities: Cultural Tradition to Improve Native Men's Health

Acronym: SMSC

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Nov 3, 2016
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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