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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Diabetes Prevention Program

• Registration Number: NCT02953977
• Lead Sponsor: 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.

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

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Study Start: 2018-06-15
• Primary Completion: 2021-10-30
• Study Completion: 2023-06-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 257

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Intervention	Diabetes Prevention Program	Diabetes Prevention Program
Delayed Intervention	Diabetes Prevention Program	Diabetes Prevention Program

Primary Outcome Measures

Name	Time	Method
Change from baseline weight	6 months	7.5% weight loss from baseline weight

Secondary Outcome Measures

Name	Time	Method
Changes in Stages of Change for healthy eating and physical activity	12 months	Transtheoretical model of stage of change for weight loss
Change in dietary habits and consumption and frequency of physical activity	6 months	Dietary change using the NCI Fat \& Veg Screener and Fruit Screener

Trial Locations

Locations (1)

IREACH; 🇺🇸 Seattle, Washington, United States