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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2023-06-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Block randomized

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diabetes Intervention

Diabetes Prevention Program

Group Type EXPERIMENTAL

Diabetes Prevention Program

Intervention Type BEHAVIORAL

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

Delayed Intervention

Diabetes Prevention Program

Group Type OTHER

Diabetes Prevention Program

Intervention Type BEHAVIORAL

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

Interventions

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Diabetes Prevention Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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