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

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Washington State University

Status

Completed

Conditions

Diabetes

Treatments

Behavioral: Diabetes Prevention Program

Study type

Interventional

Funder types

Other

Identifiers

NCT02953977
1R01DK102728-01A1

Details and patient eligibility

About

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.

Full 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

Enrollment

257 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

257 participants in 2 patient groups

Diabetes Intervention
Experimental group
Description:
Diabetes Prevention Program
Treatment:
Behavioral: Diabetes Prevention Program
Delayed Intervention
Other group
Description:
Diabetes Prevention Program
Treatment:
Behavioral: Diabetes Prevention Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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