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

Diabetes Clinical Trial

— SMSC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953977
• Other study ID #: 1R01DK102728-01A1
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: June 30, 2023
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	IREACH	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Sinclair K, Carty C, Gonzales K, Nikolaus C, Gillespie L, Buchwald D. Strong Men, Strong Communities: Design of a Randomized Controlled Trial of a Diabetes Prevention Intervention for American Indian and Alaska Native Men. Am J Mens Health. 2020 Jul-Aug;1 — View Citation

Sinclair K, Gonzales K, Woosley C, Cree TR, Garza CM, Buchwald D. An Intersectional Mixed Methods Approach to Understand American Indian Men's Health. Int J Mens Soc Community Health. 2020;3(2):e66-e89. doi: 10.22374/ijmsch.v3i2.35. Epub 2020 Sep 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline weight	7.5% weight loss from baseline weight	6 months
Secondary	Change in dietary habits and consumption and frequency of physical activity	Dietary change using the NCI Fat & Veg Screener and Fruit Screener	6 months
Secondary	Changes in Stages of Change for healthy eating and physical activity	Transtheoretical model of stage of change for weight loss	12 months