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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Diabetes Prevention Program

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 Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • IREACH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetes Intervention; Diabetes Prevention Program	Behavioral: Diabetes Prevention Program; An adapted version of the Diabetes Prevention Program will be delivered to intervention participants.
Other: Delayed Intervention; Diabetes Prevention Program	Behavioral: Diabetes Prevention Program; An adapted version of the Diabetes Prevention Program will be delivered to intervention participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline weight	7.5% weight loss from baseline weight	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Washington State University
• Investigators: Principal Investigator: Kaimi A Sinclair, PhD, MPH, Washington State University

Publications and helpful links

General Publications

• 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.
• 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;14(4):1557988320945457. doi: 10.1177/1557988320945457.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimated): November 3, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1R01DK102728-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No