Strong Men, Strong Communities Diabetes Risk Reduction in American Indian Men
SMSC
1 other identifier
interventional
257
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jun 2018
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedStudy Start
First participant enrolled
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedAugust 14, 2023
August 1, 2023
3.4 years
November 1, 2016
August 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline weight
7.5% weight loss from baseline weight
6 months
Secondary Outcomes (2)
Change in dietary habits and consumption and frequency of physical activity
6 months
Changes in Stages of Change for healthy eating and physical activity
12 months
Study Arms (2)
Diabetes Intervention
EXPERIMENTALDiabetes Prevention Program
Delayed Intervention
OTHERDiabetes Prevention Program
Interventions
An adapted version of the Diabetes Prevention Program will be delivered to intervention participants.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Females, under 18 years old or older than 75 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IREACH
Seattle, Washington, 98101, United States
Related Publications (2)
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.
PMID: 34485829RESULTSinclair 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.
PMID: 32757825RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 1, 2016
First Posted
November 3, 2016
Study Start
June 15, 2018
Primary Completion
October 30, 2021
Study Completion
June 30, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08