DiabetesSMSCNCT02953977
Strong Men, Strong Communities Diabetes Risk Reduction in American Indian Men
A study testing Diabetes Prevention Program in people with Diabetes, run by Washington State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Diabetes Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Females, under 18 years old or older than 75 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Diabetes
- Being tested
- Diabetes Prevention Program
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention ProgramBehavioural
An adapted version of the Diabetes Prevention Program will be delivered to intervention participants.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Intervention | Experimental | Diabetes Prevention Program Receives: Behavioral: Diabetes Prevention Program |
| Delayed Intervention | Other | Diabetes Prevention Program Receives: Behavioral: Diabetes Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline weight
7.5% weight loss from baseline weight
Measured: 6 months
Secondary outcomes (2)
Change in dietary habits and consumption and frequency of physical activity
Dietary change using the NCI Fat \& Veg Screener and Fruit Screener
Measured: 6 months
Changes in Stages of Change for healthy eating and physical activity
Transtheoretical model of stage of change for weight loss
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start15 Jun 2018
- Primary completion30 Oct 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Dillard, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953977
- Sponsor's protocol ID
- 1R01DK102728-01A1
- Acronym
- SMSC
- Status last verified
- Aug 2023
- First submitted
- 1 Nov 2016
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34485829Sinclair 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.
PubMed 32757825
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong Men, Strong Communities: Cultural Tradition to Improve Native Men's Health
- ClinicalTrials.gov ID
- NCT02953977
- Acronym / sponsor ID
- SMSC / 1R01DK102728-01A1
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Block randomized
| Arm | Type | Receives |
|---|---|---|
| Diabetes Intervention | Experimental | Behavioral: Diabetes Prevention ProgramDiabetes Prevention Program |
| Delayed Intervention | Other | Behavioral: Diabetes Prevention ProgramDiabetes Prevention Program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Females, under 18 years old or older than 75 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Prevention ProgramAn adapted version of the Diabetes Prevention Program will be delivered to intervention participants. | Behavioural | Delayed Intervention, Diabetes Intervention |
Primary outcome
Change from baseline weight
Time frame: 6 months
7.5% weight loss from baseline weight
2 secondary outcomes
Change in dietary habits and consumption and frequency of physical activity
Time frame: 6 months
Changes in Stages of Change for healthy eating and physical activity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Results publication: PubMed 34485829Sinclair 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.
- Results publication: PubMed 32757825Sinclair 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Program in people with Diabetes, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953977, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.