The Men Are Now United Program

Study Overview
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Brief Summary
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The purpose of this application is to create and implement a targeted, culturally grounded, diabetes self-management intervention for Black men that uses social support, mobile health, and remote sensing technology to improve diabetes-related outcomes.

Detailed Description
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The investigators propose a single-subject, repeated measures intervention where each participant will serve their own control. Participants will serve as their own controls for a period of three months prior to the start of the four-month intervention. The study will conclude with an assessment 7-months from baseline. Single-subject designs are most often used in applied research. The design allows the participant to serve as the control, rather than using another individual/group. The design is sensitive to individual differences whereas group designs are sensitive to averages of groups. Year 1 is dedicated to the development of the text messages and the content for the 10 group meeting sessions. Year 2 focuses on the Time-1 control period assessment (pre-baseline at 3 months before the intervention), the Time-2 assessment (baseline), implementation of the 10-week intervention, a post-intervention assessment (Time-3), and 3-month follow up at Time-4, and analysis. Specifically, in Year 2, the primary outcome of A1c will be assessed at Time-1, 3 months later at the start of the intervention, at the end of the intervention, and at 7-months. The investigators will also include secondary assessments of glucose readings, waist circumference, and blood pressure.

Official Title
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Self-Management of Diabetes in Black Men

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Behavioral: Intervention Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Black/African American Male Tyep 2 Diabetes 21 years old or older Owns cell or smart (mobile) phone or willing to use one if provided Exclusion Criteria: Non-ambulatory Serious physical illness Psychiatric diagnosis of serious mental illness Serious diabetes complications impeding meaningful participation

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Group<br>A single-arm intervention comprised of discussion groups, text messages, and a cloud-based cellular glucometer. | Behavioral: Intervention Group<br>* A single-arm intervention comprised of (a) 10 weekly discussion groups; (b) motivational text messages; (c) a remote sensing persuasive health technology - a cloud-based cellular glucometer connected to a dedicated web site to reduce A1c by 0.5% by improving diabetes self-management behaviors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose levels | A1c | 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gender, Men, Black/African American, Self-management