The Men Are Now United Program

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Behavioral: Intervention Group

• Registration Number: NCT03208686
• Lead Sponsor: Michigan State University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Study Start: 2019-04-01
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Intervention Group	A single-arm intervention comprised of discussion groups, text messages, and a cloud-based cellular glucometer.

Primary Outcome Measures

Name	Time	Method
Blood glucose levels	4 Months	A1c

Trial Locations

Locations (1)

Michigan State University; 🇺🇸 Flint, Michigan, United States