NCT03208686

The Men Are Now United Program

Self-Management of Diabetes in Black Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Michigan State University · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Intervention Group	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.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-12-19
• Completion: 2019-12-19
• First posted: 2017-07-05
• Last updated: 2025-03-06

Locations

1 site across 1 country: United States