The Men Are Now United Program

Type2 Diabetes Clinical Trial

— MANUP  

Official title:

Self-Management of Diabetes in Black Men

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03208686
• Other study ID #: CGA#149084
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan State University	Flint	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Michigan State University	Claremont Graduate University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose levels	A1c	4 Months