The Men Are Now United Program (MANUP)

Michigan State University

Status: Completed

Conditions: Type2 Diabetes

Treatments: Behavioral: Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03208686

CGA#149084

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Intervention Group

Other group

Description:

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

Treatment:

Behavioral: Intervention Group