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Completed

NCT Number: NCT03208686

The Men Are Now United Program

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

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.

Primary outcomes

  1. Blood glucose levels

    Time frame: 4 Months

    A1c

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Claremont Graduate University
  • University of Michigan

Registry information

Official study title

Self-Management of Diabetes in Black Men

Acronym: MANUP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2017
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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