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The Men Are Now United Program (MANUP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208686
Recruitment Status : Active, not recruiting
First Posted : July 5, 2017
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
University of Michigan
Claremont Graduate University
Information provided by (Responsible Party):
Harold Woody Neighbors, 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: Intervention Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-Management of Diabetes in Black Men
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Blood glucose levels [ Time Frame: 4 Months ]
    A1c



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identification
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208686


Locations
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United States, Michigan
Michigan State University
Flint, Michigan, United States, 48502
Sponsors and Collaborators
Michigan State University
University of Michigan
Claremont Graduate University
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Responsible Party: Harold Woody Neighbors, Professor of Public Health & Family Medicine, Michigan State University
ClinicalTrials.gov Identifier: NCT03208686    
Other Study ID Numbers: CGA#149084
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Harold Woody Neighbors, Michigan State University:
Gender
Men
Black/African American
Self-management