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Clinical Trials/NCT03208686
NCT03208686
Completed
Not Applicable

Self-Management of Diabetes in Black Men

Michigan State University1 site in 1 country41 target enrollmentApril 1, 2019
ConditionsType2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type2 Diabetes
Sponsor
Michigan State University
Enrollment
41
Locations
1
Primary Endpoint
Blood glucose levels
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
December 19, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Black/African American
  • 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

Outcomes

Primary Outcomes

Blood glucose levels

Time Frame: 4 Months

A1c

Study Sites (1)

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