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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03208686
Study type Interventional
Source Michigan State University
Contact
Status Active, not recruiting
Phase N/A
Start date April 1, 2019
Completion date December 31, 2019

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