Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Michigan Men's Diabetes Project III: Mind \& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours/sessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• African American/Black males

• age 18 years or older

• ambulatory status

• diagnosis of Type 2 Diabetes (T2D) for one year duration or longer

• be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year

• be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments)

• have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks

• live in the Wayne or Washtenaw County\

• have reliable transportation to in-person events

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Jaclynn Hawkins, PhD
jachawk@umich.edu
(734) 615-2817
Backup
Hannah Burgess, MPH
hlburges@umich.edu
(734)-210-1756
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2026-06
Participants
Target number of participants: 80
Treatments
Experimental: Intervention Group
Participants randomized to the intervention group will receive 8 one hour virtual sessions of individual cognitive behavioral therapy (CBT) that will take place via U-M Zoom, which is a HIPAA compliant virtual conferencing platform.~Participants in this group will also receive 8 one hour virtual sessions of individual exercise.~Participants in this group will also receive 8 one hour virtual group discussion sessions that will serve as on-going support. This group (4-8 participants) discussion will be facilitated by one CBT Interventionist and one Exercise Interventionist. These sessions will take place following the individual sessions of CBT and Exercise.
Active_comparator: Control Group
Participants randomized to the control group will receive enhanced usual care (EUC). The EUC group will receive 8 sessions of standard Cognitive Behavioral Therapy.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov