RECRUITING

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-13
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06574035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * African American/Black males
  2. * age 18 years or older
  3. * ambulatory status
  4. * diagnosis of Type 2 Diabetes (T2D) for one year duration or longer
  5. * be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year
  6. * be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments)
  7. * 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
  8. * live in the Wayne or Washtenaw County\\
  9. * have reliable transportation to in-person events
  1. * stage 2 hypertension as defined by Joint National Committee (JNC) VIII
  2. * recent cardiac events
  3. * recent laser surgery for proliferative retinopathy
  4. * history of stroke
  5. * lower limb amputation
  6. * peripheral neuropathy
  7. * severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)
  8. * class III or IV heart failure
  9. * medical instability.
  10. * ongoing unstable angina
  11. * uncontrolled cardiac arrhythmia with hemodynamic compromise
  12. * active endocarditis
  13. * symptomatic severe aortic stenosis
  14. * acute myocarditis or pericarditis
  15. * acute aortic dissection
  16. * acute pulmonary embolism
  17. * pulmonary infarction
  18. * deep venous thrombosis
  19. * physical disability that precludes safe and adequate testing
  20. * chest discomfort with exertion
  21. * unreasonable breathlessness, or dizziness, fainting, or blackouts.

Contacts and Locations

Study Contact

Jaclynn Hawkins, PhD
CONTACT
(734) 615-2817
jachawk@umich.edu
Hannah Burgess, MPH
CONTACT
(734)-210-1756
hlburges@umich.edu

Principal Investigator

Jaclynn Hawkins, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan, School of Social Work

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Jaclynn Hawkins, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan, School of Social Work

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-13
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-01-13
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2
  • Depressive Symptoms
  • Depression