Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574035
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Michigan Mens Diabetes Project 3 MenD 3 Mind and Motion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Michigan Mens Diabetes Project 3 MenD 3 Mind and Motion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MenDIII
Brief Summary:
The Michigan Mens 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 and with depression Patient Health Questionnaire - 9 score over 5 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 70 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 tabletphonecomputer 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 hourssessions 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None