Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05038176
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2021-08-31
Brief Title:
Improving the Diabetic Health of Black Men MANUP Feasibility Trial
Sponsor:
North Carolina Central University
Organization:
North Carolina Central University
Study Overview
Official Title:
Improving the Diabetic Health of Black Men MANUP-NC MANUP-NC Feasibility Trial
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANUP-NC
Brief Summary:
Many Black Americans continue to be suffer from diabetes especially Black men Although previous diabetes efforts have reduced overall disease burden they have failed to eliminate racial and geographic disparities The story of John Henry the steel-drivin man represents strength and self-determination among Black Men But often these traits lead men to manup about their health and prevents them from taking care of their diabetes This study examines how we can assist Black men in improving their diabetes Based on the traits of John Henry we will conduct a culturally-tailored study to 1 determine if our education program including coping strategies and motivation text messages lowers A1c and 2 how program operates in a rural setting while learning how we can best improve it for a larger study We hope to have the information to conduct a larger study with Black men in rural areas to improve their diabetes outcomes
Detailed Description:
As the United States 7th leading cause of death improving diabetic outcomes is a public health priority Black American men disproportionately suffer from diabetes more than White counterparts John Henryism endorses traditional masculine norms for Black Men such as self-determination and strength as assets However these norms can also act as barriers to diabetes self-management as they restrict access to support from family and friends at a time when it is most needed
The purpose of this application is to pilot a targeted culturally-tailored diabetes self-management intervention for 50 rural Black men to improve diabetes-related outcomes Aim 1 Implement a 6-month diabetes self-management intervention grounded in John Henryism with two arms consisting of the active intervention group and a delayed intervention group to test the interventions effect on the primary outcome of A1c change Aim 2 Determine the feasibility of conducting a 6-month culturally-tailored diabetes self-management intervention for Black men in a rural NC community
The intervention includes a 10-week education program focusing on self-management social support and coping strategies and daily motivational text messages Aim 1 analysis includes repeated measures t-test or the non-parametric equivalent Wilcoxon Matched Pairs test to compare the mean scores of the both groups pre and post intervention Aim 2 analysis focuses on key parameters required for conducting a future trial This innovative study leverages the self-reliance and active coping mechanisms of John Henryism by fostering self-determination to properly self-manage diabetes while providing stress management and coping skills to buffer John Henryisms adverse effects
The purpose of this application is to pilot a targeted culturally-tailored diabetes self-management intervention for 50 rural Black men to improve diabetes-related outcomes Aim 1 Implement a 6-month diabetes self-management intervention grounded in John Henryism with two arms consisting of the active intervention group and a delayed intervention group to test the interventions effect on the primary outcome of A1c change Aim 2 Determine the feasibility of conducting a 6-month culturally-tailored diabetes self-management intervention for Black men in a rural NC community
The intervention includes a 10-week education program focusing on self-management social support and coping strategies and daily motivational text messages Aim 1 analysis includes repeated measures t-test or the non-parametric equivalent Wilcoxon Matched Pairs test to compare the mean scores of the both groups pre and post intervention Aim 2 analysis focuses on key parameters required for conducting a future trial This innovative study leverages the self-reliance and active coping mechanisms of John Henryism by fostering self-determination to properly self-manage diabetes while providing stress management and coping skills to buffer John Henryisms adverse effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None