Improving the Diabetic Health of Black Men: MANUP Feasibility Trial

Diabetes Mellitus, Type 2 Clinical Trial

— MANUP-NC  

Official title:

Improving the Diabetic Health of Black Men (MANUP-NC): MANUP-NC Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038176
• Other study ID #: NCCU
• Status: Completed
• Phase: N/A
• Start date: February 12, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2023
• Source: North Carolina Central University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 intervention's 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 Henryism's adverse effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1) reside in Halifax, County or Alamance County NC; 2) age 21 or older; (3) English language proficient; 4) able to walk unaided; 4) self-reported type 2 diabetes diagnosis.

Exclusion Criteria:

• Exclusion criteria includes being non-ambulatory or having a diagnosis that would preclude them from participating in an exercise program.

Related Conditions & MeSH terms

• Coping Behavior
• Diabetes Mellitus, Type 2
• Masculinity
• Self Efficacy

Intervention

Behavioral:
• MANUP
Intervention will include diabetes education, diabetes support with a focus on coping techniques (based on John Henryism concepts), physical activity engagement and motivational text messages.

Locations

Country	Name	City	State
United States	North Carolina Central University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
North Carolina Central University	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c	Hemoglobin A1c (determine diabetes status over previous 2 months)	6 months