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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Coping Behavior; Self Efficacy; Masculinity
• Intervention / Treatment: Behavioral: MANUP

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 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • North Carolina Central University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active intervention group (AI); The active intervention group (AI) receiving the active treatment (MANUP intervention) which include diabetes education, diabetes support with a focus on coping techniques (based on John Henryism concepts), physical activity engagement and motivational text messages.	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.
Active Comparator: Delayed intervention group (DI); DI participants will only receive motivational text-messages. They will then "flip" and receive full intervention after the AI group has completed the program.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1c	Hemoglobin A1c (determine diabetes status over previous 2 months)	6 months

Collaborators and Investigators

• Sponsor: North Carolina Central University
• Collaborators: University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NCCU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No