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Completed

NCT Number: NCT05038176

Improving the Diabetic Health of Black Men: MANUP 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Coping Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Masculinity Metabolic Diseases Nutritional and Metabolic Diseases Self Efficacy Social Behavior

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

North Carolina Central University

Durham, North Carolina, 27703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

MANUP

Behavioral

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.

Primary outcomes

  1. A1c

    Time frame: 6 months

    Hemoglobin A1c (determine diabetes status over previous 2 months)

Sponsors and collaborators

Lead sponsor

North Carolina Central University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: MANUP-NC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2021
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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