Improving the Diabetic Health of Black Men: MANUP Feasibility Trial

NCT05038176 | Completed DMC

• 1 other identifier: NCCU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• A1c

  Hemoglobin A1c (determine diabetes status over previous 2 months)

  6 months

Study Arms (2)

Active intervention group (AI)

EXPERIMENTAL

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

Delayed intervention group (DI)

ACTIVE COMPARATOR

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

Interventions

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.

Active intervention group (AI); Delayed intervention group (DI)

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: 1\) reside in Halifax or Alamance Counties in NC; 2) age 21 or older; (3) English language proficient; 4) able to walk unaided; 4) self-reported type 2 diabetes diagnosis.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

Sponsors & Collaborators

• North Carolina Central University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

North Carolina Central University

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Masculinity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: February 12, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 15, 2024

Record last verified: 2023-03

Locations

US (1)