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

Primary Purpose

Diabetes Mellitus, Type 2, Coping Behavior, Self Efficacy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MANUP
Sponsored by
North Carolina Central University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

1) reside in Halifax, 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.

Sites / Locations

  • North Carolina Central UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active intervention group (AI)

Delayed intervention group (DI)

Arm Description

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.

DI participants will only receive motivational text-messages. They will then "flip" and receive full intervention after the AI group has completed the program.

Outcomes

Primary Outcome Measures

A1c
Hemoglobin A1c (determine diabetes status over previous 2 months)

Secondary Outcome Measures

Full Information

First Posted
August 31, 2021
Last Updated
March 30, 2023
Sponsor
North Carolina Central University
Collaborators
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT05038176
Brief Title
Improving the Diabetic Health of Black Men: MANUP Feasibility Trial
Acronym
MANUP-NC
Official Title
Improving the Diabetic Health of Black Men (MANUP-NC): MANUP-NC Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Carolina Central University
Collaborators
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Coping Behavior, Self Efficacy, Masculinity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active intervention group (AI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed intervention group (DI)
Arm Type
Active Comparator
Arm Description
DI participants will only receive motivational text-messages. They will then "flip" and receive full intervention after the AI group has completed the program.
Intervention Type
Behavioral
Intervention Name(s)
MANUP
Intervention Description
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 Outcome Measure Information:
Title
A1c
Description
Hemoglobin A1c (determine diabetes status over previous 2 months)
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Carthron, PhD
Phone
9195307222
Email
dcarthro@nccu.edu
Facility Information:
Facility Name
North Carolina Central University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Carthron, PhD
Phone
919-530-7222
Email
dcarthro@nccu.edu

12. IPD Sharing Statement

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Improving the Diabetic Health of Black Men: MANUP Feasibility Trial

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