Clinical Trials Logo

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT05038176
Study type Interventional
Source North Carolina Central University
Contact Dana Carthron, PhD
Phone 9195307222
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 15, 2021
Completion date September 15, 2022

See also
  Status Clinical Trial Phase
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Recruiting NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Recruiting NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Recruiting NCT05026723 - Food as Medicine for HIV and Diabetes N/A
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Not yet recruiting NCT04542148 - Glycemic Control After Antenatal Corticosteroids in Women With Pregestational Diabetes Phase 2
Recruiting NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in Individuals With Recent-onset Type 2 Diabetes and Monogenic Diabetes Phase 2
Completed NCT04183257 - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics Phase 4
Completed NCT02897349 - Linagliptin Add-on to Insulin Background Therapy Phase 3
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting NCT03821961 - 18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery N/A