Advancing DSME/S and COVID-19 Prevention and Protection Through "emPOWERed to Change" Program
NCT04993326 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2023-02-22
Summary
African Americans (AA)/People of Color (POC) are disproportionately impacted by COVID-19 to an extent not observed in other racial/ethnic subgroups. People of color are uniquely affected because keeping diabetes under control - the best defense against COVID-19 - has become more difficult as the pandemic has disrupted medical care, exercise and healthy eating routines which are already well-known challenges for the African American community. Diabetes Self-Management Education and Support (DSMS/S) facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. Now, given the implications of COVID-19 on the AA/POC diabetes community, it is imperative to enhance DSME/S with education about protection and prevention of COVID-19. To begin to solve this problem we will adapt and implement the "emPOWERed to Change" DSME/S program to provide enhanced type 2 diabetes mellitus (T2DM) education with an additional emphasis on COVID-19 protection and prevention. This study will employ Community Based Participatory Research methods and will be conducted virtually in the community setting. The proposed hypothesis, based on the Health Belief Model (HBM) and the Theory of Planned Behavior (TPB), is: African Americans (AA)/People of Color (POC) in Los Angeles County with type 2 diabetes mellitus (T2DM) randomized to participate in the "emPOWERed to Change" program (N=48) are more likely to demonstrate sustained glycemic control, increase in knowledge and skills related behaviors, and risk factors associated with T2DM and SARS-CoV-2 (COVID-19) and increased compliance with prevention, and vaccination as compared to those who are randomized to usual care (N=48) in this 12 week program. We propose a randomized control study design among 96 participants with 48 assigned to an intervention group and 48 assigned to a control group. This study will also explore the experience of the participants' appraisal of knowledge and skills acquisition for DSME/S to maintain T2DM control, reduce complications, and SARS-CoV-2 (COVID-19) prevention and protection. The ultimate goal is to design prospective larger behavioral studies (SuRe first or R21) with a multi-centered intervention with other RTRN institutions to demonstrate the applicability of this approach specifically focusing on the AA/POC community.
Conditions
- Type2 Diabetes
- Covid19
Interventions
- BEHAVIORAL
-
emPOWERed To Change Program
Online Diabetes Self-Management Education and Support along with COVID-19 prevention and protection (vaccination) education and resource information
Sponsors & Collaborators
-
Charles Drew University of Medicine and Science
lead OTHER
Principal Investigators
-
Jay Vadgama, M.D. · Charles Drew University of Medicine and Science
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-10
- Primary Completion
- 2022-09-30
- Completion
- 2023-02-28
More Related Trials
-
Brazilian Diabetes Prevention Program: Pilot Study
NCT05689658 ·Status: COMPLETED ·Phase: NA
-
Program ACTIVE: Phase 2
NCT04369001 ·Status: WITHDRAWN ·Phase: NA
-
Taking Action Together- A Diabetes Prevention Program
NCT01039116 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Prevent in Underserved Populations
NCT02664064 ·Status: COMPLETED ·Phase: NA
-
Diabetes Reversal Online Program and Study (DROP Study)
NCT05572502 ·Status: RECRUITING ·Phase: NA
-
COVID-19 Risk Reduction Among African American Parishioners
NCT04542343 ·Status: COMPLETED ·Phase: NA
-
Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers
NCT03781102 ·Status: TERMINATED ·Phase: NA
-
The Inspiring Action to Prevent Diabetes Intervention
NCT06001801 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community
NCT04571723 ·Status: COMPLETED ·Phase: NA
-
Cholesterol, Hypertension and Glucose Education Study
NCT00815789 ·Status: COMPLETED ·Phase: NA
-
Diabetes Prevention Program
NCT00004992 ·Status: COMPLETED ·Phase: PHASE3
-
Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations
NCT03802825 ·Status: COMPLETED ·Phase: NA
-
Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
NCT03270436 ·Status: COMPLETED ·Phase: NA
-
Reducing Disparities in Diabetes Risk Through Lifestyle Changes in Community Settings
NCT00770926 ·Status: COMPLETED ·Phase: NA
-
REACH Detroit Partnership Family Intervention
NCT00800410 ·Status: COMPLETED ·Phase: PHASE2
-
Diabetes Virtual Trek: Obesity and Diabetes Prevention Through Science Enrichment
NCT00542113 ·Status: COMPLETED ·Phase: NA
-
Soccer-based Adaptation of the Diabetes Prevention Program
NCT03595384 ·Status: COMPLETED ·Phase: NA
-
Project Dulce for Filipino-Americans With Type 2 Diabetes
NCT05378620 ·Status: COMPLETED ·Phase: NA
-
Preventing Diabetes in Latino Families
NCT05228522 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians
NCT01084928 ·Status: COMPLETED ·Phase: NA
-
NUTRITION MATTERS: A Food is Medicine Intervention for African-American Adults With Multiple Chronic Conditions
NCT06933940 ·Status: COMPLETED ·Phase: NA
-
Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes
NCT03096002 ·Status: UNKNOWN
-
The Dietary Guidelines 3 Diet Patterns Study (DG3D): Phase 2
NCT05254496 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Family Diabetes Prevention Program Pilot Study
NCT05358444 ·Status: COMPLETED ·Phase: NA
-
Diabetes Prevention in Prediabetic Patients
NCT01659697 ·Status: UNKNOWN