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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04161846
Other study ID # 1106606-8
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2019
Est. completion date April 25, 2021

Study information

Verified date June 2021
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Standard, effective, and scalable training models are needed to help equip community health workers in their community-based diabetes prevention awareness efforts. This study will tailor/adapt, implement, and evaluate an innovative internet-based virtual world model to remotely deliver a diabetes prevention awareness training program to community health workers.


Description:

Standard, effective, and scalable training models are needed to help equip community health workers in their community-based diabetes prevention awareness efforts. This study will tailor/adapt, implement, and evaluate an innovative internet-based virtual world model to remotely deliver a diabetes prevention awareness training program to community health workers. A sequential mixed-methods design is used to address these specific aims: 1. Use community-based participatory research methods to guide the overall study and inform tailoring and adaptation of our virtual world model to deliver the CHW training program; 2. Conduct a randomized pilot study to compare change in primary outcomes (0, 12 weeks) after the in-person versus virtual world delivery of the program; and 3. Conduct summative focus groups to gather information to refine the program and study methodology.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date April 25, 2021
Est. primary completion date April 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - community health worker - 18-65 years old - Female - Of African American/Black/African ancestry - not getting 150 minutes of physical activity weekly and/or overweight - residing in Chicago/driving distance to Chicago study site - regular access to internet and computer Exclusion Criteria: • does not meet inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Training
The intervention involves a CHW training focused on raising awareness of diabetes prevention in the community. It is delivered remotely over 10 weeks using an internet based approach.
In Person Training
The intervention involves a CHW training focused on raising awareness of diabetes prevention in the community. It is delivered in person over 10 weeks.

Locations

Country Name City State
United States UIC College of Nursing Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Delaware University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in self-efficacy and Stage of Change. A Self-Efficacy Index will be used and Stage of Change individual questions will be used for healthy eating and physical activity. A multi-item index of self-efficacy will be used to examine confidence in making lifestyle changes and in delivering the content. Higher scores represent greater confidence. Stage of change questions will assess CHW motivation (i.e., pre-contemplation, contemplation, preparation) or achievement of eating habit and physical activity behaviors (i.e., action/maintenance stages). Following program completion (10-12 weeks)
Other Adherence Attendance will be measured by a count of the number of training sessions attended. During training sessions (up to 10 weeks).
Primary Change in content knowledge will be measured using the program Knowledge Questionnaire Program content knowledge will be assessed using an adapted version of the original training program knowledge questionnaire. Scores represent the number of content questions answered correctly. Higher scores represent greater program knowledge. Following program completion (10-12 weeks)
Primary Post Training Presentation Delivery Skills Each CHW will be asked to prepare and deliver a brief presentation, including 3 standardized topic areas. Following program completion (10-12 weeks)
Secondary Change in Lifestyle Habits Eating habits will be assessed using the Visually-Enhanced Food Behavior Checklist. Following program completion (10-12 weeks)
Secondary Change in Physical Activity Physical activity will be assessed with International Physical Activity Questionnaire (IPAQ). Following program completion (10-12 weeks)
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