- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04161846
Virtual World Training for Community Health Workers (CHW)
June 4, 2021 updated by: Laurie Ruggiero, Ph.D., University of Delaware
Reaching Racial/Ethnic Minority Communities to Support Healthy Lifestyle Change: Virtual World Training for Community Health Workers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- UIC College of Nursing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual World Program
Participants take part in a group training delivered using a virtual world approach.
|
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.
|
|
Active Comparator: In Person Program
Participants take part in a group training delivered using an in person approach.
|
The intervention involves a CHW training focused on raising awareness of diabetes prevention in the community.
It is delivered in person over 10 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in content knowledge will be measured using the program Knowledge Questionnaire
Time Frame: Following program completion (10-12 weeks)
|
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)
|
|
Post Training Presentation Delivery Skills
Time Frame: Following program completion (10-12 weeks)
|
Each CHW will be asked to prepare and deliver a brief presentation, including 3 standardized topic areas.
|
Following program completion (10-12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Lifestyle Habits
Time Frame: Following program completion (10-12 weeks)
|
Eating habits will be assessed using the Visually-Enhanced Food Behavior Checklist.
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Following program completion (10-12 weeks)
|
|
Change in Physical Activity
Time Frame: Following program completion (10-12 weeks)
|
Physical activity will be assessed with International Physical Activity Questionnaire (IPAQ).
|
Following program completion (10-12 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: Following program completion (10-12 weeks)
|
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)
|
|
Adherence
Time Frame: During training sessions (up to 10 weeks).
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Attendance will be measured by a count of the number of training sessions attended.
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During training sessions (up to 10 weeks).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurie Ruggiero, Ph.D, University of Delaware
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2019
Primary Completion (Actual)
April 25, 2021
Study Completion (Actual)
April 25, 2021
Study Registration Dates
First Submitted
June 18, 2019
First Submitted That Met QC Criteria
November 10, 2019
First Posted (Actual)
November 13, 2019
Study Record Updates
Last Update Posted (Actual)
June 9, 2021
Last Update Submitted That Met QC Criteria
June 4, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1106606-8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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