NCT04161846

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2021

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

1.7 years

First QC Date

June 18, 2019

Last Update Submit

June 4, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (2)

  • Change in Lifestyle Habits

    Following program completion (10-12 weeks)

  • Change in Physical Activity

    Following program completion (10-12 weeks)

Other Outcomes (2)

  • 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.

    Following program completion (10-12 weeks)

  • Adherence

    During training sessions (up to 10 weeks).

Study Arms (2)

Virtual World Program

EXPERIMENTAL

Participants take part in a group training delivered using a virtual world approach.

Behavioral: Virtual Training

In Person Program

ACTIVE COMPARATOR

Participants take part in a group training delivered using an in person approach.

Behavioral: In Person Training

Interventions

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.

Virtual World Program

The intervention involves a CHW training focused on raising awareness of diabetes prevention in the community. It is delivered in person over 10 weeks.

In Person Program

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale Only
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • community health worker
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UIC College of Nursing

Chicago, Illinois, 60612, United States

Location

Study Officials

  • Laurie Ruggiero, Ph.D

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized 2 group repeated measures design (Pre-Pandemic) \[Pandemic modification: Only Virtual world group\]
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2019

First Posted

November 13, 2019

Study Start

August 8, 2019

Primary Completion

April 25, 2021

Study Completion

April 25, 2021

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations