Diabetes Mellitus RiskNCT04161846
Virtual World Training for Community Health Workers (CHW)
A study testing Virtual Training and In Person Training in people with Diabetes Mellitus Risk, run by University of Delaware at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Risk
- What is being tested?
- Virtual Training and In Person Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 25 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus Risk
- Being tested
- Virtual Training, In Person Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual TrainingBehavioural
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 TrainingBehavioural
The intervention involves a CHW training focused on raising awareness of diabetes prevention in the community. It is delivered in person over 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Virtual World Program | Experimental | Participants take part in a group training delivered using a virtual world approach. Receives: Behavioral: Virtual Training |
| In Person Program | Active comparator | Participants take part in a group training delivered using an in person approach. Receives: Behavioral: In Person Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Following program completion (10-12 weeks)
Secondary outcomes (2)
Change in Lifestyle Habits
Eating habits will be assessed using the Visually-Enhanced Food Behavior Checklist.
Measured: Following program completion (10-12 weeks)
Change in Physical Activity
Physical activity will be assessed with International Physical Activity Questionnaire (IPAQ).
Measured: Following program completion (10-12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start8 Aug 2019
- Primary completion25 Apr 2021
- Study completion25 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 2 group repeated measures design (Pre-Pandemic) \[Pandemic modification: Only Virtual world group\]
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago
- Responsible party
- Principal investigator, Laurie Ruggiero, Ph.D., University of Delaware
- Investigators
- Laurie Ruggiero, Ph.D, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161846
- Sponsor's protocol ID
- 1106606-8
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2019
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Racial/Ethnic Minority Communities to Support Healthy Lifestyle Change: Virtual World Training for Community Health Workers
- ClinicalTrials.gov ID
- NCT04161846
- Acronym / sponsor ID
- 1106606-8
- Conditions
- Diabetes Mellitus Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- University of Illinois Chicago
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 25 Apr 2021 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized 2 group repeated measures design (Pre-Pandemic) [Pandemic modification: Only Virtual world group]
| Arm | Type | Receives |
|---|---|---|
| Virtual World Program | Experimental | Behavioral: Virtual TrainingParticipants take part in a group training delivered using a virtual world approach. |
| In Person Program | Active comparator | Behavioral: In Person TrainingParticipants take part in a group training delivered using an in person approach. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual TrainingThe 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. | Behavioural | Virtual World Program |
| In Person TrainingThe intervention involves a CHW training focused on raising awareness of diabetes prevention in the community. It is delivered in person over 10 weeks. | Behavioural | In Person Program |
Primary outcome
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.
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.
2 secondary outcomes
Change in Lifestyle Habits
Time frame: Following program completion (10-12 weeks)
Change in Physical Activity
Time frame: Following program completion (10-12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Ruggiero, Ph.D principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Training and In Person Training in people with Diabetes Mellitus Risk, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in content knowledge will be measured using the program Knowledge Questionnaire (time frame: Following program completion (10-12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.