- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06627439
A Web-Based Healthy Living Training for Promotores
Comadres Saludables: A Web-Based Promotora Training Program for Obesity Prevention in Hispanic Women
The goal of this clinical trial is to test a new web-based promotora de salud/ community health worker (CHW) training. This training is designed to provide CHWs with the knowledge and skills to effectively implement a healthy living intervention for Latinas. The main question it aims to answer is:
o Do CHWs who complete the web-based healthy living training have higher self-efficacy in implementing core lifestyle intervention learning components for obesity interventions in Hispanics than CHWs who do not?
Participants will:
- Complete a baseline survey asking about self-efficacy related to implementing core lifestyle intervention learning components, knowledge, health behaviors, and skill mastery.
- Be randomized to receive the new web-based training or to a standard CHW training designed by Health and Human Services. The new web-based training provides promotores with the self-efficacy, knowledge, and skills required to effectively implement an obesity intervention for Hispanic women. Promotores will build their skillset through interactive quizzes, exercises, video role-playing scenarios, and interactive tools.
- Complete follow-up surveys at 3 months and 6 months after the baseline survey. This survey will ask the same questions as the baseline survey and will include additional questions regarding satisfaction with training and behavior application.
Researchers will compare participants who receive the new web-based training to participants who utilize the HHS training. The goal is to see whether the new web-based training increases self-efficacy among CHWs to effectively implement core lifestyle learning components for obesity interventions in Hispanics.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Arlington, Virginia, United States, 22203
- ISA Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age and old
- Comfortable speaking, reading, and writing English OR Spanish
- Female
- Access to a computer that has internet
- Not Pregnant
- Have a community health worker certification through the state of TX OR have worked over 6 moths as a community health worker and meets core competencies for CHWs
- Provides services to Hispanic populations
Exclusion Criteria:
- Less than 18 years of age and old
- Not comfortable speaking, reading, and writing English OR Spanish
- Male
- Does not have access to a computer that has internet
- Pregnant
- Does not have a community health worker certification through the state of TX OR have not worked over 6 moths as a community health worker and does not meet core competencies for CHWs
- Does not provide services to Hispanic populations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-based Comadres Saludables CHW Training
Experimental group participants will have access to the web-based Comadres Saludables training for three months.
|
Comadres Saludables is a web-based healthy living training for community health workers aimed at addressing obesity in Latinas.
Comadres Saludables will combine both theory and evidence-based practices to provide participants with the self-efficacy, knowledge, and skills required to effectively implement an obesity intervention for Hispanic women.
Participants (CHWs) will build their skillset through interactive quizzes, exercises, and video role-playing scenarios.
Additionally, Comadres Saludables allows participants to utilize interactive mHealth tools to enhance implementation with Hispanic women.
Participants will access the training for three months.
|
|
Active Comparator: HHS Promoting Healthy Choices and Community Changes
Control condition participants will receive information on how to access the HHS CHW Promoting Healthy Choices and Community Changes training.
They will be asked to review for three months.
|
Participants will access the web-based HHS Promoting Healthy Choices and Community Changes that includes a variety of content via text, audio, and video.
The information is designed to educate CHWs on how to implement health interventions for positive community change.
They are asked to review it for three months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Baseline Self-Efficacy at week 12 and week 24
Time Frame: Baseline, Week 12, and Week 24
|
19-item questionnaire that measures the degree to which an individual perceives self efficacy in implementing core lifestyle intervention learning components for obesity interventions in Hispanics.
Score ranges from 19-133 with a higher score indicating higher self-efficacy.
|
Baseline, Week 12, and Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Obesity Intervention Knowledge Questionnaire
Time Frame: Baseline, Week 12, and Week 24
|
Measured using 40 questions developed specifically for the proposed study.
Items measure knowledge acquired about the healthy living intervention and are averaged to form a score ranging from 1 to 40, where higher scores indicate higher knowledge.
|
Baseline, Week 12, and Week 24
|
|
Self-Report Skill Mastery
Time Frame: Baseline, Week 12, and Week 24
|
Measured using 15-items that assess self-report skill mastery across three scenarios.
Participants rate their skill mastery on a scale of 1 (strongly disagree) to 5 (strongly agree) they have the skills to performs specific tasks.
Score ranges from 5 to 75 with higher scores indicating higher self-report skill mastery.
|
Baseline, Week 12, and Week 24
|
|
Satisfaction with Training
Time Frame: Week 12
|
Measured using 21-items that assess an individuals satisfaction with using the web-based CHW training.
Score ranges from 21 to 105 with higher scores indicating higher satisfaction.
|
Week 12
|
|
Behavior Application
Time Frame: Week 24
|
Measured using 20-items that assess whether an individual has utilized the knowledge and skills learned in the training in their day-to-day work life.
Score ranges from 20 to 100 with higher scores indicating higher usage of the knowledge and skills.
|
Week 24
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Debra M Rios, DrPH, ISA Associates
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44MD016228 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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