- 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 Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 12
Time Frame: Baseline and 12-weeks post baseline
|
This Self-Efficacy scale was created specifically for this study.
A scale of 19 items includes a list of evidence-based components to a healthy living intervention and asks participants their confidence in implementing these components.
They provide a response ranging from '0-Not at all Confident' to '6-Extremely Confident'.
An average score was taken across all 19 items with a minimum average score of 0 indicating no confidence at all and 6 indicating extreme confidence.
Higher scores are favorable and indicate high self-efficacy in implementing a lifestyle intervention.
|
Baseline and 12-weeks post baseline
|
|
Change in Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 24
Time Frame: Baseline and 24 weeks post baseline
|
This Self-Efficacy scale was created specifically for this study.
A scale of 19 items includes a list of evidence-based components to a healthy living intervention and asks participants their confidence in implementing these components.
They provide a response ranging from '0-Not at all Confident' to '6-Extremely Confident'.
An average score was taken across all 19 items with a minimum average score of 0 indicating no confidence at all and 6 indicating extreme confidence.
Higher scores are favorable and indicate high self-efficacy in implementing a lifestyle intervention.
|
Baseline and 24 weeks post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Obesity Intervention Knowledge Questionnaire at 12 Weeks
Time Frame: Baseline and 12-Weeks post baseline
|
This Obesity Intervention Knowledge scale was created specifically for this study.
A scale of 19 items includes a list of statements related to nutrition, physical activity, and habits to living a healthy lifestyle.
Participants are asked whether the statement is 'True' or 'False' to assess their overall knowledge on healthy living.
The scale is scored by assessing the number of percent items answered correctly, with a minimum percent correct score of 0% indicating no correct responses to 100% correct responses.
Higher scores are favorable and indicate high obesity intervention knowledge.
|
Baseline and 12-Weeks post baseline
|
|
Change in Obesity Intervention Knowledge Questionnaire at 24 Weeks
Time Frame: Baseline and 24-Weeks post baseline
|
This Obesity Intervention Knowledge scale was created specifically for this study.
A scale of 19 items includes a list of statements related to nutrition, physical activity, and habits to living a healthy lifestyle.
Participants are asked whether the statement is 'True' or 'False' to assess their overall knowledge on healthy living.
The scale is scored by assessing the number of percent items answered correctly, with a minimum percent correct score of 0% indicating no correct responses to 100% correct responses.
Higher scores are favorable and indicate high obesity intervention knowledge.
|
Baseline and 24-Weeks post baseline
|
|
Change in Self-Report Skill Mastery at 12 Weeks
Time Frame: Baseline and 12 weeks post baseline
|
This Self-Report skill mastery measure was created specifically for this study.
This measure is comprised of 15 items.
Participants review a case study and then self-report their level of skill mastery of each of the components related to implementing a healthy living intervention.
They provide a response ranging from '0-Strongly Disagree' to '4-Strongly Agree' for each question.
An average score was taken across all 15 items with a minimum average score of 0 indicating they strongly disagree they have skill mastery to 4 indicating they strongly agree they have skill mastery for implementing the healthy living intervention.
Higher scores are favorable and indicate high skill mastery.
|
Baseline and 12 weeks post baseline
|
|
Change in Self-Report Skill Mastery at 24 Weeks
Time Frame: Baseline and 24 weeks post baseline
|
This Self-Report skill mastery measure was created specifically for this study.
This measure is comprised of 15 items.
Participants review a case study and then self-report their level of skill mastery of each of the components related to implementing a healthy living intervention.
They provide a response ranging from '0-Strongly Disagree' to '4-Strongly Agree' for each question.
An average score was taken across all 15 items with a minimum average score of 0 indicating they strongly disagree they have skill mastery to 4 indicating they strongly agree they have skill mastery for implementing the healthy living intervention.
Higher scores are favorable and indicate high skill mastery.
|
Baseline and 24 weeks post baseline
|
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.
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