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A Web-Based Healthy Living Training for Promotores

Comadres Saludables: A Web-Based Promotora Training Program for Obesity Prevention in Hispanic Women

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06627439
Enrollment
160
Registered
2024-10-04
Start date
2024-09-13
Completion date
2025-09-30
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Prevention

Keywords

Obesity, Latina

Brief summary

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.

Interventions

BEHAVIORALComadres Saludables

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.

BEHAVIORALControl

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.

Sponsors

ISA Associates, Inc.
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 12Baseline and 12-weeks post baselineThis 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.
Change in Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 24Baseline and 24 weeks post baselineThis 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.

Secondary

MeasureTime frameDescription
Change in Obesity Intervention Knowledge Questionnaire at 12 WeeksBaseline and 12-Weeks post baselineThis 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.
Change in Obesity Intervention Knowledge Questionnaire at 24 WeeksBaseline and 24-Weeks post baselineThis 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.
Change in Self-Report Skill Mastery at 12 WeeksBaseline and 12 weeks post baselineThis 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.
Change in Self-Report Skill Mastery at 24 WeeksBaseline and 24 weeks post baselineThis 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDebra M Rios, DrPH

ISA Associates

Baseline characteristics

Characteristic
Age, Continuous44.61 years
STANDARD_DEVIATION 10.33
Race/Ethnicity, Customized
Race/Ethnicity
American Indian/Alaskan Native
1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Asian
0 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Black/African American
8 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic/Latino
142 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Native Hawaiian/Other Pacific Islander
0 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other
0 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White
3 Participants
Self-Efficacy in Core Lifestyle Intervention Learning Components4.9 units on a scale
STANDARD_DEVIATION 1.06
Sex: Female, Male
Female
80 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 800 / 80
other
Total, other adverse events
0 / 800 / 80
serious
Total, serious adverse events
0 / 800 / 80

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026