Obesity PreventionNCT06627439
A Web-Based Healthy Living Training for Promotores
A study testing Comadres Saludables in people with Obesity Prevention, run by ISA Associates, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention
- What is being tested?
- Comadres Saludables
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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?
Read more
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.
- Conditions
- Obesity Prevention
- Being tested
- Comadres Saludables, Control
- Keywords
- Obesity, Latina
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comadres SaludablesBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based Comadres Saludables CHW Training | Experimental | Experimental group participants will have access to the web-based Comadres Saludables training for three months. Receives: Behavioral: Comadres Saludables |
| HHS Promoting Healthy Choices and Community Changes | Active comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 12
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.
Measured: Baseline and 12-weeks post baseline
Change in Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 24
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.
Measured: Baseline and 24 weeks post baseline
Secondary outcomes (4)
Change in Obesity Intervention Knowledge Questionnaire at 12 Weeks
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.
Measured: Baseline and 12-Weeks post baseline
Change in Obesity Intervention Knowledge Questionnaire at 24 Weeks
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.
Measured: Baseline and 24-Weeks post baseline
Change in Self-Report Skill Mastery at 12 Weeks
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.
Measured: Baseline and 12 weeks post baseline
Change in Self-Report Skill Mastery at 24 Weeks
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.
Measured: Baseline and 24 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start13 Sep 2024
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity PreventionStudies 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
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- ISA Associates, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Debra M Rios, DrPH, Principal investigator, ISA Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627439
- Sponsor's protocol ID
- R44MD016228
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2024
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comadres Saludables: A Web-Based Promotora Training Program for Obesity Prevention in Hispanic Women
- ClinicalTrials.gov ID
- NCT06627439
- Acronym / sponsor ID
- R44MD016228
- Conditions
- Obesity Prevention
- Keywords
- Obesity, Latina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- ISA Associates, Inc.University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Posted 22 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based Comadres Saludables CHW Training | Experimental | Behavioral: Comadres SaludablesExperimental group participants will have access to the web-based Comadres Saludables training for three months. |
| HHS Promoting Healthy Choices and Community Changes | Active comparator | Behavioral: ControlControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age and old
- Comfortable speaking, reading, and writing English OR Spanish
- Female
- Access to a computer that has internet
- Not Pregnant
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Comadres SaludablesComadres 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. | Behavioural | Web-based Comadres Saludables CHW Training |
| ControlParticipants 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. | Behavioural | HHS Promoting Healthy Choices and Community Changes |
Primary outcome
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.
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.
4 secondary outcomes
Change in Obesity Intervention Knowledge Questionnaire at 12 Weeks
Time frame: Baseline and 12-Weeks post baseline
Change in Obesity Intervention Knowledge Questionnaire at 24 Weeks
Time frame: Baseline and 24-Weeks post baseline
Change in Self-Report Skill Mastery at 12 Weeks
Time frame: Baseline and 12 weeks post baseline
Change in Self-Report Skill Mastery at 24 Weeks
Time frame: Baseline and 24 weeks post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Debra M Rios, DrPH principal investigator
ISA Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comadres Saludables in people with Obesity Prevention, run by ISA Associates, Inc. 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 7 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 22 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 12 (time frame: Baseline and 12-weeks post baseline). 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 22 Jul 2026.