Trial Outcomes & Findings for A Web-Based Healthy Living Training for Promotores (NCT NCT06627439)

NCT ID: NCT06627439

Last Updated: 2026-07-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

160 participants

Primary outcome timeframe

Baseline and 12-weeks post baseline

Results posted on

2026-07-22

Participant Flow

Participant milestones

Participant milestones
Measure
Comadres Saludables CHW Training
Experimental group participants will have access to the web-based Comadres Saludables training for three months. Comadres 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.
Control
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. Control: 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.
Overall Study
STARTED
80
80
Overall Study
COMPLETED
67
70
Overall Study
NOT COMPLETED
13
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Comadres Saludables CHW Training
n=80 Participants
Experimental group participants will have access to the web-based Comadres Saludables training for three months. Comadres 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.
Control
n=80 Participants
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. Control: 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.
Total
n=160 Participants
Total of all reporting groups
Age, Continuous
44.61 years
STANDARD_DEVIATION 10.33 • n=80 Participants
48.29 years
STANDARD_DEVIATION 12.37 • n=80 Participants
46.44 years
STANDARD_DEVIATION 11.50 • n=160 Participants
Sex: Female, Male
Female
80 Participants
n=80 Participants
80 Participants
n=80 Participants
160 Participants
n=160 Participants
Sex: Female, Male
Male
0 Participants
n=80 Participants
0 Participants
n=80 Participants
0 Participants
n=160 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latino
70 Participants
n=80 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
72 Participants
n=79 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
142 Participants
n=159 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
8 Participants
n=80 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
5 Participants
n=79 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
13 Participants
n=159 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
Race/Ethnicity, Customized
Race/Ethnicity · White
1 Participants
n=80 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
2 Participants
n=79 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
3 Participants
n=159 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
Race/Ethnicity, Customized
Race/Ethnicity · American Indian/Alaskan Native
1 Participants
n=80 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
0 Participants
n=79 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
1 Participants
n=159 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian/Other Pacific Islander
0 Participants
n=80 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
0 Participants
n=79 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
0 Participants
n=159 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
Race/Ethnicity, Customized
Race/Ethnicity · Other
0 Participants
n=80 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
0 Participants
n=79 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
0 Participants
n=159 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
Race/Ethnicity, Customized
Race/Ethnicity · Asian
0 Participants
n=80 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
0 Participants
n=79 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
0 Participants
n=159 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
Self-Efficacy in Core Lifestyle Intervention Learning Components
5.33 units on a scale
STANDARD_DEVIATION 1.04 • n=80 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
4.9 units on a scale
STANDARD_DEVIATION 1.06 • n=79 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.
5.12 units on a scale
STANDARD_DEVIATION 1.07 • n=159 Participants • Due to missing data and/or "prefer not to answer" option within the study survey and procedures, the total number of participants analyzed for this descriptive variable is less than the N=180.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Comadres Saludables CHW Training
n=73 Participants
Experimental group participants will have access to the web-based Comadres Saludables training for three months. Comadres 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.
Control
n=70 Participants
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. Control: 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.
Change in Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 12
Baseline Self-Efficacy
5.32 Total Score
Standard Deviation 1.06
4.88 Total Score
Standard Deviation 1.08
Change in Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 12
12-weeks post baseline Self Efficacy
5.36 Total Score
Standard Deviation 0.96
5.08 Total Score
Standard Deviation 1.08

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Comadres Saludables CHW Training
n=67 Participants
Experimental group participants will have access to the web-based Comadres Saludables training for three months. Comadres 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.
Control
n=68 Participants
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. Control: 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.
Change in Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 24
Baseline Self-Efficacy
5.32 Total score
Standard Deviation 1.04
4.87 Total score
Standard Deviation 1.09
Change in Self-Efficacy in Core Lifestyle Intervention Learning Components at Week 24
24 weeks post baseline Self-Efficacy
5.63 Total score
Standard Deviation 0.83
5.20 Total score
Standard Deviation 0.90

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Comadres Saludables CHW Training
n=73 Participants
Experimental group participants will have access to the web-based Comadres Saludables training for three months. Comadres 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.
Control
n=71 Participants
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. Control: 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.
Change in Obesity Intervention Knowledge Questionnaire at 12 Weeks
Baseline Knowledge
74.30 Total score
Standard Deviation 12.5
73.44 Total score
Standard Deviation 14.37
Change in Obesity Intervention Knowledge Questionnaire at 12 Weeks
12-weeks post baseline knowledge
78.25 Total score
Standard Deviation 11.90
76.05 Total score
Standard Deviation 14.80

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Comadres Saludables CHW Training
n=67 Participants
Experimental group participants will have access to the web-based Comadres Saludables training for three months. Comadres 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.
Control
n=69 Participants
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. Control: 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.
Change in Obesity Intervention Knowledge Questionnaire at 24 Weeks
24-weeks post baseline knowledge
77.74 Total score
Standard Deviation 12.04
76.28 Total score
Standard Deviation 12.10
Change in Obesity Intervention Knowledge Questionnaire at 24 Weeks
Baseline Knowledge
73.57 Total score
Standard Deviation 12.50
73.66 Total score
Standard Deviation 14.20

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Comadres Saludables CHW Training
n=73 Participants
Experimental group participants will have access to the web-based Comadres Saludables training for three months. Comadres 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.
Control
n=71 Participants
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. Control: 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.
Change in Self-Report Skill Mastery at 12 Weeks
Baseline Self Report Skill Mastery
3.29 Total score
Standard Deviation 0.61
3.10 Total score
Standard Deviation 0.50
Change in Self-Report Skill Mastery at 12 Weeks
12 Weeks post baseline self report skill mastery
3.35 Total score
Standard Deviation 0.50
3.17 Total score
Standard Deviation 0.55

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Comadres Saludables CHW Training
n=66 Participants
Experimental group participants will have access to the web-based Comadres Saludables training for three months. Comadres 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.
Control
n=69 Participants
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. Control: 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.
Change in Self-Report Skill Mastery at 24 Weeks
Baseline Self Report Skill Mastery
3.27 Total score
Standard Deviation 0.62
3.10 Total score
Standard Deviation 0.49
Change in Self-Report Skill Mastery at 24 Weeks
24 Weeks post baseline self report skill mastery
3.44 Total score
Standard Deviation 0.45
3.24 Total score
Standard Deviation 0.46

Adverse Events

Comadres Saludables CHW Training

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Debra Rios

ISA Associates, Inc.

Phone: 7037390462

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place