An interventional study of Comadres Saludables and Control in Obesity Prevention, sponsored by ISA Associates, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by ISA Associates, Inc. · Not applicable, Interventional, and Prevention
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:
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 160 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →ISA Associates, Inc. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Experimental group participants will have access to the web-based Comadres Saludables training for three months.
Behavioral: Comadres Saludables
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.
Behavioral: Control
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.
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
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.
Time frame: 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.
Time frame: Baseline and 24 weeks post baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 24 weeks post baseline
| Milestone | Comadres Saludables CHW Training | Control |
|---|---|---|
| Started | 80 | 80 |
| Completed | 67 | 70 |
| Not completed | 13 | 10 |
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.
| Total Score | Comadres Saludables CHW Training | Control |
|---|---|---|
| Baseline Self-Efficacy | 5.32 ± 1.06 | 4.88 ± 1.08 |
| 12-weeks post baseline Self Efficacy | 5.36 ± 0.96 | 5.08 ± 1.08 |
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.
| Total score | Comadres Saludables CHW Training | Control |
|---|---|---|
| Baseline Self-Efficacy | 5.32 ± 1.04 | 4.87 ± 1.09 |
| 24 weeks post baseline Self-Efficacy | 5.63 ± 0.83 | 5.20 ± 0.90 |
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.
| Total score | Comadres Saludables CHW Training | Control |
|---|---|---|
| Baseline Knowledge | 74.30 ± 12.5 | 73.44 ± 14.37 |
| 12-weeks post baseline knowledge | 78.25 ± 11.90 | 76.05 ± 14.80 |
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.
| Total score | Comadres Saludables CHW Training | Control |
|---|---|---|
| Baseline Knowledge | 73.57 ± 12.50 | 73.66 ± 14.20 |
| 24-weeks post baseline knowledge | 77.74 ± 12.04 | 76.28 ± 12.10 |
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.
| Total score | Comadres Saludables CHW Training | Control |
|---|---|---|
| Baseline Self Report Skill Mastery | 3.29 ± 0.61 | 3.10 ± 0.50 |
| 12 Weeks post baseline self report skill mastery | 3.35 ± 0.50 | 3.17 ± 0.55 |
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.
| Total score | Comadres Saludables CHW Training | Control |
|---|---|---|
| Baseline Self Report Skill Mastery | 3.27 ± 0.62 | 3.10 ± 0.49 |
| 24 Weeks post baseline self report skill mastery | 3.44 ± 0.45 | 3.24 ± 0.46 |
Collected over From enrollment until 24 weeks post baseline.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Comadres Saludables CHW Training | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
| Control | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
| Age, Continuous(years) | Comadres Saludables CHW Training | Control | Total |
|---|---|---|---|
| Mean | 44.61 ± 10.33 | 48.29 ± 12.37 | 46.44 ± 11.50 |
| Sex: Female, Male(Participants) | Comadres Saludables CHW Training | Control | Total |
|---|---|---|---|
| Female | 80 | 80 | 160 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Comadres Saludables CHW Training | Control | Total |
|---|---|---|---|
| Race/Ethnicity — Hispanic/Latino | 70 | 72 | 142 |
| Race/Ethnicity — Black/African American | 8 | 5 | 13 |
| Race/Ethnicity — White | 1 | 2 | 3 |
| Race/Ethnicity — American Indian/Alaskan Native | 1 | 0 | 1 |
| Race/Ethnicity — Native Hawaiian/Other Pacific Islander | 0 | 0 | 0 |
| Race/Ethnicity — Other | 0 | 0 | 0 |
| Race/Ethnicity — Asian | 0 | 0 | 0 |
| Self-Efficacy in Core Lifestyle Intervention Learning Components(units on a scale) | Comadres Saludables CHW Training | Control | Total |
|---|---|---|---|
| Mean | 5.33 ± 1.04 | 4.9 ± 1.06 | 5.12 ± 1.07 |
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ISA Associates, Inc.