- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04125680
English as a Second Language Health Literacy Program
Community-Based Participatory English as a Second Language Health Literacy Program to Prevent Lead Exposure in Flint
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This Community-Based Participatory Action Research (CBPAR) aims to:
- Develop a community-based participatory English as a Second Language (ESL) health literacy curriculum for lead exposure that can be used in other locations or programs.
- Determine the outcomes of the curriculum, including changes in knowledge about lead, access to health resources, and health behavioral changes to reduce lead exposure.
- To evaluate the implementation of the ESL health literacy curriculum.
This research focuses on ESL health literacy classes provided to Hispanic adults to reduce lead exposure. This research will use a pilot test with a pre-post test design. The program will last for 8 weeks; with weeks 1 and 8 as the assessment weeks. The curriculum uses pedagogies that move participants from health literacy as functional skill to health literacy as social practice where knowledge is used for empowerment and meaningful change. The goals of this research are to demonstrate increased health literacy knowledge, improved health behaviors, increased access to health services, and improved English language proficiency for Hispanic residents of Flint in relation to lead exposure prevention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Flint, Michigan, United States, 48502
- University of Michigan - Flint
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hispanic immigrants living in or around Flint.
- Native speakers of Spanish, with varying degrees of English fluency and literacy.
- 18 years old and older.
Exclusion Criteria:
- Immigrants from other linguistic backgrounds will be excluded at this time because all program materials will be bilingually available in English and Spanish.
- Children will be excluded at this time because we are focusing on ESL health literacy for adults.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ESL Health Literacy Classes
The program will last 8 weeks with classes held online during evening hours.
The curriculum will focus on using pedagogies for health literacy as a practice.
Assessments will be administered pre-post intervention.
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The intervention will last 8-weeks, and the first and last classes will be devoted to survey assessments.
Participants will be asked to reflect on their health knowledge and behaviors, and how they have changed since starting the program.
The curriculum administered during the classes will use pedagogies for health literacy as a practice.
It will focus on skills needed to learn about lead exposure in the ESL classroom: (1) vocabulary; (2) grammar; and (3) identifying risk factors, symptoms and preventive strategies.
A focus on health literacy as practice will include personal engagement using language in context: (1) role-play interactions about lead exposure prevention; (2) discussing views about risk, and how to talk about it with peers and family members; (3) identifying sources of reliable health information; and (4) learning to ask for support and resources.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Pre Test)
Time Frame: Baseline
|
ESL Hispanic adult learners' lead exposure prevention adherence to the evidence-based recommendations set by the Environmental Protection Agency (EPA) and the Centre for Disease Control and Prevention (CDC) for reducing exposure to water containing levels of lead above 15 ppb for the use was measured using a 3 item questionnaire.
Questions include: (1) I have had my water tested for lead; (2) I have an NSF approved filter for my drinking water; and (3) I use bottled water or water from a filtration system for drinking and cooking to reduce or eliminate my lead exposure.
Response options are yes, no and don't know.
The numbers below represent participants who answered 'Yes' to each question.
|
Baseline
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Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Post Test)
Time Frame: Up to 8-weeks post-treatment
|
ESL Hispanic adult learners' lead exposure prevention adherence to the evidence-based recommendations set by the Environmental Protection Agency (EPA) and the Centre for Disease Control and Prevention (CDC) for reducing exposure to water containing levels of lead above 15 ppb for the use was measured using a 3 item questionnaire.
Questions include: (1) I have had my water tested for lead; (2) I have an NSF approved filter for my drinking water; and (3) I use bottled water or water from a filtration system for drinking and cooking to reduce or eliminate my lead exposure.
Response options are yes, no and don't know.
The numbers below represent participants who answered 'Yes' to each question.
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Up to 8-weeks post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lead Exposure Prevention Knowledge (Pre-Test)
Time Frame: Baseline
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ESL Hispanic adult learners' lead exposure prevention knowledge of the evidence-based recommendations set by the EPA and the CDC for reducing exposure to water containing levels of lead above 15 ppb.
Numerical score measured by questions on the Chicago Lead Knowledge Test questionnaire.
Five questions related to the 24 question Chicago Lead Knowledge test questionnaire were administered to participants.
One point was assigned to each correct response.
A participant could earn five total points; with five total points meaning all questions were answered correctly.
A composite value was created for the 5 questions.
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Baseline
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Lead Exposure Prevention Knowledge (Post Test)
Time Frame: Up to 8-weeks post-treatment
|
ESL Hispanic adult learners' lead exposure prevention knowledge of the evidence-based recommendations set by the EPA and the CDC for reducing exposure to water containing levels of lead above 15 ppb.
Numerical score measured by questions on the Chicago Lead Knowledge Test questionnaire.
Five questions related to the 24 question Chicago Lead Knowledge test questionnaire were administered to participants.
One point was assigned to each correct response.
A participant could earn five total points; with five total points meaning all questions were answered correctly.
A composite value was created for the 5 questions.
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Up to 8-weeks post-treatment
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Health Literacy Level (Pre-Test)
Time Frame: Baseline
|
ESL Hispanic adult learner's health literacy score. Numerical score measured by questions on the Fostering Literacy for Good Health Today (FLIGHT) Nive Desarollando Amplia Salud (VIDAS) Test. The short 10-question FLIGHT VIDAS test was administered to participants in Spanish. One point was assigned to each correct response. A participant could earn 10 total points. The literacy level scale is: 0-3 below basic, 4-6 basic, 7-8 intermediate, 9-10 proficient. |
Baseline
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Health Literacy Level (Post-Test)
Time Frame: Up to 8-weeks post-treatment
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ESL Hispanic adult learner's health literacy score.
Numerical score measured by questions on the Fostering Literacy for Good Health Today (FLIGHT) Nive Desarollando Amplia Salud (VIDAS) Test.
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Up to 8-weeks post-treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Experienced Food Insecurity as Measured by the National Health and Nutrition Examination Survey (Pre Test)
Time Frame: Baseline
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ESL Hispanic adult learners' level of food security was measured using two questions from the National Health and Nutrition Examination Survey.
The questions include: (1) In the past 12 months how often did you or anyone else in your household worry there would not be enough to eat because of a lack of money and (2) In the past 12 months how often did you or anyone else in your household not eat quality or variety of foods that you wanted to eat because of a lack of money.
Possible response options include 'Often', 'Sometimes', 'Never', 'Don't Know', and 'Refuse to Answer'.
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Baseline
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Number of Participants Who Experienced Food Insecurity as Measured by the National Health and Nutrition Examination Survey (Post Test)
Time Frame: Up to 8 weeks post treatment
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ESL Hispanic adult learners' level of food security was measured using two questions from the National Health and Nutrition Examination Survey.
The questions include: (1) In the past 12 months how often did you or anyone else in your household worry there would not be enough to eat because of a lack of money and (2) In the past 12 months how often did you or anyone else in your household not eat quality or variety of foods that you wanted to eat because of a lack of money.
Possible response options include 'Often', 'Sometimes', 'Never', 'Don't Know', and 'Refuse to Answer'.
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Up to 8 weeks post treatment
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Number of Participants Able to Obtain Health Information as Measured by the National Health and Nutrition Examination Survey (Pre Test)
Time Frame: Baseline
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ESL Hispanic adult learners' completed three questions to evaluate their ability to obtain health information.
Three questions taken from the National Health and Nutrition Examination Survey were administered to participants.
Questions include (1) In the past 12 months did you do anything to improve your health (2) In the past 12 months have you required health information or advice for yourself or a family member and (3) In the past 12 months did you ever experience any difficulties getting the health information or advice for yourself or a family member.
Response options are yes, no and don't know.
The numbers below represent participants who answered 'Yes' to each question.
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Baseline
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Number of Participants Able to Obtain Health Information as Measured by the National Health and Nutrition Examination Survey (Post Test)
Time Frame: Up to 8-weeks post-treatment
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ESL Hispanic adult learners' completed three questions to evaluate their ability to obtain health information.
Three questions taken from the National Health and Nutrition Examination Survey were administered to participants.
Questions include (1) In the past 12 months did you do anything to improve your health (2) In the past 12 months have you required health information or advice for yourself or a family member and (3) In the past 12 months did you ever experience any difficulties getting the health information or advice for yourself or a family member.
Response options are yes, no and don't know.
The numbers below represent participants who answered 'Yes' to each question.
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Up to 8-weeks post-treatment
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Perception of Community Belonging as Measured by the National Health and Nutrition Examination Survey (Pre Test)
Time Frame: Baseline
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ESL Hispanic adult learners' were asked to describe their sense of belonging to thier local community.
Participants were asked to complete a question taken from the National Health and Nutrition Examination Survey asking them to rate their sense of belonging to their local community from 'very strong' (1) to 'very weak' (4).
Responses could include 'very strong','somewhat strong', 'somewhat weak', 'very weak', 'don't know', and 'refuse to answer'.
The numbers below represent the participants who selected each response.
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Baseline
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Perception of Community Belonging as Measured by the National Health and Nutrition Examination Survey (Post Test)
Time Frame: Up to 8 weeks post treatment
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ESL Hispanic adult learners' were asked to describe their sense of belonging to thier local community.
Participants were asked to complete a question taken from the National Health and Nutrition Examination Survey asking them to rate their sense of belonging to their local community from 'very strong' (1) to 'very weak' (4).
Responses could include 'very strong','somewhat strong', 'somewhat weak', 'very weak', 'don't know', and 'refuse to answer'.
The numbers below represent the participants who selected each response.
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Up to 8 weeks post treatment
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Number of Participants With Health Care Coverage as Measured by the Behavioral Risk Factor Surveillance Survey (Pre Test)
Time Frame: Baseline
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ESL Hispanic adult learners' were asked to describe their health care coverage status.
Numerical score measured by questions on the Behavioral Risk Factor Surveillance Survey.
Participants were asked (1) Do you have any kind of health case coverage including health insurance, prepaid plans such as HMOs, or government plans such as Medicare, or Indian Health Service?
Responses could include 'Yes', 'No' and 'Don't Know'.
The participants who answered 'Yes' are represented below.
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Baseline
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Number of Participants With Health Care Coverage as Measured by the Behavioral Risk Factor Surveillance Survey (Post Test)
Time Frame: Up to 8 weeks post-treatment
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ESL Hispanic adult learners' were asked to describe their health care coverage status.
Numerical score measured by questions on the Behavioral Risk Factor Surveillance Survey.
Participants were asked (1) Do you have any kind of health case coverage including health insurance, prepaid plans such as HMOs, or government plans such as Medicare, or Indian Health Service?
Responses could include 'Yes', 'No' and 'Don't Know'.
The participants who answered 'Yes' are represented below.
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Up to 8 weeks post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily Feuerherm, PhD, University of Michigan-Flint
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
Other Study ID Numbers
- HUM #00148555
- UL1TR002240 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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