English as a Second Language Health Literacy Program

Health Literacy Clinical Trial

Official title:

Community-Based Participatory English as a Second Language Health Literacy Program to Prevent Lead Exposure in Flint

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125680
• Other study ID #: HUM #00148555
• Secondary ID: UL1TR002240
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: February 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research is using a Community-Based Participatory Action Research (CBPAR) approach to design, implement, and evaluate English as a Second Language health literacy classes for Hispanic adults to reduce lead exposure.

Description:

This Community-Based Participatory Action Research (CBPAR) aims to:

1. 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.

2. Determine the outcomes of the curriculum, including changes in knowledge about lead, access to health resources, and health behavioral changes to reduce lead exposure.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Literacy
• Language

Intervention

Behavioral:
• ESL Health Literacy Classes
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.

Locations

Country	Name	City	State
United States	University of Michigan - Flint	Flint	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	ACE Community Health, Genesee County Hispanic Latino Collaborative, National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Experienced Food Insecurity as Measured by the National Health and Nutrition Examination Survey (Pre Test)	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'.	Baseline
Other	Number of Participants Who Experienced Food Insecurity as Measured by the National Health and Nutrition Examination Survey (Post Test)	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'.	Up to 8 weeks post treatment
Other	Number of Participants Able to Obtain Health Information as Measured by the National Health and Nutrition Examination Survey (Pre Test)	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.	Baseline
Other	Number of Participants Able to Obtain Health Information as Measured by the National Health and Nutrition Examination Survey (Post Test)	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.	Up to 8-weeks post-treatment
Other	Perception of Community Belonging as Measured by the National Health and Nutrition Examination Survey (Pre Test)	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.	Baseline
Other	Perception of Community Belonging as Measured by the National Health and Nutrition Examination Survey (Post Test)	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.	Up to 8 weeks post treatment
Other	Number of Participants With Health Care Coverage as Measured by the Behavioral Risk Factor Surveillance Survey (Pre Test)	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.	Baseline
Other	Number of Participants With Health Care Coverage as Measured by the Behavioral Risk Factor Surveillance Survey (Post Test)	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.	Up to 8 weeks post-treatment
Primary	Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Pre Test)	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
Primary	Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Post Test)	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.	Up to 8-weeks post-treatment
Secondary	Lead Exposure Prevention Knowledge (Pre-Test)	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.	Baseline
Secondary	Lead Exposure Prevention Knowledge (Post Test)	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.	Up to 8-weeks post-treatment
Secondary	Health Literacy Level (Pre-Test)	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
Secondary	Health Literacy Level (Post-Test)	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.	Up to 8-weeks post-treatment