Health LiteracyNCT04125680

English as a Second Language Health Literacy Program

A study testing ESL Health Literacy Classes in people with Health Literacy and Language, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Health Literacy, Language
What is being tested?: ESL Health Literacy Classes
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 20 May 2021to 15 Sep 2021
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 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Hispanic immigrants living in or around Flint.
Native speakers of Spanish, with varying degrees of English fluency and literacy.
18 years old and older.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan - Flint
Flint, Michigan, 48502

Other trials in United States

About this study

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

Read the 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.

Conditions: Health Literacy, Language
Being tested: ESL Health Literacy Classes
Medical subject headings: Language

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ESL Health Literacy ClassesBehavioural
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.

Study groups in NCT04125680
Study group	Role	What they receive
ESL Health Literacy Classes	Other	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. Receives: Behavioral: ESL Health Literacy Classes

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline
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.
Measured: Up to 8-weeks post-treatment

Secondary outcomes (4)

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.
Measured: Baseline
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.
Measured: Up to 8-weeks post-treatment
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.
Measured: Baseline
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.
Measured: Up to 8-weeks post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202115 Sep 2021

First posted14 Oct 2019
Study start20 May 2021
Primary completion15 Sep 2021
Study completion15 Sep 2021

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Health LiteracyStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Model description: A pilot trial will be used: study participants will be registered and placed into the program on a first-come, first-served basis. This will result in a study assessing correlation rather than causation.
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04125680
Sponsor's protocol ID: HUM #00148555
Other IDs: UL1TR002240
Status last verified: Feb 2023
First submitted: 3 Oct 2019
Last updated: 24 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Baumeister A, Aldin A, Chakraverty D, Hubner C, Adams A, Monsef I, Skoetz N, Kalbe E, Woopen C. Interventions for improving health literacy in migrants. Cochrane Database Syst Rev. 2023 Nov 14;11(11):CD013303. doi: 10.1002/14651858.CD013303.pub2.
PubMed 37963101

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community-Based Participatory English as a Second Language Health Literacy Program to Prevent Lead Exposure in Flint
ClinicalTrials.gov ID: NCT04125680
Acronym / sponsor ID: HUM #00148555
Conditions: Health Literacy, Language
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: ACE Community Health, Genesee County Hispanic Latino Collaborative, National Center for Advancing Translational Sciences (NCATS)
Study start: 20 May 2021 (actual)
Primary completion: 15 Sep 2021 (actual)
Study completion: 15 Sep 2021 (actual)
First posted: 14 Oct 2019 (actual)
Results: Posted 24 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A pilot trial will be used: study participants will be registered and placed into the program on a first-come, first-served basis. This will result in a study assessing correlation rather than causation.

Arm	Type	Receives
ESL Health Literacy Classes	Other	Behavioral: ESL Health Literacy ClassesThe 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.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Hispanic immigrants living in or around Flint.
Native speakers of Spanish, with varying degrees of English fluency and literacy.
18 years old and older.

Key exclusion criteria (2 listed)

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.

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
ESL Health Literacy ClassesThe 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.	Behavioural	ESL Health Literacy Classes

Primary outcome

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.
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.

4 secondary outcomes

Lead Exposure Prevention Knowledge (Pre-Test)
Time frame: Baseline
Lead Exposure Prevention Knowledge (Post Test)
Time frame: Up to 8-weeks post-treatment
Health Literacy Level (Pre-Test)
Time frame: Baseline
Health Literacy Level (Post-Test)
Time frame: Up to 8-weeks post-treatment

Results and safety

Results posted to the registry on 24 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ESL Health Literacy Classes	17	2

Primary outcome: Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Pre Test)

Time frame: Baseline. Count of participants. Unit: Participants

Measure	ESL Health Literacy Classes n = 5
I have had my water tested for lead.	1
I have an NSF-approved filter for my drinking water.	2
I use bottled water or water from a filtration system to reduce or eliminate my lead exposure	5

Population analysed: Five people participated in the health literacy curriculum which is where this outcome was measured.

Primary outcome: Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Post Test)

Time frame: Up to 8-weeks post-treatment. Count of participants. Unit: Participants

Measure	ESL Health Literacy Classes n = 5
I have had my water tested for lead.	3
I have an NSF-approved filter for my drinking water.	5
I use bottled water or water from a filtration system to reduce or eliminate my lead exposure	5

Population analysed: Five people participated in the health literacy curriculum which is where this outcome was measured.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ESL Health Literacy Classes	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): The main limitation to this study was low enrollment: (1) it was moved online for the pandemic and they preferred in-person, (2) they did not have time or technology to join the online program, and/or (3) interest had waned because of pandemic-related delays, or community-internal politics made some people distrust the community partner.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37963101Baumeister A, Aldin A, Chakraverty D, Hubner C, Adams A, Monsef I, Skoetz N, Kalbe E, Woopen C. Interventions for improving health literacy in migrants. Cochrane Database Syst Rev. 2023 Nov 14;11(11):CD013303. doi: 10.1002/14651858.CD013303.pub2.

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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.

Emily Feuerherm, PhD principal investigator

University of Michigan-Flint

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ESL Health Literacy Classes in people with Health Literacy and Language, run by University of Michigan 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 3 inclusion and 2 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 24 Feb 2023. 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 24 Feb 2023). 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?

Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Pre Test) (time frame: 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?

On the ClinicalTrials.gov record for NCT04125680, which also lists 1 linked publication.

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 24 Feb 2023.