NCT04125680

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 24, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

October 3, 2019

Results QC Date

September 8, 2022

Last Update Submit

February 22, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Lead Exposure Prevention Knowledge (Pre-Test)

    Baseline

  • Lead Exposure Prevention Knowledge (Post Test)

    Up to 8-weeks post-treatment

  • Health Literacy Level (Pre-Test)

    Baseline

  • Health Literacy Level (Post-Test)

    Up to 8-weeks post-treatment

Other Outcomes (8)

  • Number of Participants Who Experienced Food Insecurity as Measured by the National Health and Nutrition Examination Survey (Pre Test)

    Baseline

  • Number of Participants Who Experienced Food Insecurity as Measured by the National Health and Nutrition Examination Survey (Post Test)

    Up to 8 weeks post treatment

  • Number of Participants Able to Obtain Health Information as Measured by the National Health and Nutrition Examination Survey (Pre Test)

    Baseline

  • +5 more other outcomes

Study Arms (1)

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.

Behavioral: ESL Health Literacy Classes

Interventions

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.

ESL Health Literacy Classes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan - Flint

Flint, Michigan, 48502, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Emily Feuerherm
Organization
University of Michigan

Study Officials

  • Emily Feuerherm, PhD

    University of Michigan-Flint

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Investigator
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 14, 2019

Study Start

May 20, 2021

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

February 24, 2023

Results First Posted

February 24, 2023

Record last verified: 2023-02

Locations