Clinical trial NCT04125680: English as a Second Language Health Literacy Program
Official title: Community-Based Participatory English as a Second Language Health Literacy Program to Prevent Lead Exposure in Flint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Language
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: ACE Community Health
name: Genesee County Hispanic Latino Collaborative
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-10-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Pre Test)
timeFrame: Baseline
measure: Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Post Test)
timeFrame: Up to 8-weeks post-treatment
Secondary outcomes:
measure: Lead Exposure Prevention Knowledge (Pre-Test)
timeFrame: Baseline
measure: Lead Exposure Prevention Knowledge (Post Test)
timeFrame: Up to 8-weeks post-treatment
measure: Health Literacy Level (Pre-Test)
timeFrame: Baseline
measure: Health Literacy Level (Post-Test)
timeFrame: Up to 8-weeks post-treatment
Other outcomes:
measure: Number of Participants Who Experienced Food Insecurity as Measured by the National Health and Nutrition Examination Survey (Pre Test)
timeFrame: Baseline
measure: Number of Participants Who Experienced Food Insecurity as Measured by the National Health and Nutrition Examination Survey (Post Test)
timeFrame: Up to 8 weeks post treatment
measure: Number of Participants Able to Obtain Health Information as Measured by the National Health and Nutrition Examination Survey (Pre Test)
timeFrame: Baseline
measure: Number of Participants Able to Obtain Health Information as Measured by the National Health and Nutrition Examination Survey (Post Test)
timeFrame: Up to 8-weeks post-treatment
measure: Perception of Community Belonging as Measured by the National Health and Nutrition Examination Survey (Pre Test)
timeFrame: Baseline
measure: Perception of Community Belonging as Measured by the National Health and Nutrition Examination Survey (Post Test)
timeFrame: Up to 8 weeks post treatment
measure: Number of Participants With Health Care Coverage as Measured by the Behavioral Risk Factor Surveillance Survey (Pre Test)
timeFrame: Baseline
measure: Number of Participants With Health Care Coverage as Measured by the Behavioral Risk Factor Surveillance Survey (Post Test)
timeFrame: Up to 8 weeks post-treatment
Locations:
city: Flint
country: United States
facility: University of Michigan - Flint
state: Michigan
Study officials:
affiliation: University of Michigan-Flint
name: Emily Feuerherm, PhD
role: PRINCIPAL_INVESTIGATOR
References: