Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04125680
Other study ID # HUM #00148555
Secondary ID UL1TR002240
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04475003 - Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Completed NCT03061123 - Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular AF
Completed NCT02522624 - Supporting Decisions About Health Insurance to Improve Care for the Uninsured N/A
Completed NCT03203018 - Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities N/A
Completed NCT05974865 - Amelioration of Literacy Deficits in Prenatal Care N/A
Completed NCT03584490 - Reducing Assessment Barriers for Patients With Low Literacy N/A
Not yet recruiting NCT05791084 - Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy N/A
Recruiting NCT05024227 - The Effect of Nursing Education Intervention on Women's Health Literacy of Plasticizers N/A
Completed NCT01460953 - Use of a Training Video to Teach Medical Students About Health Literacy N/A
Completed NCT05176236 - Pictographic Education Handout on Tracheostomy Care N/A
Completed NCT05618665 - The Effect of Asthma Education Given by Taking Health Literacy Into Account N/A
Completed NCT02615769 - Effect on Attendance if Including Focused Information of Spirometry in Preventive Health Checks N/A
Completed NCT01474733 - Effects of a Longitudinal Health Literacy Training Program on Family Medicine Residents N/A
Completed NCT00558233 - Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid N/A
Active, not recruiting NCT04252677 - Health Literacy and Obesogenic Behaviors N/A
Recruiting NCT05659693 - The Effect of Digital Literacy Education Given to Postmenopausal Women on Health Literacy and Quality of Life N/A
Not yet recruiting NCT05558631 - Longitudinal Study of Health Literacy in the Municipality of Leiria
Recruiting NCT03105713 - Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery N/A
Completed NCT01351441 - Minimizing Risk and Maximizing Outcomes in Geriatric Patients Through Integrated Clinical Pharmacy Services in an Innovative Model of Community Practice N/A