Pesticide SafetyNCT04298632
Latino Youth Agricultural Study
A study testing Safety Education Program in people with Pesticide Safety, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The goal of the project is to determine the effectiveness of each intervention in promoting increased knowledge and practice of pesticide safety behaviors. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Pesticide Safety
- What is being tested?
- Safety Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent self-identifies as Latino, Hispanic, or of Latin American heritage
- Adolescent is between the ages of 12-21
- Adolescent has been engaged (paid or unpaid) in farm work for at least 10 hours in he last 30 days
- Adolescent has a parent living with them
Who cannot join
- Refusal of youth to provide assent or parent to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Pesticide Exposure Among Latino Adolescents Through a Promotora-based Intervention
This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The goal of the project is to determine the effectiveness of each intervention in promoting increased knowledge and practice of pesticide safety behaviors.
Read the detailed description
This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The intervention will be delivered to two different treatment groups: 1) adolescent only, adolescents receive the adapted adolescent version of La Familia Sana program and 2) family enhanced, adolescent and mother both receive the La Familia Sana program. In addition, there will be a control group where adolescent farmworkers will not be exposed to any pesticide safety program. Our project will:
- Determine if a promotora-based intervention targeting pesticide safety in the workplace is effective in increasing knowledge about safety behaviors among Latino adolescents engaged in farm work.
- Delineate variation by group among adolescents' knowledge about safety behaviors.
- Delineate variation in adolescents' pesticide safety behaviors and neurological outcomes after intervention between all groups.
- Conditions
- Pesticide Safety
- Being tested
- Safety Education Program
- Keywords
- Latino Youth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Education ProgramBehavioural
this is a pesticide safety education program
| Study group | Role | What they receive |
|---|---|---|
| Youth-only | Experimental | Only the youth receives the education program Receives: Behavioral: Safety Education Program |
| Family enhanced | Experimental | A parent and the youth both receive the education program Receives: Behavioral: Safety Education Program |
| Control | No intervention | neither parent, nor youth receives the education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge of pesticide safety behaviors
This outcome measure will be assessed by a series of nine questions asking adolescents "How do you believe that farmworkers can come in contact with pesticides while working?" Additionally, nine additional questions will be asked that assess "How do you believe that farmworkers can have contact with pesticides while at home?" All responses for these questions are "yes" or "no"
Measured: 7 weeks
Self-protective behaviors
Self-protective behaviors will be assessed by items asking adolescents about their clothes wearing and handling and their hand washing behaviors. Items regarding clothes wearing and handling include self-reported frequency of removing shoes and clothes prior to entering their home and wearing the same clothes more than one day. Additionally, several questions ask about the frequency of wearing shorts, sandals, gloves, etc. Regarding hand washing behavior, adolescents will self-report their hand washing behaviors at pretest and posttest. These questions ask youth about the frequency in which they wash their hands prior to eating, drinking, chewing gum, using the restroom, touching co-workers, etc. All self-protective behavior questions have a response option of "never", "sometimes", "usually", and "always"
Measured: 7 weeks
Secondary outcomes (1)
Neurological functioning
Neurological functioning in the form of coordination and fine motor skills will be assessed by the finger tapper test. This measure focuses specifically on speed and is sensitive to the effects of neurotoxicants. The finger tapper test produces a mean score for both the participant's dominant and non-dominant hand as a result of a series of 10 second tapping exercises.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start30 Sep 2019
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pesticide SafetyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298632
- Sponsor's protocol ID
- 20734
- Other IDs
- 2U54OH007541-16
- Status last verified
- Dec 2022
- First submitted
- 3 Mar 2020
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data collected from this project will be made available to other researchers within 2 years of completing the project. Those wishing to use the data will be required to submit an application indicating the purpose for which the data will be used and documenting that the research protocol has been approved by the appropriate IRB. Any costs involved in the providing access to data (e.g., statistical and programming support, duplication of documentation) will be paid by those requesting access.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Pesticide Exposure Among Latino Adolescents Through a Promotora-based Intervention
- ClinicalTrials.gov ID
- NCT04298632
- Acronym / sponsor ID
- 20734
- Conditions
- Pesticide Safety
- Keywords
- Latino Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The goal of the project is to determine the effectiveness of each intervention in promoting increased knowledge and practice of pesticide safety behaviors.
Detailed description
This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The intervention will be delivered to two different treatment groups: 1) adolescent only, adolescents receive the adapted adolescent version of La Familia Sana program and 2) family enhanced, adolescent and mother both receive the La Familia Sana program. In addition, there will be a control group where adolescent farmworkers will not be exposed to any pesticide safety program. Our project will:
- Determine if a promotora-based intervention targeting pesticide safety in the workplace is effective in increasing knowledge about safety behaviors among Latino adolescents engaged in farm work.
- Delineate variation by group among adolescents' knowledge about safety behaviors.
- Delineate variation in adolescents' pesticide safety behaviors and neurological outcomes after intervention between all groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Youth-only | Experimental | Behavioral: Safety Education ProgramOnly the youth receives the education program |
| Family enhanced | Experimental | Behavioral: Safety Education ProgramA parent and the youth both receive the education program |
| Control | No intervention | –neither parent, nor youth receives the education program |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent self-identifies as Latino, Hispanic, or of Latin American heritage
- Adolescent is between the ages of 12-21
- Adolescent has been engaged (paid or unpaid) in farm work for at least 10 hours in he last 30 days
- Adolescent has a parent living with them
Key exclusion criteria (1 listed)
- Refusal of youth to provide assent or parent to provide consent
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 |
|---|---|---|
| Safety Education Programthis is a pesticide safety education program | Behavioural | Family enhanced, Youth-only |
Primary outcome
knowledge of pesticide safety behaviors
Time frame: 7 weeks
This outcome measure will be assessed by a series of nine questions asking adolescents "How do you believe that farmworkers can come in contact with pesticides while working?" Additionally, nine additional questions will be asked that assess "How do you believe that farmworkers can have contact with pesticides while at home?" All responses for these questions are "yes" or "no"
Self-protective behaviors
Time frame: 7 weeks
Self-protective behaviors will be assessed by items asking adolescents about their clothes wearing and handling and their hand washing behaviors. Items regarding clothes wearing and handling include self-reported frequency of removing shoes and clothes prior to entering their home and wearing the same clothes more than one day. Additionally, several questions ask about the frequency of wearing shorts, sandals, gloves, etc. Regarding hand washing behavior, adolescents will self-report their hand washing behaviors at pretest and posttest. These questions ask youth about the frequency in which they wash their hands prior to eating, drinking, chewing gum, using the restroom, touching co-workers, etc. All self-protective behavior questions have a response option of "never", "sometimes", "usually", and "always"
1 secondary outcome
Neurological functioning
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: Yes. The data collected from this project will be made available to other researchers within 2 years of completing the project. Those wishing to use the data will be required to submit an application indicating the purpose for which the data will be used and documenting that the research protocol has been approved by the appropriate IRB. Any costs involved in the providing access to data (e.g., statistical and programming support, duplication of documentation) will be paid by those requesting access.
Related trials for Pesticide Safety
Not yet recruiting
COM-B Model-based Behavioral Intervention on Safe Pesticide Use and Food Safety Practice Among Farmers
Pesticide Exposure, Food Safety
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Education Program in people with Pesticide Safety, run by University of Nebraska Lincoln 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 4 inclusion and 1 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 19 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
knowledge of pesticide safety behaviors (time frame: 7 weeks). 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?
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 19 Dec 2022.