Reducing Pesticide Exposures in Child Care Centers (HCES)
Reducing Pesticide Exposures to Preschool-age Children in California Child Care Centers
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Abbey Alkon, PhD
- Phone Number: 415-476-4695
- Email: abbey.alkon@ucsf.edu
Study Contact Backup
- Name: Evelyn Bigini, MS
- Email: evelyn.bigini@ucsf.edu
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The centers must meet the following criteria:
- Be a licensed child care center with a child care director who speaks English
- Used pesticides (i.e., baits or sprays) in the last year
- Operated for at least two years with no plans to close in the next 12 months
- Enroll children between three to five years of age of diverse ethnic and racial backgrounds
- Have at least 25% of enrolled children receiving a government subsidy (e.g., Child and Adult Care Food Program (CACFP), Head Start, Child Care Development Fund, Alternative Payment program).
- Have a carpet or couch on-site.
The child care providers must meet the following criteria:
- Work in the participating child care centers
- Work in the classroom of the participating children
- Work at least 30 hours a week
- Plan to work at the center over the next 9 months
The families must have a preschool-age child enrolled in the participating child care center and meet the following criteria:
- Three or four years of age
- The child spends at least six hours per day in the center
- Will be enrolled in the center for the next nine months
- Has a parent present during enrollment who speaks either English or Spanish
- Parents will complete surveys or interviews in English or Spanish in the Fall and Spring
Exclusion Criteria:
- Centers that participated in an IPM intervention and training project
- Families that have children who have special health care needs or disabilities who can not participate in physical activity at the child care center.
- Center directors who do not read and write in English.
- Child care providers who do not read and write in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Integrated pest management
The intervention consists of an integrated pest management (IPM) educational workshop, providing IPM materials, and monthly consultation.
The child care health consultants (CCHCs) conduct the educational workshop for child care center directors and providers on IPM practices including the providers' practices and beliefs.
The workshop includes a slide presentation on pesticides and IPM practices and the directors receive an IPM Toolkit and IPM toolbox.
After the workshop and baseline measures are completed, the CCHCs meet with center directors to review the results of the baseline observational Checklists and the directors identify center-specific intervention goals.
Monthly child care health consultation visits are conducted with the director to review the center's progress towards the goals, discuss problems, and share resources.
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In the IPM centers the child care health consultant reviews the IPM baseline assessments and provides 7 monthly consultation visits to decrease the centers exposure to pesticides.
Pre- and post- carpet dust samples and children's individual silicone wristbands are collected to identify changes in pesticide detection limits and concentrations at the child care center-level in both the IPM and PA centers pre- and post-intervention.
Other Names:
In the IPM centers, a research assistant completed the IPM Checklist which identifies the IPM practices that the center meets and doesn't meet.
The child care health consultant reviews the IPM Checklist findings with the child care center director after the baseline Checklist is completed.
The IPM Checklist is completed pre- and post-intervention in the IPM and PA centers.
The post-intervention IPM Checklist findings are compared to the baseline IPM Checklist findings to identify changes in IPM practices in both the IPM and PA centers.
The IPM center directors and providers attend an IPM workshop and complete a survey to assess their knowledge of IPM practices pre- and post-workshop.
The level of knowledge change is assessed by comparing the number of correct responses on the post-workshop survey compared to the pre-workshop survey.
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Active Comparator: Physical activity
The attention control group is given an intervention covering physical activity (PA) for preschool-age children in child care centers.
The PA intervention includes the same intensity as the IPM intervention provided by a child care health consultant (CCHC).
The CCHC conducts a workshop on physical activity that includes a slide presentation and the directors receive a Physical Activity Toolkit and toolbox.
After the workshop and baseline measures are completed, the CCHCs meet with center directors to review the results of the baseline observational Checklists and the directors identify center-specific intervention goals.
Monthly child care health consultation visits are conducted with the director to review the center's progress towards the goals, discuss problems, and share resources.
|
In the IPM centers the child care health consultant reviews the IPM baseline assessments and provides 7 monthly consultation visits to decrease the centers exposure to pesticides.
Pre- and post- carpet dust samples and children's individual silicone wristbands are collected to identify changes in pesticide detection limits and concentrations at the child care center-level in both the IPM and PA centers pre- and post-intervention.
Other Names:
In the IPM centers, a research assistant completed the IPM Checklist which identifies the IPM practices that the center meets and doesn't meet.
The child care health consultant reviews the IPM Checklist findings with the child care center director after the baseline Checklist is completed.
The IPM Checklist is completed pre- and post-intervention in the IPM and PA centers.
The post-intervention IPM Checklist findings are compared to the baseline IPM Checklist findings to identify changes in IPM practices in both the IPM and PA centers.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decrease in Child Care Center Pesticides
Time Frame: Pre-intervention, 9 months after the workshop
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Change in the levels of pesticide exposures collected in carpet dust samples in the child care centers from baseline to 9 months later.
Pesticides are summarized as geometric mean concentration (ng/g) and then the log10 is applied to the data.
Carpet dust samples were collected in each child care center at pre-intervention and post-intervention.
A decrease in pesticide concentration from pre-intervention to post-intervention is represented as a negative value.
A negative change score would be a positive finding with a decrease in pesticide concentration post-intervention.
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Pre-intervention, 9 months after the workshop
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Decrease in Children's Exposure to Pesticides
Time Frame: Pre-intervention and 9 months later (post-intervention)
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Change in the levels of pesticide exposures collected in personal silicone wristbands worn by 3 to 5 of the preschool-age children in each child care center.
They wore the wristbands for ~30 hours pre-intervention/baseline and 9 months later.
Pesticides are summarized as geometric mean concentration (ng/mL) and then log10 is applied to the data.
A decrease in pesticide concentration from pre-intervention to post-intervention is represented as a negative value.
A negative change score would be a positive finding with a decrease in pesticide concentration post-intervention.
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Pre-intervention and 9 months later (post-intervention)
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Increase in Integrated Pest Management (IPM) Practices
Time Frame: Pre-Intervention and 9 months later
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The IPM practices were measured objectively with a standardized IPM Checklist during a 2-hour observational assessment at baseline/pre-intervention and then 9 months later using a standardized measure (Alkon etal, JPHC, 2016).
The IPM practices observed included having garbage cans with liners and lids, using bait stations if there are pests, having window screens with no holes, no water leaks, and outside garbage bins on cement surfaces.
Each item on the Checklist is marked as 1 (yes) or O (no).
The mean ranged from 0 (no practices observed) to 1 (all of the items were observed).
An increase in IPM practices would be positive change in the mean score post-intervention compared to pre-intervention.
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Pre-Intervention and 9 months later
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decrease in the Presence of Pests
Time Frame: Pre-intervention and 9 months later
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The # of pests were observed as part of the IPM Checklist assessment in different places in the child care center: kitchen, outside garbage area, playground, landscape outdoor area, and classroom at the pre-intervention period and 9 months later.
Pre- and post-intervention, the # of pests observed is a number on a scale of 0 to infinity.
A positive outcome would be a negative change score showing be a decrease in the # of pests observed post-intervention compared to pre-intervention.
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Pre-intervention and 9 months later
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Director's Self-Efficacy
Time Frame: The Self-Efficacy Survey is completed by the directors pre-intervention and after the intervention (7 to 9 months later).
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The director's sense of self-efficacy provides information about their sense of control of their work environment and impact on the families and children that they serve.
The intervention is designed to help the director's feel empowered (e.g., increase in self-efficacy) to make changes in their work environment and provide a healthy environment for children and families served in their center.
The Self-Efficacy survey was modified from a standardized measure by Bandura, A (1977) to fit the intervention and child care center's environments.
There are 8 items with responses rated on a likert scale from 1 to 4 as strongly disagree (1) to strongly agree (4).
Mean self-efficacy scores were calculated for each director.
The minimum and maximum mean scores were 2.8 to 4.0.
Higher mean score shows higher self-efficacy.
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The Self-Efficacy Survey is completed by the directors pre-intervention and after the intervention (7 to 9 months later).
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Number of Child Care Centers With Written IPM Policies
Time Frame: 9 months
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The presence of IPM policies was reviewed as (1 for "Yes") and (0 for "No") no both pre- and post-intervention in the IPM centers.
Licensed child care centers are required to have written policies, but a specific policy on IPM is not required.
Policies provide best practices for the child care administrators, providers and parents to follow when working or spending time in the center.
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9 months
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knowledge
Time Frame: pre- and immediately after the workshop is completed
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An 8-item multiple choice knowledge survey was completed by participants who attended the IPM workshop pre- and post-workshop.
The survey was developed by the PI and contained key content covered in the IPM workshop.
There were 70 child care providers who attended the workshops and completed the knowledge and demographic surveys.
Correct answers were coded as 'correct' and given a score of '1'.
The range of scores for each participant were from 0 to 8 (all correct answers).
The scores for each participant were calculated and then aggregated by center.
Positive changes in scores showed an increase in IPM knowledge post-workshop compared to baseline.
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pre- and immediately after the workshop is completed
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Thaddeus Schug, PhD, National Institute for Environmental Health Sciences
Publications and helpful links
General Publications
- Alkon A, Nouredini S, Swartz A, Sutherland AM, Stephens M, Davidson NA, Rose R. Integrated Pest Management Intervention in Child Care Centers Improves Knowledge, Pest Control, and Practices. J Pediatr Health Care. 2016 Nov-Dec;30(6):e27-e41. doi: 10.1016/j.pedhc.2016.07.004. Epub 2016 Aug 20.
- Bradman, A, Gasper, F, Castorina, R, Tong-Lin, E, McKone, T, & Maddelena, R. (2012). Environmental exposures in early childhood education environments (Agreement Number 08-305). Retrieved from Berkeley, CA:
- Vidi PA, Anderson KA, Chen H, Anderson R, Salvador-Moreno N, Mora DC, Poutasse C, Laurienti PJ, Daniel SS, Arcury TA. Personal samplers of bioavailable pesticides integrated with a hair follicle assay of DNA damage to assess environmental exposures and their associated risks in children. Mutat Res Genet Toxicol Environ Mutagen. 2017 Oct;822:27-33. doi: 10.1016/j.mrgentox.2017.07.003. Epub 2017 Jul 16.
- Alkon A, Gunier RB, Hazard K, Castorina R, Hoffman PD, Scott RP, Anderson KA, Bradman A. Preschool-Age Children's Pesticide Exposures in Child Care Centers and at Home in Northern California. J Pediatr Health Care. 2022 Jan-Feb;36(1):34-45. doi: 10.1016/j.pedhc.2021.09.004. Epub 2021 Oct 8.
- Hazard K, Alkon A, Gunier RB, Castorina R, Camann D, Quarderer S, Bradman A. Predictors of pesticide levels in carpet dust collected from child care centers in Northern California, USA. J Expo Sci Environ Epidemiol. 2024 Mar;34(2):229-240. doi: 10.1038/s41370-022-00516-8.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 4000 317004 130129A 01 44
- R01ES027134 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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