Clinical trial NCT03319927: Reducing Pesticide Exposures in Child Care Centers
Official title: Reducing Pesticide Exposures to Preschool-age Children in California Child Care Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children, Only
Risk Reduction
Environmental Exposure
Keywords: integrated pest management
environmental health
child care
preschool children
pesticides
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
name: University of California, Berkeley
name: Oregon State University
First posted: 2017-10-24
Enrollment: 440
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized control study will include 88 child care centers in four CA counties and be conducted in 9-month cycles over five years. The counties will be matched and randomized to the intervention group (integrated pest management) or attention control group (physical activity). Each study cycle will include Recruitment, Baseline Assessments, Intervention, and Post-Intervention Assessments. Baseline Assessments are completed as director interviews, child care provider surveys, research assistant objective observations using standardized Checklists, review of written policies, child anthropometrics, center dust samples to measure pesticides, and silicone wristband personal samplers worn by 5 children per center for a 7-days. During the 7-month Intervention phase, CCHCs will conduct one workshop per center on the intervention topic (IPM or physical activity) and provide seven monthly consultations per center. The Post-Intervention stage will repeat all the baseline assessments.
Primary purpose: PREVENTION

Brief summary: To reduce the risk of adverse health problems associated with chronic exposure to pesticides, a randomized control study will evaluate a nurse-led integrated pest management (IPM) intervention in 88 child care centers serving socio-economically and ethnically diverse preschool-age children in four California counties. Positive changes in IPM knowledge, policies, practices, pests, and pesticide exposure will be assessed.

Detailed description: The goal of this study is to reduce children's exposure to pesticides in child care centers to improve their long-term health. A randomized-control trial in four northern California counties will compare changes in pesticide exposure among child care centers assigned to an IPM intervention versus an attention control intervention on physical activity. Eighty-eight child care centers serving socio-economically and ethnically diverse preschool-age children will be enrolled. This study will be modeled on a successful nurse-led child care health consultation intervention comprised of an educational workshop, materials and tools, and center-specific consultation over seven months. In addition, the study will include novel methods of measuring pesticide concentrations in child care centers (dust) and to individual children in the child care settings (silicone wristbands). The study aims are to determine if a nurse-led IPM intervention (1) increases child care center staff's IPM knowledge, (2) improves center's IPM policies and practices, (3) reduces pest problems (i.e., pests present, pest residue), (4) increases director's self-efficacy, (5) reduces pesticide exposures in child care center environments, and (6) reduces child-level pesticide exposures in the intervention child care centers compared to the control centers.

Eligibility criteria: Inclusion Criteria:

The centers must meet the following criteria:

1. Be a licensed child care center with a child care director who speaks English
2. Used pesticides (i.e., baits or sprays) in the last year
3. Operated for at least two years with no plans to close in the next 12 months
4. Enroll children between three to five years of age of diverse ethnic and racial backgrounds
5. 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).
6. Have a carpet or couch on-site.

The child care providers must meet the following criteria:

1. Work in the participating child care centers
2. Work in the classroom of the participating children
3. Work at least 30 hours a week
4. 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:

1. Three or four years of age
2. The child spends at least six hours per day in the center
3. Will be enrolled in the center for the next nine months
4. Has a parent present during enrollment who speaks either English or Spanish
5. Parents will complete surveys or interviews in English or Spanish in the Fall and Spring

Exclusion Criteria:

1. Centers that participated in an IPM intervention and training project
2. Families that have children who have special health care needs or disabilities who can not participate in physical activity at the child care center.
3. Center directors who do not read and write in English.
4. Child care providers who do not read and write in English.

Primary outcomes:
measure: Change in child care center pesticide exposures
timeFrame: Before the educational workshop and 9 months after the workshop
measure: Change in personal pesticide exposures
timeFrame: Before the educational workshop and 9 months after the workshop
Secondary outcomes:
measure: Change in integrated pest management (IPM) practices
timeFrame: Before the educational workshop and 9 months after the workshop
measure: Change in the presence of pests or evidence of pests
timeFrame: Before the educational workshop and 9 months after the workshop
measure: Change in integrated pest management (IPM) policies
timeFrame: Before the educational workshop and 9 months after the workshop
Other outcomes:
measure: Change in knowledge
timeFrame: pre- and immediately after the workshop is completed
measure: Change in child body mass index (BMI)
timeFrame: Before the educational workshop and 9 months after the workshop
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: National Institute for Environmental Health Sciences
name: Lindsey A Martin, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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:
citation: 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.
citation: 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.
citation: 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.