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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03319927
Other study ID # 4000 317004 130129A 01 44
Secondary ID 1R01ES027134-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date October 9, 2017
Est. completion date August 31, 2024

Study information

Verified date July 2023
Source University of California, San Francisco
Contact Abbey Alkon, PhD
Phone 415-476-4695
Email abbey.alkon@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 440
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
IPM educational workshop and consultation
The interventions include a baseline assessment conducted by a research assistant and objective measures of pesticide exposure (center dust samples, children's silicone wristbands), review of assessment by the nurse child care health consultant, goal setting with the director, educational workshop, 7 monthly consultation visits, and post-intervention review of goals and post-assessment findings (conducted by research assistant and objective measures of pesticide exposure).

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (4)

Lead Sponsor Collaborator
University of California, San Francisco National Institute of Environmental Health Sciences (NIEHS), Oregon State University, University of California, Berkeley

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 — View 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. — View 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:

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. 2023 Jan 4:1-12. doi: 10.1038/s41370-02 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in knowledge Change in responses to a multiple choice survey on content covered in the workshops from pre- to post-workshop pre- and immediately after the workshop is completed
Other Change in child body mass index (BMI) Collect children's height in cm and weight in meters and calculate BMI (kg/(meter squared)) Before the educational workshop and 9 months after the workshop
Primary Change in child care center pesticide exposures Change in the levels of pesticide exposures collected in dust samples in the child care centers from baseline to 9 months later. Pesticides will be summarized as mean concentration (ng/g) and loading (ng/m2). Before the educational workshop and 9 months after the workshop
Primary Change in personal pesticide exposures Change in the levels of pesticide exposures collected in personal silicone wristbands from baseline to 9 months later. Pesticides will be summarized as mean concentration (ng/mL). Before the educational workshop and 9 months after the workshop
Secondary Change in integrated pest management (IPM) practices a. Change in the IPM policies and practices identified during a 2-hour observational assessment using a standardized Policies Checklist and IPM Checklist to assess level of IPM practices from baseline to 9 months later.. Before the educational workshop and 9 months after the workshop
Secondary Change in the presence of pests or evidence of pests Change in the observed # of pests or evidence of pests as part of the IPM Checklist assessment from baseline to 9 months later. Before the educational workshop and 9 months after the workshop
Secondary Change in integrated pest management (IPM) policies a. Change in the IPM policies identified during an assessment using a standardized Policies Checklist to assess presence of written IPM policy and if present, the quality of the IPM policy. Before the educational workshop and 9 months after the workshop
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