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Reducing Pesticide Exposure to Preschool-age Children

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ClinicalTrials.gov Identifier: NCT03319927
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
National Institute of Environmental Health Sciences (NIEHS)
University of California, Berkeley
Oregon State University
Information provided by (Responsible Party):
Abbey Alkon, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Children, Only Risk Reduction Environmental Exposure Behavioral: IPM educational workshop and consultation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Pesticide Exposures to Preschool-age Children in California Child Care Centers
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Integrated pest management
The intervention consists of an integrated pest management (IPM) educational workshop and consultation. The child care health consultants (CCHCs) conduct the educational workshop for child care center directors and providers on IPM policies and practices including the providers' practices and beliefs. The workshop includes IPM videos, IPM Toolkit, and IPM toolbox. The (CCHCs) meet with center directors to review the results of the Baseline observational Checklists and to identify center-specific intervention goals. The intervention also includes 7 monthly child care health consultation visits where the CCHC and director review the center's progress towards the intervention goals, discuss problems, and share resources.
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).
Other Name: Physical activity educational workshop and consultation

Active Comparator: Physical activity
The intervention consists of a physical activity educational workshop and consultation. The child care health consultants (CCHCs) conduct the educational workshop for the child care center directors and providers on physical activities center policies and best practices over 7 months. The workshop includes a Physical Activity Toolkit and toolbox. The (CCHCs) meet with center directors to review the results of the Baseline observational Checklists and to identify center-specific intervention goals. The intervention also includes 7 monthly child care health consultation visits where the CCHC and director review the center's progress towards the intervention goals, discuss problems, and share resources.
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).
Other Name: Physical activity educational workshop and consultation




Primary Outcome Measures :
  1. Change in child care center pesticide exposures [ Time Frame: Before the educational workshop and 9 months after the workshop ]
    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).

  2. Change in personal pesticide exposures [ Time Frame: Before the educational workshop and 9 months after the workshop ]
    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).


Secondary Outcome Measures :
  1. Change in integrated pest management (IPM) practices [ Time Frame: Before the educational workshop and 9 months after the workshop ]
    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..

  2. Change in the presence of pests or evidence of pests [ Time Frame: Before the educational workshop and 9 months after the workshop ]
    Change in the observed # of pests or evidence of pests as part of the IPM Checklist assessment from baseline to 9 months later.

  3. Change in integrated pest management (IPM) policies [ Time Frame: Before the educational workshop and 9 months after the workshop ]
    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.


Other Outcome Measures:
  1. Change in knowledge [ Time Frame: pre- and immediately after the workshop is completed ]
    Change in responses to a multiple choice survey on content covered in the workshops from pre- to post-workshop

  2. Change in child body mass index (BMI) [ Time Frame: Before the educational workshop and 9 months after the workshop ]
    Collect children's height in cm and weight in meters and calculate BMI (kg/(meter squared))



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 of 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319927


Contacts
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Contact: Abbey Alkon, PhD 415-476-4695 abbey.alkon@ucsf.edu
Contact: Kimberly Hazard, BS 415-502-2825 kimberly.hazard@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Abbey Alkon, PhD    415-476-4695    abbey.alkon@ucsf.edu   
Contact: Kimberly Hazard, BS    415-502-2825    kimberly.hazard@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Institute of Environmental Health Sciences (NIEHS)
University of California, Berkeley
Oregon State University
Investigators
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Study Chair: Kimberly Gray, PhD National Institute for Environmental Health Sciences

Publications of Results:
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Responsible Party: Abbey Alkon, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03319927     History of Changes
Other Study ID Numbers: 4000 317004 130129A 01 44
1R01ES027134-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abbey Alkon, University of California, San Francisco:
integrated pest management
environmental health
child care
preschool children
pesticides