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Clinical Trials/NCT05879666
NCT05879666
Completed
N/A

Improving Health and Environmental Health Literacy of Professionals

Harvard School of Public Health (HSPH)1 site in 1 country213 target enrollmentJune 30, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Knowledge, Attitudes, Practice
Sponsor
Harvard School of Public Health (HSPH)
Enrollment
213
Locations
1
Primary Endpoint
Change from baseline phthalate environmental health literacy
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to understand the impact of an educational intervention on reproductive health care providers' environmental health literacy related to phthalates. The main questions to answer are:

  1. Does a web-based educational intervention improve the environmental health literacy of personal care product chemicals based on pre/post/post intervention survey data?
  2. Does a web-based educational intervention improve reproductive health professionals' confidence and awareness for communication to patients on environmental health literacy?
  3. Do concentrations of personal care product chemicals in reproductive health professionals decrease after the web-based educational intervention?

Participants will be asked to complete three surveys: one before the educational intervention, and two after the intervention. The will be asked to complete the approximately 1-hour online educational intervention, which consists of a series of videos from the perspectives of patients, OBGYNs, and researchers, an interactive module, and a worksheet to facilitate conversation with patients.

Registry
clinicaltrials.gov
Start Date
June 30, 2023
End Date
March 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Harvard School of Public Health (HSPH)
Responsible Party
Principal Investigator
Principal Investigator

Tamarra James-Todd

Primary Investigator

Harvard School of Public Health (HSPH)

Eligibility Criteria

Inclusion Criteria

  • Employed in a patient-facing role relevant to reproductive health care (e.g., obstetricians, gynecologists, medical assistants, doulas, and nurses, etc.)

Exclusion Criteria

  • Practitioner does not interact with patients

Outcomes

Primary Outcomes

Change from baseline phthalate environmental health literacy

Time Frame: Up to 4 weeks

Measure of phthalate reproductive environmental health literacy via validated scale (post educational intervention), the Phthalate Environmental Reproductive Health Literacy (PERHL) scale. Scores on the PERHL scale range from 6-31, with a higher score indicating higher environmental health literacy.

Sustained change from baseline phthalate environmental health literacy

Time Frame: 2 months

Measure of phthalate reproductive environmental health literacy via validated scale (2 months post educational intervention), the Phthalate Environmental Reproductive Health Literacy (PERHL) scale. Scores on the PERHL scale range from 6-31, with a higher score indicating higher environmental health literacy.

Baseline urinary biomarkers of phthalate exposure

Time Frame: Up to 2 weeks

Collected via urine samples, measure of previous phthalate exposures. We will evaluate urine samples for urinary phthalate metabolite concentrations using a standard panel, measuring 16 urinary phthalate metabolites and their replacements (CX-MINCH, MECPTP, MEHHTP, OH-MINCH, mBP, mBzP, mCnP, mCOP, mCPP, mECPP, mEHHP, mEHP, mEOHP, mEP, mNP, miBP), and assayed using a modified method from the Centers for Disease Control and Prevention. Briefly, HPLC-MS/MS ESI is conducted based on the CDC's Phthalate Metabolites in Urine Method No: 6306.03. We will also calculate the molar sums of SG-adjusted metabolites representing metabolites related to parent compound DEHP (i.e., ΣDEHP = (mEHP/278) + (mEHHP/294) + (mEOHP/292) + (mECPP/308)) and personal care product (PCP)-associated phthalates (i.e., ΣPCP = (mBP/222) + (miBP/222) + (mEP/194)). Units for all metabolites will be ng/mL.

Baseline phthalate environmental health literacy

Time Frame: Up to 2 weeks

Measure of phthalate reproductive environmental health literacy via validated scale (pre educational intervention), the Phthalate Environmental Reproductive Health Literacy (PERHL) scale. Scores on the PERHL scale range from 6-31, with a higher score indicating higher environmental health literacy.

Change in urinary biomarkers of phthalate exposure

Time Frame: Up to 4 weeks

Collected via urine samples, measure of previous phthalate exposures. We will evaluate urine samples for urinary phthalate metabolite concentrations using a standard panel, measuring 16 urinary phthalate metabolites and their replacements (CX-MINCH, MECPTP, MEHHTP, OH-MINCH, mBP, mBzP, mCnP, mCOP, mCPP, mECPP, mEHHP, mEHP, mEOHP, mEP, mNP, miBP), and assayed using a modified method from the Centers for Disease Control and Prevention. Briefly, HPLC-MS/MS ESI is conducted based on the CDC's Phthalate Metabolites in Urine Method No: 6306.03. We will also calculate the molar sums of SG-adjusted metabolites representing metabolites related to parent compound DEHP (i.e., ΣDEHP = (mEHP/278) + (mEHHP/294) + (mEOHP/292) + (mECPP/308)) and personal care product (PCP)-associated phthalates (i.e., ΣPCP = (mBP/222) + (miBP/222) + (mEP/194)). Units for all metabolites will be ng/mL.

Study Sites (1)

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