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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05879666
Other study ID # IRB22-1510
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2023
Est. completion date March 30, 2024

Study information

Verified date April 2024
Source Harvard School of Public Health (HSPH)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 213
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Health Knowledge, Attitudes, Practice

Intervention

Behavioral:
Online educational phthalate course
This is an online course focused on phthalates for reproductive health professionals. It consists of videos from patient, scientist, and OBGYN perspectives describing how phthalates relate to reproductive health. There is also an interactive module and worksheet to facilitate conversations about phthalates with pregnant individuals.

Locations

Country Name City State
United States Harvard T.H. Chan School of Public Health Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Harvard School of Public Health (HSPH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline phthalate environmental health literacy 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. Up to 2 weeks
Primary Change from baseline phthalate environmental health literacy 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. Up to 4 weeks
Primary Sustained change from baseline phthalate environmental health literacy 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. 2 months
Primary Baseline urinary biomarkers of phthalate exposure 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., SDEHP = (mEHP/278) + (mEHHP/294) + (mEOHP/292) + (mECPP/308)) and personal care product (PCP)-associated phthalates (i.e., SPCP = (mBP/222) + (miBP/222) + (mEP/194)). Units for all metabolites will be ng/mL. Up to 2 weeks
Primary Change in urinary biomarkers of phthalate exposure 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., SDEHP = (mEHP/278) + (mEHHP/294) + (mEOHP/292) + (mECPP/308)) and personal care product (PCP)-associated phthalates (i.e., SPCP = (mBP/222) + (miBP/222) + (mEP/194)). Units for all metabolites will be ng/mL. Up to 4 weeks
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