Improving Health and Environmental Health Literacy of Professionals (IHEHLP)

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.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Behavioral: Online educational phthalate course

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard T.H. Chan School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reproductive Health Professionals - EHL; All participants will complete a pre-course survey, engage in the online educational intervention, then complete 2 post-course surveys. They have the option to provide urine samples before and after the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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., 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.	Up to 2 weeks
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., 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.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB22-1510

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No