Improving Health and Environmental Health Literacy of Professionals

NCT05879666 | Completed

• 1 other identifier: IRB22-1510
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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

Conditions

Health Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Reproductive Health Professionals - EHL

EXPERIMENTAL

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

Interventions

Online educational phthalate course BEHAVIORAL

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.

Reproductive Health Professionals - EHL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Practitioner does not interact with patients

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead

Study Sites (1)

Harvard T.H. Chan School of Public Health

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 30, 2023
• Study Start: June 30, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

US (1)