Health Knowledge, Attitudes, Practice Clinical Trial
— IHEHLPOfficial title:
Improving Health and Environmental Health Literacy of Professionals
| 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 |
| Verified date | April 2024 |
| Source | Harvard School of Public Health (HSPH) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Harvard T.H. Chan School of Public Health | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Harvard School of Public Health (HSPH) |
United States,
| 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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