Doulas as Environmental Educators and Partners Study

NCT06032143 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-26

No results posted yet for this study

Summary

The aims of this project are:

Aim 1: Determine the extent to which an environmental health literacy educational intervention designed for doulas improves their environmental health literacy of endocrine disrupting chemicals (EDCs) in personal care products.

Hypothesis 1a. Doulas who participate in an environmental health literacy course will have a higher environmental health literacy score based on quantitative questionnaire evaluation post-course compared to pre-course.

Hypothesis 1b. Doulas who participate in the environmental health literacy course will have a higher environmental health literacy scores post-course compared to doulas who do not take the environmental health literacy course.

Aim 2: Determine the extent to which pregnant people counseled by doulas with training in environmental health literacy have higher environmental health literacy scores and lower usage of personal care products containing EDCs following doula counseling.

Hypothesis 2a. Compared to pregnant people not counseled by doulas on EDCs in personal care products, pregnant individuals counseled by doulas on these EDCs will have improved scores in environmental health literacy.

Hypothesis 2b. Compared to pregnant people not counseled by doulas on EDCs in personal care products, pregnant individuals receiving counseling will use fewer personal care products associated with containing EDCs based on a validated questionnaire.

Aim 3: Determine whether concentrations of EDC biomarkers decreased after the intervention for the intervention group.

Hypothesis 3: Urinary phthalate metabolite concentrations will be lower post-course compared to pre-course for the intervention group.

Conditions

  • Health Knowledge, Attitudes, Practice

Interventions

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.

BEHAVIORAL

Control environmental education

Participants in the control group will receive access to environmental exposures other than phthalates.

BEHAVIORAL

Phthalate conversation

Participants in the intervention groups will be asked to engage in conversations about phthalates between doulas/pregnant individuals.

BEHAVIORAL

Environmental exposures conversation

Participants in the intervention groups will be asked to engage in conversations about environmental exposures (other than phthalates) between doulas/pregnant individuals.

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2026-01-30
Completion
2026-02-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06032143 on ClinicalTrials.gov