Doulas as Environmental Educators and Partners Study
DEEP
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
September 11, 2023
CompletedStudy Start
First participant enrolled
October 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2026
CompletedDecember 26, 2025
December 1, 2025
2.3 years
July 26, 2023
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
Baseline urinary biomarkers of phthalate exposure
Collected via urine samples, measure of previous phthalate exposures for urinary phthalate metabolite concentrations using a standard panel, measuring 16 urinary phthalate metabolites and their replacements (Cyclohexane-1,2-dicarboxylic acid mono carboxyisooctyl ester (CX-MINCH), mono-2-ethyl-5- carboxypentyl terephthalate (MECPTP), mono-2-ethyl-5-hydroxyhexyl terephthalate (MEHHTP), Cyclohexane-1,2-dicarboxylic acid mono hydroxyisononyl ester (OH-MINCH), mono-n-butylphthalate (mBP), mono-benzyl phthalate (mBzP), mono-carboxy isononyl phthalate (mCnP), mono-carboxy octyl phthalate (mCOP), mono (3-carboxypropyl) phthalate(mCPP), mono-(2-ethyl-5-carboxypentyl) phthalate (mECPP), mono (2-ethyl-5-hydroxyhexyl) phthalate (mEHHP), mono ethyl hexyl phthalate (mEHP), mono (2-ethyl-5-oxohexyl) phthalate (mEOHP), monoethyl phthalate (mEP), mono-isononyl phthalate (mNP), mono-isobutyl phthalate (miBP), and assayed using a modified method from the Centers for Disease Control and Prevention.
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 (4)
Intervention Doulas
EXPERIMENTALDoulas randomized to the intervention group will engage in a one-hour online course about exposure to phthalates and the relationship with reproductive health.
Control Doulas
SHAM COMPARATORDoulas randomized to the control group will access a worksheet about an alternative environmental exposure and the relationship with reproductive health.
Intervention Pregnant Individuals
EXPERIMENTALPregnant individuals working with intervention doulas will be asked to have a conversation with their doulas about environmental chemicals (phthalates).
Control Pregnant Individuals
SHAM COMPARATORPregnant individuals working with control doulas will be asked to have a conversation with their doulas about environmental chemicals (distinct from phthalates).
Interventions
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.
Participants in the control group will receive access to environmental exposures other than phthalates.
Participants in the intervention groups will be asked to engage in conversations about phthalates between doulas/pregnant individuals.
Participants in the intervention groups will be asked to engage in conversations about environmental exposures (other than phthalates) between doulas/pregnant individuals.
Eligibility Criteria
You may qualify if:
- Doulas currently working with pregnant individuals \<30 weeks into their pregnancy
- Pregnant individuals working with doulas who are \<30 weeks into their pregnancy
You may not qualify if:
- Doulas not currently working with pregnant individuals \<30 weeks into their pregnancy
- Pregnant individuals working with doulas who are beyond 30 weeks into their pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
July 26, 2023
First Posted
September 11, 2023
Study Start
October 20, 2023
Primary Completion
January 30, 2026
Study Completion
February 15, 2026
Last Updated
December 26, 2025
Record last verified: 2025-12