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Active, Not Recruiting

NCT Number: NCT06032143

Doulas as Environmental Educators and Partners Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard T.H. Chan School of Public Health

Boston, Massachusetts, 02115, United States

About this study

Compared to other racial/ethnic groups, non-Hispanic black women have significantly higher concentrations of endocrine disrupting chemicals (EDCs) found in personal care products, including phthalates and parabens These EDCs are linked to a variety of adverse reproductive health outcomes that range from early puberty to preterm birth to hot flashes-all conditions that disproportionately impact black women and their long-term health.

Pregnancy is a particularly sensitive window of exposure to EDCs due to normal physiologic changes that alter the body's lipid and glucose metabolism, vasculature, inflammatory, and coagulation responses. Sadly, pregnancy holds some of the most shocking racial/ethnic health disparities, including a 50% increased risk of preterm birth, up to 2-fold increased risk of preeclampsia, and 3-fold increased risk of maternal mortality. Gaps in health care access have been documented as important contributors to these adverse health outcomes, but little research has evaluated the critical gap in environmental health information, particularly information linked to knowledge, awareness, and action related to EDC exposures. In black pregnant people, doulas have increasingly served an important role in filling health care gaps by providing access, advocacy, support, and education at this sensitive window. Yet, doulas often are not equipped to provide key environmental health information around chemical exposures that are higher in black women. If doulas' environmental health literacy of personal care product EDCs linked to adverse pregnancy outcomes was improved, then pregnant people in their care could benefit from reduced exposure to these chemicals and improved pregnancy outcomes. With this, the investigators intend to leverage the supportive advocacy and educational role doulas provide to black pregnant people to improve EDC environmental health literacy by partnering with Black Millennials 4 Flint organization to 1) educate doulas on EDCs; 2) utilize this newly gained knowledge in a clinical setting for doulas to counsel pregnant people on personal care product EDC chemicals; 3) measure environmental health literacy in doulas and the pregnant people they counsel; 4) evaluate urinary phthalate metabolite concentrations before and after the intervention. To conduct this intervention, the investigators will leverage a personal care product EDC module developed by the Harvard Chan's Environmental Reproductive Justice Lab (PI: Dr. Tamarra James-Todd). The investigators will also utilize an environmental health literacy questionnaire, as well as other previously validated quantitative and qualitative data collection tools. 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Doulas currently working with pregnant individuals <30 weeks into their pregnancy
  • Pregnant individuals working with doulas who are <30 weeks into their pregnancy

Exclusion criteria

  • 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

Treatment and study plan

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.

Control environmental education

Behavioral

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

Phthalate conversation

Behavioral

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

Environmental exposures conversation

Behavioral

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

Primary outcomes

  1. Baseline phthalate environmental health literacy

    Time frame: Up to 2 weeks

    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.

  2. Change from baseline phthalate environmental health literacy

    Time frame: Up to 4 weeks

    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.

  3. Baseline urinary biomarkers of phthalate exposure

    Time frame: Up to 2 weeks

    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.

  4. Change in urinary biomarkers of phthalate exposure

    Time frame: Up to 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Registry information

Acronym: DEEP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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