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Doulas As Environmental Educators and Partners Study (DEEP)

P

President and Fellows of Harvard College

Status

Enrolling

Conditions

Health Knowledge, Attitudes, Practice

Treatments

Behavioral: Online educational phthalate course
Behavioral: Phthalate conversation
Behavioral: Environmental exposures conversation
Behavioral: Control environmental education

Study type

Interventional

Funder types

Other

Identifiers

NCT06032143
IRB23-0748

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 4 patient groups

Intervention Doulas
Experimental group
Description:
Doulas randomized to the intervention group will engage in a one-hour online course about exposure to phthalates and the relationship with reproductive health.
Treatment:
Behavioral: Online educational phthalate course
Control Doulas
Sham Comparator group
Description:
Doulas randomized to the control group will access a worksheet about an alternative environmental exposure and the relationship with reproductive health.
Treatment:
Behavioral: Control environmental education
Intervention Pregnant Individuals
Experimental group
Description:
Pregnant individuals working with intervention doulas will be asked to have a conversation with their doulas about environmental chemicals (phthalates).
Treatment:
Behavioral: Phthalate conversation
Control Pregnant Individuals
Sham Comparator group
Description:
Pregnant individuals working with control doulas will be asked to have a conversation with their doulas about environmental chemicals (distinct from phthalates).
Treatment:
Behavioral: Environmental exposures conversation

Trial contacts and locations

1

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Central trial contact

Kathryn Tomsho, PhD

Data sourced from clinicaltrials.gov

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