Clinical trial NCT06032143: Doulas As Environmental Educators and Partners Study
Official title: Doulas As Environmental Educators and Partners Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline phthalate environmental health literacy
timeFrame: Up to 2 weeks
measure: Change from baseline phthalate environmental health literacy
timeFrame: Up to 4 weeks
measure: Baseline urinary biomarkers of phthalate exposure
timeFrame: Up to 2 weeks
measure: Change in urinary biomarkers of phthalate exposure
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard T.H. Chan School of Public Health
state: Massachusetts
Study officials:
References: