xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06032143</url>
    </required_header>
    <id_info>
      <org_study_id>IRB23-0748</org_study_id>
      <nct_id>NCT06032143</nct_id>
    </id_info>
    <brief_title>Doulas as Environmental Educators and Partners Study</brief_title>
    <acronym>DEEP</acronym>
    <official_title>Doulas as Environmental Educators and Partners Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Harvard School of Public Health (HSPH)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Harvard School of Public Health (HSPH)</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aims of this project are:&#xD;
  &#xD;
        Aim 1: Determine the extent to which an environmental health literacy educational&#xD;
        intervention designed for doulas improves their environmental health literacy of endocrine&#xD;
        disrupting chemicals (EDCs) in personal care products.&#xD;
  &#xD;
        Hypothesis 1a. Doulas who participate in an environmental health literacy course will have a&#xD;
        higher environmental health literacy score based on quantitative questionnaire evaluation&#xD;
        post-course compared to pre-course.&#xD;
  &#xD;
        Hypothesis 1b. Doulas who participate in the environmental health literacy course will have a&#xD;
        higher environmental health literacy scores post-course compared to doulas who do not take&#xD;
        the environmental health literacy course.&#xD;
  &#xD;
        Aim 2: Determine the extent to which pregnant people counseled by doulas with training in&#xD;
        environmental health literacy have higher environmental health literacy scores and lower&#xD;
        usage of personal care products containing EDCs following doula counseling.&#xD;
  &#xD;
        Hypothesis 2a. Compared to pregnant people not counseled by doulas on EDCs in personal care&#xD;
        products, pregnant individuals counseled by doulas on these EDCs will have improved scores in&#xD;
        environmental health literacy.&#xD;
  &#xD;
        Hypothesis 2b. Compared to pregnant people not counseled by doulas on EDCs in personal care&#xD;
        products, pregnant individuals receiving counseling will use fewer personal care products&#xD;
        associated with containing EDCs based on a validated questionnaire.&#xD;
  &#xD;
        Aim 3: Determine whether concentrations of EDC biomarkers decreased after the intervention&#xD;
        for the intervention group.&#xD;
  &#xD;
        Hypothesis 3: Urinary phthalate metabolite concentrations will be lower post-course compared&#xD;
        to pre-course for the intervention group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Compared to other racial/ethnic groups, non-Hispanic black women have significantly higher&#xD;
        concentrations of endocrine disrupting chemicals (EDCs) found in personal care products,&#xD;
        including phthalates and parabens These EDCs are linked to a variety of adverse reproductive&#xD;
        health outcomes that range from early puberty to preterm birth to hot flashes-all conditions&#xD;
        that disproportionately impact black women and their long-term health.&#xD;
  &#xD;
        Pregnancy is a particularly sensitive window of exposure to EDCs due to normal physiologic&#xD;
        changes that alter the body's lipid and glucose metabolism, vasculature, inflammatory, and&#xD;
        coagulation responses. Sadly, pregnancy holds some of the most shocking racial/ethnic health&#xD;
        disparities, including a 50% increased risk of preterm birth, up to 2-fold increased risk of&#xD;
        preeclampsia, and 3-fold increased risk of maternal mortality. Gaps in health care access&#xD;
        have been documented as important contributors to these adverse health outcomes, but little&#xD;
        research has evaluated the critical gap in environmental health information, particularly&#xD;
        information linked to knowledge, awareness, and action related to EDC exposures. In black&#xD;
        pregnant people, doulas have increasingly served an important role in filling health care&#xD;
        gaps by providing access, advocacy, support, and education at this sensitive window. Yet,&#xD;
        doulas often are not equipped to provide key environmental health information around chemical&#xD;
        exposures that are higher in black women. If doulas' environmental health literacy of&#xD;
        personal care product EDCs linked to adverse pregnancy outcomes was improved, then pregnant&#xD;
        people in their care could benefit from reduced exposure to these chemicals and improved&#xD;
        pregnancy outcomes. With this, the investigators intend to leverage the supportive advocacy&#xD;
        and educational role doulas provide to black pregnant people to improve EDC environmental&#xD;
        health literacy by partnering with Black Millennials 4 Flint organization to 1) educate&#xD;
        doulas on EDCs; 2) utilize this newly gained knowledge in a clinical setting for doulas to&#xD;
        counsel pregnant people on personal care product EDC chemicals; 3) measure environmental&#xD;
        health literacy in doulas and the pregnant people they counsel; 4) evaluate urinary phthalate&#xD;
        metabolite concentrations before and after the intervention. To conduct this intervention,&#xD;
        the investigators will leverage a personal care product EDC module developed by the Harvard&#xD;
        Chan's Environmental Reproductive Justice Lab (PI: Dr. Tamarra James-Todd). The investigators&#xD;
        will also utilize an environmental health literacy questionnaire, as well as other previously&#xD;
        validated quantitative and qualitative data collection tools. The aims of this project are:&#xD;
  &#xD;
        Aim 1: Determine the extent to which an environmental health literacy educational&#xD;
        intervention designed for doulas improves their environmental health literacy of EDCs in&#xD;
        personal care products Hypothesis 1a. Doulas who participate in an environmental health&#xD;
        literacy course will have a higher environmental health literacy score based on quantitative&#xD;
        questionnaire evaluation post-course compared to pre-course Hypothesis 1b. Doulas who&#xD;
        participate in the environmental health literacy course will have a higher environmental&#xD;
        health literacy scores post-course compared to doulas who do not take the environmental&#xD;
        health literacy course Aim 2: Determine the extent to which pregnant people counseled by&#xD;
        doulas with training in environmental health literacy have higher environmental health&#xD;
        literacy scores and lower usage of personal care products containing EDCs following doula&#xD;
        counseling Hypothesis 2a. Compared to pregnant people not counseled by doulas on EDCs in&#xD;
        personal care products, pregnant individuals counseled by doulas on these EDCs will have&#xD;
        improved scores in environmental health literacy Hypothesis 2b. Compared to pregnant people&#xD;
        not counseled by doulas on EDCs in personal care products, pregnant individuals receiving&#xD;
        counseling will use fewer personal care products associated with containing EDCs based on a&#xD;
        validated questionnaire Aim 3: Determine whether concentrations of EDC biomarkers decreased&#xD;
        after the intervention for the intervention group.&#xD;
  &#xD;
        Hypothesis 3: Urinary phthalate metabolite concentrations will be lower post-course compared&#xD;
        to pre-course for the intervention group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Baseline phthalate environmental health literacy</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline phthalate environmental health literacy</measure>
      <time_frame>Up to 4 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline urinary biomarkers of phthalate exposure</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in urinary biomarkers of phthalate exposure</measure>
      <time_frame>Up to 4 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Health Knowledge, Attitudes, Practice</condition>
    <arm_group>
      <arm_group_label>Intervention Doulas</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Doulas</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Doulas randomized to the control group will access a worksheet about an alternative environmental exposure and the relationship with reproductive health.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention Pregnant Individuals</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pregnant individuals working with intervention doulas will be asked to have a conversation with their doulas about environmental chemicals (phthalates).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Pregnant Individuals</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Pregnant individuals working with control doulas will be asked to have a conversation with their doulas about environmental chemicals (distinct from phthalates).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Online educational phthalate course</intervention_name>
      <description>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.</description>
      <arm_group_label>Intervention Doulas</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Control environmental education</intervention_name>
      <description>Participants in the control group will receive access to environmental exposures other than phthalates.</description>
      <arm_group_label>Control Doulas</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Phthalate conversation</intervention_name>
      <description>Participants in the intervention groups will be asked to engage in conversations about phthalates between doulas/pregnant individuals.</description>
      <arm_group_label>Intervention Pregnant Individuals</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Environmental exposures conversation</intervention_name>
      <description>Participants in the intervention groups will be asked to engage in conversations about environmental exposures (other than phthalates) between doulas/pregnant individuals.</description>
      <arm_group_label>Control Pregnant Individuals</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Doulas currently working with pregnant individuals &lt;30 weeks into their pregnancy&#xD;
  &#xD;
            -  Pregnant individuals working with doulas who are &lt;30 weeks into their pregnancy&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Doulas not currently working with pregnant individuals &lt;30 weeks into their pregnancy&#xD;
  &#xD;
            -  Pregnant individuals working with doulas who are beyond 30 weeks into their pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
      <investigator_full_name>Tamarra James-Todd</investigator_full_name>
      <investigator_title>Primary Investigator</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06032143
  org study id: IRB23-0748
  nct id: NCT06032143
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Baseline phthalate environmental health literacy
  time frame: Up to 2 weeks
  description: 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.
  measure: Change from baseline phthalate environmental health literacy
  time frame: Up to 4 weeks
  description: 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.
  measure: Baseline urinary biomarkers of phthalate exposure
  time frame: Up to 2 weeks
  description: 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.
  measure: Change in urinary biomarkers of phthalate exposure
  time frame: Up to 4 weeks
  description: 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.
  arm group label: Intervention Doulas
  arm group type: Experimental
  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.
  arm group label: Control Doulas
  arm group type: Sham Comparator
  description: Doulas randomized to the control group will access a worksheet about an alternative environmental exposure and the relationship with reproductive health.
  arm group label: Intervention Pregnant Individuals
  arm group type: Experimental
  description: Pregnant individuals working with intervention doulas will be asked to have a conversation with their doulas about environmental chemicals (phthalates).
  arm group label: Control Pregnant Individuals
  arm group type: Sham Comparator
  description: Pregnant individuals working with control doulas will be asked to have a conversation with their doulas about environmental chemicals (distinct from phthalates).
  intervention type: Behavioral
  intervention name: Online educational phthalate course
  description: 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.
  arm group label: Intervention Doulas
  intervention type: Behavioral
  intervention name: Control environmental education
  description: Participants in the control group will receive access to environmental exposures other than phthalates.
  arm group label: Control Doulas
  intervention type: Behavioral
  intervention name: Phthalate conversation
  description: Participants in the intervention groups will be asked to engage in conversations about phthalates between doulas/pregnant individuals.
  arm group label: Intervention Pregnant Individuals
  intervention type: Behavioral
  intervention name: Environmental exposures conversation
  description: Participants in the intervention groups will be asked to engage in conversations about environmental exposures (other than phthalates) between doulas/pregnant individuals.
  arm group label: Control Pregnant Individuals
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Harvard School of Public Health (HSPH)
  investigator full name: Tamarra James-Todd
  investigator title: Primary Investigator