<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/NCT04493892</url>
  </required_header>
  <id_info>
    <org_study_id>AAAS9968</org_study_id>
    <nct_id>NCT04493892</nct_id>
  </id_info>
  <brief_title>Hair Care Product Use Among Women Of Color</brief_title>
  <official_title>Hair Care Product Use Among Women Of Color: A Northern Manhattan Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</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 purpose of this study is to reduce use of personal care products that contain endocrine&#xD;
      disrupting chemicals among women. For this pilot intervention, the investigators focus on the&#xD;
      hair care product class of personal care products, the reduction in use of&#xD;
      phthalate-containing Hair Care Products (HCPs) and use among pregnant Women of Color (WOC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endocrine disruptor chemicals (EDC) disrupt reproductive development and increase cancer risk&#xD;
      through their ability to have a direct, indirect, or interactive action on cellular processes&#xD;
      within the mammary tissues. EDCs may have the most influence during periods of dynamic&#xD;
      structural and functional changes in the mammary glands, such as during pregnancy and the&#xD;
      postpartum windows. Hair care products (HCPs) are a class of personal care products (PCPs)&#xD;
      that contain EDCs; there are stark differences in HCP use by race. Differences in hair&#xD;
      texture may explain differences in use. Nevertheless, of major concern, clinical,&#xD;
      epidemiological, and laboratory studies have suggested HCPs are associated with earlier&#xD;
      pubertal events, where the timing of pubertal maturation is an established risk factor for&#xD;
      breast cancer (BC) risk. Additional studies have shown that compared to infrequent users,&#xD;
      women classified as moderate or frequent users of PCPs had a 10-15% higher BC risk, dark hair&#xD;
      dye is associated with a 52-72% increased BC risk, a history of chemical relaxer or&#xD;
      straightener use is associated with a 64-74% increase in BC risk, and in 454 Mexican women&#xD;
      (233 cases) urinary concentrations of monoethyl phthalate (MEP) were positively associated&#xD;
      with BC, with stronger associations observed for pre-menopausal women. Evidence is emerging&#xD;
      on EDC exposures across the pregnancy/postpartum periods. This is of importance because while&#xD;
      pregnancy is associated with a long-term reduced risk of BC, it also confers an increased&#xD;
      risk of BC for at least a decade after birth. EDC exposure during this period of increased&#xD;
      risk could promote 'activation' effects for BC following pregnancy. In pregnant women, PCP&#xD;
      use is correlated with higher concentrations of urinary phthalates, urinary metabolite&#xD;
      concentrations vary by PCP type, and urinary metabolite concentrations differ by&#xD;
      sociodemographic factors and across racial and ethnic populations.&#xD;
&#xD;
      Unfortunately, few studies examine HCP-associated EDC exposure across the&#xD;
      pregnancy/postpartum periods and no study has implemented a behavioral intervention. An&#xD;
      intervention during pregnancy on EDC exposures and HCPs could have intergenerational health&#xD;
      implications.&#xD;
&#xD;
      An intervention to reduce phthalate exposures during the pregnancy/postpartum window would&#xD;
      have both fetal/early and maternal health implications. First, behavioral changes during&#xD;
      pregnancy could mitigate EDC exposures that exert in utero effects that may program long term&#xD;
      risk for hormone-related disease for the child. Second, behavioral changes could reduce&#xD;
      'activation' effects for BC following pregnancy. Pregnant women are primed to change&#xD;
      behaviors for their babies' health.&#xD;
&#xD;
      Therefore, the investigators propose an educational intervention for prenatal women of color&#xD;
      in Northern Manhattan on HCPs and EDC exposures with an assessment of behavioral change via&#xD;
      self-report and urinary phthalate concentrations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2021</start_date>
  <completion_date type="Actual">June 3, 2022</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in internal dose of urinary phthalate metabolites</measure>
    <time_frame>Baseline (early Trimester 3 i.e. week 27-31 of pregnancy) and Follow up 1 (late Trimester 3 i.e. 4-6 weeks post baseline)</time_frame>
    <description>Urinary phthalate metabolites will be measured through gas chromatography-mass spectrometry (GC-MS). The change will be calculated from baseline to F/U 1 and Baseline to F/U2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in internal dose of urinary phthalate metabolites</measure>
    <time_frame>Baseline (early Trimester 3 i.e. week 27-31 of pregnancy) and Follow up 2 (1-month postpartum i.e. approx 3 months from baseline).</time_frame>
    <description>Urinary phthalate metabolites will be measured through gas chromatography-mass spectrometry (GC-MS). The change will be calculated from baseline to F/U 1 and Baseline to F/U2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PAPM stage</measure>
    <time_frame>Baseline (early Trimester 3 i.e. week 27-31 of pregnancy ) and Immediate Post-Intervention (1-2 weeks post Baseline)</time_frame>
    <description>Self reported behavioral changes as assessed by the Precaution Adoption Process Model (PAPM). The questionnaire allows investigators to assess the stage at each time point. The investigators will be examining PAPM as a change in stages: ΔPAPM (categorical). Label individual change by 1-stagnant (i.e. not moving from last reported stage); 2-regresses (i.e. regressing stage(s) from last reported stage) [cannot go back to unaware]; 3-progresses (i.e. advancing stage(s) from last reported stage; this will include Stage 4); 4th category will be included for a sub analysis if large enough, 4-negative-progresses. Category 3 is a best possible outcome and 2 is the worst possible outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PAPM stage</measure>
    <time_frame>Immediate Post-Intervention (1-2 weeks post Baseline) &amp; Follow up 1 (late Trimester 3 i.e. 4-6 weeks post baseline)</time_frame>
    <description>Self reported behavioral changes as assessed by the Precaution Adoption Process Model (PAPM). The questionnaire allows investigators to assess the stage at each time point. The investigators will be examining PAPM as a change in stages: ΔPAPM (categorical). Label individual change by 1-stagnant (i.e. not moving from last reported stage); 2-regresses (i.e. regressing stage(s) from last reported stage) [cannot go back to unaware]; 3-progresses (i.e. advancing stage(s) from last reported stage; this will include Stage 4); 4th category will be included for a sub analysis if large enough, 4-negative-progresses. Category 3 is a best possible outcome and 2 is the worst possible outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PAPM stage</measure>
    <time_frame>Follow up 1 (late Trimester 3 i.e. 4-6 weeks post baseline) &amp; Follow-Up 2 (1-month postpartum i.e., approx 3 months from baseline)</time_frame>
    <description>Self reported behavioral changes as assessed by the Precaution Adoption Process Model (PAPM). The questionnaire allows investigators to assess the stage at each time point. The investigators will be examining PAPM as a change in stages: ΔPAPM (categorical). Label individual change by 1-stagnant (i.e. not moving from last reported stage); 2-regresses (i.e. regressing stage(s) from last reported stage) [cannot go back to unaware]; 3-progresses (i.e. advancing stage(s) from last reported stage; this will include Stage 4); 4th category will be included for a sub analysis if large enough, 4-negative-progresses. Category 3 is a best possible outcome and 2 is the worst possible outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PAPM stage</measure>
    <time_frame>Immediate Post-Intervention (1-2 weeks post Baseline) &amp; Follow-Up 2 (1-month postpartum i.e., approx 3 months from baseline)</time_frame>
    <description>Self reported behavioral changes as assessed by the Precaution Adoption Process Model (PAPM). The questionnaire allows investigators to assess the stage at each time point. The investigators will be examining PAPM as a change in stages: ΔPAPM (categorical). Label individual change by 1-stagnant (i.e. not moving from last reported stage); 2-regresses (i.e. regressing stage(s) from last reported stage) [cannot go back to unaware]; 3-progresses (i.e. advancing stage(s) from last reported stage; this will include Stage 4); 4th category will be included for a sub analysis if large enough, 4-negative-progresses. Category 3 is a best possible outcome and 2 is the worst possible outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Pregnancy Related</condition>
  <condition>Exposure During Pregnancy</condition>
  <arm_group>
    <arm_group_label>Educational Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants receive educational information on the potential health risk of endocrine disruptor chemicals in hair care products, specifically phthalates. Provide information on how to reduce exposure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Deliver an educational intervention on harmful chemical exposures, such as phthalates, found in hair care products, developed by the research team using empirical evidence with key informant feedback. The intervention will cover phthalates 1) Exposure through HCPs 2) Potential adverse health outcomes for the mother and child 3) Ways to reduce exposure</description>
    <arm_group_label>Educational Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English and/or Spanish Speaking&#xD;
&#xD;
          -  Pregnant women within first 4 weeks of 3rd trimester of pregnancy&#xD;
&#xD;
          -  Lives within Northern Manhattan&#xD;
&#xD;
          -  Women of color defined as Black or Hispanic women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not provide consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jasmine A. McDonald, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Community Engagement Core Community Space</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hair products</keyword>
  <keyword>Phthalates</keyword>
  <keyword>Endocrine disrupting chemicals</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Yes: There is a plan to make individual participant data (IPD) and related data dictionaries available.&#xD;
Data and samples may be used by other Columbia researchers or researchers at other institutions for future research purposes. Participants name and other identifying information will have been permanently removed from the data and samples or the data and samples will be coded and the researchers who will use them will not have access to the key that links the code to the participant. Researchers who are not Columbia University Irving Medical Center (CUIMC) researchers on this study will only be given in de-identified or coded data.</ipd_description>
    <ipd_time_frame>End of study</ipd_time_frame>
    <ipd_access_criteria>De-identified or coded data only.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04493892
org study id: AAAS9968
nct id: NCT04493892
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to reduce use of personal care products that contain endocrine
      disrupting chemicals among women. For this pilot intervention, the investigators focus on the
      hair care product class of personal care products, the reduction in use of
      phthalate-containing Hair Care Products (HCPs) and use among pregnant Women of Color (WOC).
Endocrine disruptor chemicals (EDC) disrupt reproductive development and increase cancer risk
      through their ability to have a direct, indirect, or interactive action on cellular processes
      within the mammary tissues. EDCs may have the most influence during periods of dynamic
      structural and functional changes in the mammary glands, such as during pregnancy and the
      postpartum windows. Hair care products (HCPs) are a class of personal care products (PCPs)
      that contain EDCs; there are stark differences in HCP use by race. Differences in hair
      texture may explain differences in use. Nevertheless, of major concern, clinical,
      epidemiological, and laboratory studies have suggested HCPs are associated with earlier
      pubertal events, where the timing of pubertal maturation is an established risk factor for
      breast cancer (BC) risk. Additional studies have shown that compared to infrequent users,
      women classified as moderate or frequent users of PCPs had a 10-15% higher BC risk, dark hair
      dye is associated with a 52-72% increased BC risk, a history of chemical relaxer or
      straightener use is associated with a 64-74% increase in BC risk, and in 454 Mexican women
      (233 cases) urinary concentrations of monoethyl phthalate (MEP) were positively associated
      with BC, with stronger associations observed for pre-menopausal women. Evidence is emerging
      on EDC exposures across the pregnancy/postpartum periods. This is of importance because while
      pregnancy is associated with a long-term reduced risk of BC, it also confers an increased
      risk of BC for at least a decade after birth. EDC exposure during this period of increased
      risk could promote 'activation' effects for BC following pregnancy. In pregnant women, PCP
      use is correlated with higher concentrations of urinary phthalates, urinary metabolite
      concentrations vary by PCP type, and urinary metabolite concentrations differ by
      sociodemographic factors and across racial and ethnic populations.

      Unfortunately, few studies examine HCP-associated EDC exposure across the
      pregnancy/postpartum periods and no study has implemented a behavioral intervention. An
      intervention during pregnancy on EDC exposures and HCPs could have intergenerational health
      implications.

      An intervention to reduce phthalate exposures during the pregnancy/postpartum window would
      have both fetal/early and maternal health implications. First, behavioral changes during
      pregnancy could mitigate EDC exposures that exert in utero effects that may program long term
      risk for hormone-related disease for the child. Second, behavioral changes could reduce
      'activation' effects for BC following pregnancy. Pregnant women are primed to change
      behaviors for their babies' health.

      Therefore, the investigators propose an educational intervention for prenatal women of color
      in Northern Manhattan on HCPs and EDC exposures with an assessment of behavioral change via
      self-report and urinary phthalate concentrations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in internal dose of urinary phthalate metabolites
time frame: Baseline (early Trimester 3 i.e. week 27-31 of pregnancy) and Follow up 1 (late Trimester 3 i.e. 4-6 weeks post baseline)
description: Urinary phthalate metabolites will be measured through gas chromatography-mass spectrometry (GC-MS). The change will be calculated from baseline to F/U 1 and Baseline to F/U2.
measure: Change in internal dose of urinary phthalate metabolites
time frame: Baseline (early Trimester 3 i.e. week 27-31 of pregnancy) and Follow up 2 (1-month postpartum i.e. approx 3 months from baseline).
description: Urinary phthalate metabolites will be measured through gas chromatography-mass spectrometry (GC-MS). The change will be calculated from baseline to F/U 1 and Baseline to F/U2.
measure: Change in PAPM stage
time frame: Baseline (early Trimester 3 i.e. week 27-31 of pregnancy ) and Immediate Post-Intervention (1-2 weeks post Baseline)
description: Self reported behavioral changes as assessed by the Precaution Adoption Process Model (PAPM). The questionnaire allows investigators to assess the stage at each time point. The investigators will be examining PAPM as a change in stages: ΔPAPM (categorical). Label individual change by 1-stagnant (i.e. not moving from last reported stage); 2-regresses (i.e. regressing stage(s) from last reported stage) [cannot go back to unaware]; 3-progresses (i.e. advancing stage(s) from last reported stage; this will include Stage 4); 4th category will be included for a sub analysis if large enough, 4-negative-progresses. Category 3 is a best possible outcome and 2 is the worst possible outcome.
measure: Change in PAPM stage
time frame: Immediate Post-Intervention (1-2 weeks post Baseline) & Follow up 1 (late Trimester 3 i.e. 4-6 weeks post baseline)
description: Self reported behavioral changes as assessed by the Precaution Adoption Process Model (PAPM). The questionnaire allows investigators to assess the stage at each time point. The investigators will be examining PAPM as a change in stages: ΔPAPM (categorical). Label individual change by 1-stagnant (i.e. not moving from last reported stage); 2-regresses (i.e. regressing stage(s) from last reported stage) [cannot go back to unaware]; 3-progresses (i.e. advancing stage(s) from last reported stage; this will include Stage 4); 4th category will be included for a sub analysis if large enough, 4-negative-progresses. Category 3 is a best possible outcome and 2 is the worst possible outcome.
measure: Change in PAPM stage
time frame: Follow up 1 (late Trimester 3 i.e. 4-6 weeks post baseline) & Follow-Up 2 (1-month postpartum i.e., approx 3 months from baseline)
description: Self reported behavioral changes as assessed by the Precaution Adoption Process Model (PAPM). The questionnaire allows investigators to assess the stage at each time point. The investigators will be examining PAPM as a change in stages: ΔPAPM (categorical). Label individual change by 1-stagnant (i.e. not moving from last reported stage); 2-regresses (i.e. regressing stage(s) from last reported stage) [cannot go back to unaware]; 3-progresses (i.e. advancing stage(s) from last reported stage; this will include Stage 4); 4th category will be included for a sub analysis if large enough, 4-negative-progresses. Category 3 is a best possible outcome and 2 is the worst possible outcome.
measure: Change in PAPM stage
time frame: Immediate Post-Intervention (1-2 weeks post Baseline) & Follow-Up 2 (1-month postpartum i.e., approx 3 months from baseline)
description: Self reported behavioral changes as assessed by the Precaution Adoption Process Model (PAPM). The questionnaire allows investigators to assess the stage at each time point. The investigators will be examining PAPM as a change in stages: ΔPAPM (categorical). Label individual change by 1-stagnant (i.e. not moving from last reported stage); 2-regresses (i.e. regressing stage(s) from last reported stage) [cannot go back to unaware]; 3-progresses (i.e. advancing stage(s) from last reported stage; this will include Stage 4); 4th category will be included for a sub analysis if large enough, 4-negative-progresses. Category 3 is a best possible outcome and 2 is the worst possible outcome.
arm group label: Educational Intervention
arm group type: Experimental
description: All participants receive educational information on the potential health risk of endocrine disruptor chemicals in hair care products, specifically phthalates. Provide information on how to reduce exposure.
intervention type: Behavioral
intervention name: Educational Intervention
description: Deliver an educational intervention on harmful chemical exposures, such as phthalates, found in hair care products, developed by the research team using empirical evidence with key informant feedback. The intervention will cover phthalates 1) Exposure through HCPs 2) Potential adverse health outcomes for the mother and child 3) Ways to reduce exposure
arm group label: Educational Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jasmine A. McDonald, PhD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Yes: There is a plan to make individual participant data (IPD) and related data dictionaries available.
Data and samples may be used by other Columbia researchers or researchers at other institutions for future research purposes. Participants name and other identifying information will have been permanently removed from the data and samples or the data and samples will be coded and the researchers who will use them will not have access to the key that links the code to the participant. Researchers who are not Columbia University Irving Medical Center (CUIMC) researchers on this study will only be given in de-identified or coded data.
ipd time frame: End of study
ipd access criteria: De-identified or coded data only.