Hair Care Product Use Among Women Of Color

Hair Care Product Use Among Women Of Color: A Northern Manhattan Intervention

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Pregnancy Related; Exposure During Pregnancy
• Intervention / Treatment: Behavioral: Educational Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Community Engagement Core Community Space

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English and/or Spanish Speaking
• Pregnant women within first 4 weeks of 3rd trimester of pregnancy
• Lives within Northern Manhattan
• Women of color defined as Black or Hispanic women

Exclusion Criteria:

• Does not provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational Intervention; 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.	Behavioral: Educational Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Internal Dose of Urinary Phthalate Metabolites	Urinary phthalate metabolites will be measured through gas chromatography-mass spectrometry (GC-MS). The percent change will be calculated from baseline to follow up 1 (FU1) and presented as a summary value of all low molecular weight phthalates (sumLMW). This outcome is calculated from the [(mean of FU1 - Mean of Baseline)/Mean of FU1]* 100. To calculate the sumLMW the investigators divided each metabolite by its molecular weight, summed the metabolites together, then multiplied by the average molecular weight of the metabolites.	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)
Change in Internal Dose of Urinary Phthalate Metabolites	Urinary phthalate metabolites will be measured through gas chromatography-mass spectrometry (GC-MS). The percent change will be calculated from baseline to Follow up 2 (FU2) and presented as a summary value of all low molecular weight phthalates (sumLMW). This outcome is calculated from the [(mean of FU2 - Mean of Baseline)/Mean of FU2]* 100. To calculate the sumLMW the investigators divided each metabolite by its molecular weight, summed the metabolites together, then multiplied by the average molecular weight of the metabolites.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Change in PAPM Stage	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. The number of participants that show a change (progression) will be reported.	Baseline (early Trimester 3 i.e. week 27-31 of pregnancy ) and Immediate Post-Intervention (1-2 weeks post Baseline)
Number of Participants With a Change in PAPM Stage	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. The number of participants that show a change (progression) will be reported.	Immediate Post-Intervention (1-2 weeks post Baseline) & Follow up 1 (late Trimester 3 i.e. 4-6 weeks post baseline)
Number of Participants With a Change in PAPM Stage	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. The number of participants that show a change (progression) will be reported.	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)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Jasmine A. McDonald, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): June 3, 2022

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Phthalates; Hair products; Endocrine disrupting chemicals
• Other Study ID Numbers: AAAS9968; 5P30ES009089 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan 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 Sharing Time Frame: End of study
• IPD Sharing Access Criteria: De-identified or coded data only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No