Hair Care Product Use Among Women Of Color

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04493892
• Other study ID #: AAAS9968
• Secondary ID: 5P30ES009089
• Status: Completed
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: June 3, 2022

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 3, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Exposure During Pregnancy
• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
United States	Community Engagement Core Community Space	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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: ?PAPM (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)
Secondary	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: ?PAPM (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)
Secondary	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: ?PAPM (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)