Clinical trial NCT04493892: Hair Care Product Use Among Women Of Color
Official title: Hair Care Product Use Among Women Of Color: A Northern Manhattan Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Pregnancy Related
Exposure During Pregnancy
Keywords: Hair products
Phthalates
Endocrine disrupting chemicals
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2020-07-30
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Internal Dose of Urinary Phthalate Metabolites
timeFrame: 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)
measure: Change in Internal Dose of Urinary Phthalate Metabolites
timeFrame: 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 outcomes:
measure: Number of Participants With a Change in PAPM Stage
timeFrame: Baseline (early Trimester 3 i.e. week 27-31 of pregnancy ) and Immediate Post-Intervention (1-2 weeks post Baseline)
measure: Number of Participants With a Change in PAPM Stage
timeFrame: Immediate Post-Intervention (1-2 weeks post Baseline) & Follow up 1 (late Trimester 3 i.e. 4-6 weeks post baseline)
measure: Number of Participants With a Change in PAPM Stage
timeFrame: 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)
Other outcomes:
Locations:
city: New York
country: United States
facility: Community Engagement Core Community Space
state: New York
Study officials:
affiliation: Columbia University
name: Jasmine A. McDonald, PhD
role: PRINCIPAL_INVESTIGATOR
References: