Hair Care Product Use Among Women Of Color

NCT04493892 | Completed Results

• 2 other identifiers: AAAS99685P30ES009089
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Pregnancy Related; Exposure During Pregnancy

Keywords

Hair products; Phthalates; Endocrine disrupting chemicals

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Participants With a Change in PAPM Stage

  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

  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

  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)

Study Arms (1)

Educational Intervention

EXPERIMENTAL

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

Interventions

Educational Intervention BEHAVIORAL

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

Educational Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Does not provide consent

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Community Engagement Core Community Space

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Jasmine A. McDonald
• Organization: Columbia University

jam2319@cumc.columbia.edu

12123053586

Study Officials

• Jasmine A. McDonald, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 30, 2020
• Study Start: March 31, 2021
• Primary Completion: December 15, 2021
• Study Completion: June 3, 2022
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-04

Data Sharing

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

Locations

US (1)