Trial Outcomes & Findings for Hair Care Product Use Among Women Of Color (NCT NCT04493892)

Last Updated: 2024-05-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome 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)

Results posted on

2024-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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
Overall Study STARTED	46
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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
Overall Study Withdrawal by Subject	15

Baseline Characteristics

Hair Care Product Use Among Women Of Color

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Educational Intervention Delivery and Change in Behavior n=46 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29.9 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

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)

Population: 20 of 31 analyzed as urine samples were collected from 20 participants.

Outcome measures

Outcome measures
Measure	Educational Intervention n=20 Participants 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. 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
Change in Internal Dose of Urinary Phthalate Metabolites	1.9 percent change of sumLMW Standard Deviation 0.7

PRIMARY outcome

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).

Population: 20 of 31 analyzed as urine sample were collected from 20 participants.

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.

Outcome measures

Outcome measures
Measure	Educational Intervention n=20 Participants 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. 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
Change in Internal Dose of Urinary Phthalate Metabolites	-16.5 percent change in sumLMW Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline (early Trimester 3 i.e. week 27-31 of pregnancy ) and Immediate Post-Intervention (1-2 weeks post Baseline)

Population: 26 of 31 analyzed as 26 participants received the educational intervention and completed the baseline PAPM and the immediate post-PAPM.

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.

Outcome measures

Outcome measures
Measure	Educational Intervention n=26 Participants 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. 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
Number of Participants With a Change in PAPM Stage	26 Participants

SECONDARY outcome

Timeframe: Immediate Post-Intervention (1-2 weeks post Baseline) & Follow up 1 (late Trimester 3 i.e. 4-6 weeks post baseline)

Population: 12 of 31 analyzed as 12 participants completed the educational intervention and completed the immediate post intervention PAPM and the F/U1 PAPM

Outcome measures

Outcome measures
Measure	Educational Intervention n=12 Participants 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. 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
Number of Participants With a Change in PAPM Stage	9 Participants

SECONDARY outcome

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)

Population: 7 of 31 analyzed as 7 participants completed the educational intervention and completed PAPM F/U1 and PAPM F/U2

Outcome measures

Outcome measures
Measure	Educational Intervention n=7 Participants 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. 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
Number of Participants With a Change in PAPM Stage	5 Participants

Adverse Events

Educational Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jasmine A. McDonald

Columbia University

Phone: 12123053586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place