Breast Cancer, Exposure During Pregnancy, Pregnancy Related
Conditions
Keywords
Hair products, Phthalates, Endocrine disrupting chemicals
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.
Interventions
BEHAVIORALEducational 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
Sponsors
National Institute of Environmental Health Sciences (NIEHS)
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Internal Dose of Urinary Phthalate 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Educational Intervention Delivery and Change in Behavior 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 | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | Educational Intervention Delivery and Change in Behavior |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants |
| Age, Continuous | 29.9 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention | Change in Internal Dose of Urinary Phthalate Metabolites | 1.9 percent change of sumLMW | Standard Deviation 0.7 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention | Change in Internal Dose of Urinary Phthalate Metabolites | -16.5 percent change in sumLMW | Standard Deviation 1.3 |
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: 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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention | Number of Participants With a Change in PAPM Stage | 26 Participants |
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: 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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention | Number of Participants With a Change in PAPM Stage | 9 Participants |
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: 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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention | Number of Participants With a Change in PAPM Stage | 5 Participants |