Trial Outcomes & Findings for Phthalate and Bisphenol Exposure During Minipuberty (NCT NCT05864209)
NCT ID: NCT05864209
Last Updated: 2025-06-10
Results Overview
Child urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater infant exposure to bisphenol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Month 3
Results posted on
2025-06-10
Participant Flow
Infants were not considered enrolled participants for the purpose of this study; infant urine samples were submitted voluntarily by enrolled (mother) participants at home during follow-up. Participant information (participant flow, baseline characteristics) are thus not reported for infants.
Participant milestones
| Measure |
Intervention Group
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Intervention Group
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Phthalate and Bisphenol Exposure During Minipuberty
Baseline characteristics by cohort
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.02 years
STANDARD_DEVIATION 3.96 • n=5 Participants
|
33.025 years
STANDARD_DEVIATION 13.20 • n=7 Participants
|
30.023 years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater infant exposure to bisphenol.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples
|
0.00 Log(Arbitrary Units)
Standard Deviation 0.00
|
5.43 Log(Arbitrary Units)
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater maternal exposure to bisphenol.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples
|
3.49 Log(Arbitrary Units)
Standard Deviation 2.47
|
4.74 Log(Arbitrary Units)
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples
|
27.23 microgram/gram creatinine
Standard Deviation NA
n=1 participant analyzed.
|
13.79 microgram/gram creatinine
Standard Deviation NA
n=1 participant analyzed.
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group anf 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples
|
2.91 microgram/gram creatinine
Standard Deviation 2.66
|
5.10 microgram/gram creatinine
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples
|
129.68 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed.
|
1649.72 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed.
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples
|
89.40 microgram/gram creatinine
Standard Deviation 74.36
|
53.30 microgram/gram creatinine
Standard Deviation 8.78
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples
|
24.18 microgram/gram creatinine
Standard Deviation NA
N=1 Participant analyzed.
|
161.58 microgram/gram creatinine
Standard Deviation NA
N=1 Participant analyzed.
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group anf 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples
|
63.96 microgram/gram creatinine
Standard Deviation 91.12
|
211.21 microgram/gram creatinine
Standard Deviation 126.69
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples
|
0.42 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed.
|
6.81 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed.
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=5 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples
|
8.15 microgram/gram creatinine
Standard Deviation 7.19
|
2.43 microgram/gram creatinine
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group anf 2 out of 5 in the control group were analyzed as the rest did not provide samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples
|
0.50 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
2.92 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples
|
1.90 microgram/gram creatinine
Standard Deviation 1.25
|
2.12 microgram/gram creatinine
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine.
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples
|
62.77 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
37.40 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples
|
18.02 microgram/gram creatinine
Standard Deviation 7.21
|
21.75 microgram/gram creatinine
Standard Deviation 19.88
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples
|
74.45 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
28.25 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples
|
13.07 microgram/gram creatinine
Standard Deviation 10.02
|
10.12 microgram/gram creatinine
Standard Deviation 7.04
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples
|
2.51 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
20.00 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples
|
8.27 microgram/gram creatinine
Standard Deviation 6.6
|
3.06 microgram/gram creatinine
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples
|
0.39 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
5.06 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
SECONDARY outcome
Timeframe: Month 3Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=3 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples
|
4.34 microgram/gram creatinine
Standard Deviation 3.16
|
1.37 microgram/gram creatinine
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples
|
2.09 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
1.61 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed
|
SECONDARY outcome
Timeframe: Month 3Population: 2 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=2 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples
|
1.80 microgram/gram creatinine
Standard Deviation 0.82
|
0.57 microgram/gram creatinine
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Month 3Population: 2 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=2 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=2 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples
|
0.59 microgram/gram creatinine
Standard Deviation 0.31
|
1.52 microgram/gram creatinine
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Month 3Population: Only one intervention and one control sample was collected for child urine
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service.
|
Control Group
n=1 Participants
Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream.
|
|---|---|---|
|
Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples
|
0.61 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed.
|
1.06 microgram/gram creatinine
Standard Deviation NA
N=1 participant analyzed.
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place