- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03440307
Intervention to Reduce Bisphenol A Exposure in Women
February 20, 2018 updated by: Todd Hagobian, California Polytechnic State University-San Luis Obispo
The purpose of this study is to determine whether a 3-week intervention reduces urinary Bisphenol A (BPA) in women with obesity
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is reduce BPA exposure in women.
The intervention is rooted in social cognitive theory, and is applied to environmental health.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Luis Obispo, California, United States, 93405
- California Polytechnic State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- BMI >29.9
- Age 18-50 years
- Non-smoking
- English speaking
Exclusion Criteria:
- History of infertility
- Type 2 or Type 1 diabetes
- Cardiovascular disease, or any other metabolic disease/complication
- History of major psychiatric illness, drug abuse, or unsafe dieting practices
- History of bariatric surgery
- Pregnant women or women expecting or trying to become pregnant
- Participating in other studies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Email Only
Participants received weekly email about health and fitness education.
No face-to-face intervention, and not provided any other information about bisphenol exposure.
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Participants received health and fitness education.
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Experimental: Face-to-Face Meetings
Participants met with a counselor once per week for 3-weeks to reduce bisphenol exposure.
Intervention included same weekly email about health and fitness education as Email only group, and a weekly face-to-face meetings to reduce bisphenol exposures from food, cosmetics, and packaged products.
Women provided with bisphenol-free cosmetics, hygiene, and glass food/water containers.
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Participants received health and fitness education, and a face-to-face 3-week intervention to reduce bisphenol exposure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Urine BPA at 3-weeks
Time Frame: Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks
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Change in urinary BPA measured at baseline and 3-weeks
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Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Urine BPS and BPF at 3-weeks
Time Frame: Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks
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Change in urinary BPS and BPF measured at baseline and 3-weeks
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Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks
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Change from Baseline Weight at 3-weeks
Time Frame: Overnight fasted weight at baseline (date of randomization) and 3-weeks
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Change in body weight measured at baseline and 3-weeks
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Overnight fasted weight at baseline (date of randomization) and 3-weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Debbie Hart, Compliance/Information Officer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2015
Primary Completion (Actual)
November 11, 2017
Study Completion (Actual)
November 11, 2017
Study Registration Dates
First Submitted
February 8, 2018
First Submitted That Met QC Criteria
February 14, 2018
First Posted (Actual)
February 22, 2018
Study Record Updates
Last Update Posted (Actual)
February 22, 2018
Last Update Submitted That Met QC Criteria
February 20, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Cal Poly 11/12/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share data in this pilot study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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