Environmental ExposureNCT03440307
Intervention to Reduce Bisphenol A Exposure in Women
A study testing Face-to-Face Meetings and Email Only in people with Environmental Exposure, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a 3-week intervention reduces urinary Bisphenol A (BPA) in women with obesity Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- Face-to-Face Meetings and Email Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2015to 11 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >29.9
- Age 18-50 years
- Non-smoking
- English speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Polytechnic State University
San Luis Obispo, California, 93405
About this study
The purpose of this study is to determine whether a 3-week intervention reduces urinary Bisphenol A (BPA) in women with obesity
Read the 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.
- Conditions
- Environmental Exposure
- Being tested
- Face-to-Face Meetings, Email Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-Face MeetingsBehavioural
Participants received health and fitness education, and a face-to-face 3-week intervention to reduce bisphenol exposure.
Email OnlyBehavioural
Participants received health and fitness education.
| Study group | Role | What they receive |
|---|---|---|
| Email Only | Placebo comparator | Participants received weekly email about health and fitness education. No face-to-face intervention, and not provided any other information about bisphenol exposure. Receives: Behavioral: Email Only |
| Face-to-Face Meetings | Experimental | 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. Receives: Behavioral: Face-to-Face Meetings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Urine BPA at 3-weeks
Change in urinary BPA measured at baseline and 3-weeks
Measured: Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks
Secondary outcomes (2)
Change from Baseline Urine BPS and BPF at 3-weeks
Change in urinary BPS and BPF measured at baseline and 3-weeks
Measured: Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks
Change from Baseline Weight at 3-weeks
Change in body weight measured at baseline and 3-weeks
Measured: Overnight fasted weight at baseline (date of randomization) and 3-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start12 Nov 2015
- Primary completion11 Nov 2017
- Study completion11 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to intervention or control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Hagobian, California Polytechnic State University-San Luis Obispo
- Investigators
- Debbie Hart, Study chair, Compliance/Information Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440307
- Sponsor's protocol ID
- Cal Poly 11/12/2015
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data in this pilot study
Publications
Hagobian T, Delli-Bovi Z, Mercado A, Bird A, Guy M, Phelan S. Development and feasibility of randomized trial to reduce urinary bisphenols in women with obesity. Pilot Feasibility Stud. 2021 Jan 12;7(1):24. doi: 10.1186/s40814-020-00744-5.
PubMed 33436090
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Reduce Bisphenol A Exposure in Women
- ClinicalTrials.gov ID
- NCT03440307
- Acronym / sponsor ID
- Cal Poly 11/12/2015
- Conditions
- Environmental Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 11 Nov 2017 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a 3-week intervention reduces urinary Bisphenol A (BPA) in women with obesity
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomized to intervention or control.
| Arm | Type | Receives |
|---|---|---|
| Email Only | Placebo comparator | Behavioral: Email OnlyParticipants received weekly email about health and fitness education. No face-to-face intervention, and not provided any other information about bisphenol exposure. |
| Face-to-Face Meetings | Experimental | Behavioral: Face-to-Face MeetingsParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI >29.9
- Age 18-50 years
- Non-smoking
- English speaking
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-Face MeetingsParticipants received health and fitness education, and a face-to-face 3-week intervention to reduce bisphenol exposure. | Behavioural | Face-to-Face Meetings |
| Email OnlyParticipants received health and fitness education. | Behavioural | Email Only |
Primary outcome
Change from Baseline Urine BPA at 3-weeks
Time frame: Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks
Change in urinary BPA measured at baseline and 3-weeks
2 secondary outcomes
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
Change from Baseline Weight at 3-weeks
Time frame: Overnight fasted weight at baseline (date of randomization) and 3-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 33436090Hagobian T, Delli-Bovi Z, Mercado A, Bird A, Guy M, Phelan S. Development and feasibility of randomized trial to reduce urinary bisphenols in women with obesity. Pilot Feasibility Stud. 2021 Jan 12;7(1):24. doi: 10.1186/s40814-020-00744-5.
- Individual participant dataSharing planned: No. No plan to share data in this pilot study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debbie Hart study chair
Compliance/Information Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face Meetings and Email Only in people with Environmental Exposure, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Urine BPA at 3-weeks (time frame: Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03440307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.