Intervention to Reduce Bisphenol A Exposure in Women

NCT ID: NCT03440307

Last Updated: 2018-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-12

Study Completion Date

2017-11-11

Brief Summary

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The purpose of this study is to determine whether a 3-week intervention reduces urinary Bisphenol A (BPA) in women with obesity

Detailed Description

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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

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Environmental Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomized to intervention or control.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Single-blinded study

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Email Only

Intervention Type BEHAVIORAL

Participants received health and fitness education.

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.

Group Type EXPERIMENTAL

Face-to-Face Meetings

Intervention Type BEHAVIORAL

Participants received health and fitness education, and a face-to-face 3-week intervention to reduce bisphenol exposure.

Interventions

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Face-to-Face Meetings

Participants received health and fitness education, and a face-to-face 3-week intervention to reduce bisphenol exposure.

Intervention Type BEHAVIORAL

Email Only

Participants received health and fitness education.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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California Polytechnic State University-San Luis Obispo

OTHER

Sponsor Role lead

Responsible Party

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Todd Hagobian

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Debbie Hart

Role: STUDY_CHAIR

Compliance/Information Officer

Locations

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California Polytechnic State University

San Luis Obispo, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33436090 (View on PubMed)

Other Identifiers

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Cal Poly 11/12/2015

Identifier Type: -

Identifier Source: org_study_id

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