Intervention to Reduce Bisphenol A Exposure in Women

NCT03440307 | Completed

• 1 other identifier: Cal Poly 11/12/2015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Environmental Exposure

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Urine BPA at 3-weeks

  Change in urinary BPA measured at baseline and 3-weeks

  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

  Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks

• Change from Baseline Weight at 3-weeks

  Overnight fasted weight at baseline (date of randomization) and 3-weeks

Study Arms (2)

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.

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.

Behavioral: Face-to-Face Meetings

Interventions

Face-to-Face Meetings BEHAVIORAL

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

Face-to-Face Meetings

Email Only BEHAVIORAL

Participants received health and fitness education.

Email Only

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Women have higher BPA vs. Men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \>29.9
• Age 18-50 years
• Non-smoking
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• California Polytechnic State University-San Luis Obispo: lead

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93405, United States

Location

Related Publications (1)

• 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.

  PMID: 33436090 DERIVED

Study Officials

• Debbie Hart

  Compliance/Information Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants randomized to intervention or control.

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 22, 2018
• Study Start: November 12, 2015
• Primary Completion: November 11, 2017
• Study Completion: November 11, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)