Intervention to Reduce Bisphenol A Exposure in Women

Study Overview
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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.

Official Title
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Intervention to Reduce Bisphenol A Exposure in Women

Conditions
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Environmental Exposure

Intervention / Treatment
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* Behavioral: Face-to-Face Meetings
* Behavioral: Email Only


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants randomized to intervention or control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Email Only<br>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<br>* Participants received health and fitness education.<br>|
| Experimental: Face-to-Face Meetings<br>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<br>* Participants received health and fitness education, and a face-to-face 3-week intervention to reduce bisphenol exposure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Urine BPS and BPF at 3-weeks | Change in urinary BPS and BPF measured at baseline and 3-weeks | 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 | Overnight fasted weight at baseline (date of randomization) and 3-weeks |