Active, not recruiting
Not applicable
Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity
Condition(s) studied
Obesity &Amp;Amp;Amp; OverweightEnvironmental ExposureOverweight (BMI > 25)
Investigational drug(s) / intervention(s)
Educational curriculumWeight loss ApplicationUrinary EDC metabolite testingSiphox clinic biomarker testWeight loss reporting
Educational curriculum: A self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum.
Weight loss Application: A paid, self-directed weight loss application.
Urinary EDC metabolite testing: Mail-in urine samples tested for metabolites of bisphenols, phthalates, parabens, and oxybenzone.
Siphox clinic biomarker test: Mail-in blood samples tested for clinical biomarkers.
Weight loss reporting: Self-reported weight loss.
Study summary
The goal of this study is to examine the relationship in individuals with overweight/obesity and endocrine disrupting chemical (EDC) exposure through a two-armed, randomized clinical trial. The main questions this study aims to answer are:
1. If MM's 12-week EDC intervention program (EDC testing and report-back, EDC reduction curriculum) can reduce weight?
2. If a 12-week validated digital weight loss program can reduce EDC exposures?
3. What is the effectiveness of the two interventions at reducing weight and urinary EDC metabolites? Participants will be assigned to one of these two arms. Participants will collect their urine and blood samples pre- and post-intervention, and will take a comprehensive exposure survey before sending back their samples. This exposure survey will ask about participant's weight loss literacy, environmental health literacy, product use, diet, and lifestyle behaviors.
Eligibility
Inclusion Criteria:
* BMI over 25
* Not pregnant or breast feeding
* Do not have diabetes, kidney disease, liver disease, cardiac disease, pulmonary disease or cancer.
* Do not smoke
* Not in another weight loss program or on GLP-1
* Have access to a smartphone or computer
Exclusion Criteria:
* BMI under 25
* Pregnant or breast feeding
* Have diabetes, kidney disease, liver disease, cardiac disease, pulmonary disease or cancer.
* Smoke
* In another weight loss program or on GLP-1
* Do not have access to a smartphone or computer
Primary outcome measure(s)
- Changes in weight after intervention. — Pre and post intervention (4 months between measurements)
EDC intervention that reduces EDC exposure also help individuals to lose weight. Comparing the two interventions to see which is more effective (EDC intervention or traditional weight loss intervention).
- Changes in Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention. — Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)
This surveys assesses EDC-specific environmental health literacy, based on questions in a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree) or 1 (never) to 5 (always). Responses will be reverse coded during analysis as needed so that higher numbers reflect positive outcomes (higher EDC-EHL).
- Changes in EDC metabolites after the intervention — Pre and post intervention (4 months in between measurements)
Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Million Marker |
Berkeley |
California |
|