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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43ES037592-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
| Mayo Clinic | OTHER |
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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:
All three aims will assess EDC metabolites (vial mail-in urine test), weight loss (via self-reporting), and clinical biomarkers (via mail-in blood test, Siphox) as well as the effects of the interventions on improving EDC and weight related health literacy, readiness to change, adoption of healthy behaviors, and wellness (stress, sleep, general health, physical activity, social support, and financial well being) assessed via validated surveys before and after the interventions. Forty individuals with BMI ≥25 kg/m2 will be recruited (via the MM newsletter and social media) to each arm (N=80 total). Urinary EDC metabolites will be measured via MM mail-in EDC testing kit pre- and post-intervention and weight will be self-reported in both arms. The hypothesis is EDC exposures will be reduced and weight will decrease after intervention, in both arms and that post-intervention, participants will improve EDC and weight related health literacy, readiness to change, adoption of healthy behaviors, and wellness, in each of the arms. Our target population is individuals who are overweight or obese (i.e. BMI ≥25 kg/m2). The eligibility criteria include the following: a) age 18 and above; b) have access to a computer/ smartphone and a scale; c) not pregnant or breastfeeding; d) in good health, free from known diabetes; kidney, liver, cardiac, or pulmonary disease; or cancer; e) non-smoker; f) able to understand written and spoken English; g) willing to complete all study assessments. The MM team will recruit individuals (40 for each intervention arm). Participants will receive the MM test kits and intervention programs and weight loss application services. The study aims to enroll equal numbers of male and female participants and 30% non-white participants to match the US census, matched and randomized to each intervention arm. Individuals who respond to our posts will be sent recruitment emails with eligibility criteria screening questions. Upon completion of the screening questions, participants who meet the eligibility criteria will sign an electronic consent form to participate in the study. Consented participants will be randomized into the two intervention groups by using block randomization and will be sent a link to complete the baseline surveys. Once the baseline survey is completed, participants will be mailed the MM urine test kit and Siphox blood spot test kit. Participants in the EDC group will receive their results approximately 4 weeks after returning their kit. Several emails will be sent to the participants to update them on their sample and report statuses and keep them engaged. Once they have completed the 16-week intervention, participants will be sent the second kits and go through the same process again and submit their post-intervention samples.
Participants in both arms will complete surveys online at baseline and 12 weeks after the start of the intervention (post-intervention). Demographic questions include participants' age, level of education, income, height and weight, self-assessed health status, smoking status, alcohol intake, and exposure to other toxic substances (e.g. dangerous chemicals, radiation). Height and weight will be computed into BMI for analysis of change over time. The study will measure participants' EDC and weight-related health literacy, readiness to change, self-reported behavior change, and wellness. During the post-intervention survey only, participants will be asked about how their behavior changed as a result of the intervention. The study will also evaluate the usability of the testing and report-back platform and participants' experiences (engagement, satisfaction, and retention) using the System Usability Scale and other participant satisfaction questions.
EDC Reduction Intervention Group: Participants in this group will be required to attend 2 food/product/lifestyle audit sessions, complete at least 6 out of 12 modules in the intervention course and complete pre-post intervention surveys. Participants will be guided through this journey from our online instructions, online video tutorials, extensive educational materials, and email communication.
Weight Loss Group: Individuals will be recruited to this following the same eligibility and recruitment parameters of the EDC intervention group. The weight loss intervention group will use a weight loss application for 12 weeks. MM will pay for the subscription. Participants will receive a MM test kit and Siphox kit at baseline, before starting the weight loss intervention, and after 12 weeks of engaging with the weight loss program. They will not undergo any EDC lifestyle auditing or coaching. Additionally, in order to reduce bias, these participants will not receive the results of their EDC testing and recommendations for reducing exposure until after the study has been completed, at which point they will receive both their baseline and post-intervention EDC exposure results. The Weight Loss group will also fill out the same baseline and post-intervention surveys as above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss Group | Experimental | Individuals will be recruited to this following the same eligibility and recruitment parameters of the EDC intervention group. The weight loss intervention group will use a weight loss application for 12 weeks. Participants will receive a MM test kit and Siphox kit at baseline, before starting the weight loss intervention, and after 12 weeks of engaging with the weight loss program. They will not undergo any EDC lifestyle auditing. Additionally, in order to reduce bias, these participants will not receive the results of their EDC testing and recommendations for reducing exposure until after the study has been completed, at which point they will receive both their baseline and post-intervention EDC exposure results. |
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| EDC Reduction Intervention Group | Experimental | Participants will be required to attend 2 food/product/lifestyle audit sessions, complete at least 6 out 12 of the modules in the intervention course and complete pre-post intervention surveys. Participants will be guided through this journey from our online instructions, online video tutorials, extensive educational materials, and email communication. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational curriculum | Behavioral | A self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in weight after intervention. | 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). | Pre and post intervention (4 months between measurements) |
| Changes in EDC metabolites after the intervention | Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone | Pre and post intervention (4 months in between measurements) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) 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). |
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Inclusion Criteria:
Exclusion Criteria:
All
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| Name | Affiliation | Role |
|---|---|---|
| Johanna R Rochester, PhD | Million Marker Wellness | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Million Marker | Berkeley | California | 94704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34863252 | Background | Ouazzani HE, Rouillon S, Venisse N, Sifer-Riviere L, Dupuis A, Cambien G, Ayraud-Thevenot S, Gourgues AS, Pierre-Eugene P, Pierre F, Rabouan S; DisProSE Group; Migeot V, Albouy-Llaty M. Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy-PREVED study: study protocol for a randomized controlled trial. Trials. 2021 Dec 4;22(1):876. doi: 10.1186/s13063-021-05813-5. | |
| 36432498 | Background |
| Label | URL |
|---|---|
| National Report on Human Exposure to Environmental Chemicals; National Health and Nutrition Examination Survey ( | View source |
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Million Marker will disseminate research results and findings to the scientific community through presentations at scientific meetings and conferences and publications in academic journals, as well as through the mass media and online postings. The Principal Investigator of this study will make data and associated documentation/metadata available to external researchers under a data-sharing agreement in which a specific commitment is made to use the data for research purposes only, to not provide the data to a third party or distribute it in any form, and to properly acknowledge the source of funding for the collection of the data and the researchers involved in this study.
Starting six months after publication
Researchers must submit an acceptable research plan (goals of the proposed research, the specific hypotheses to be examined, justification for research and methods), be affiliated with a recognized research institution, have demonstrated expertise in the area of the proposed research project, and receive independent approval from their governing institutional review board. Data will be available for use only to answer the specific question(s) indicated in the research plan. The researchers must provide a list of variable names and an outline of how research findings will be disseminated; and will be asked to sign a data-sharing agreement that commits to: 1) not attempt to identify any individual participant, 2) secure the data using appropriate software technology, 3) and destroy or return all data once analyses are complete. All final datasets will be de-identified. Final authorship on manuscripts will require review and approval by the Principal Investigators of this study.
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| Weight loss Application | Behavioral | A paid, self-directed weight loss application. |
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| Urinary EDC metabolite testing | Diagnostic Test | Mail-in urine samples tested for metabolites of bisphenols, phthalates, parabens, and oxybenzone. |
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| Siphox clinic biomarker test | Diagnostic Test | Mail-in blood samples tested for clinical biomarkers. |
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| Weight loss reporting | Diagnostic Test | Self-reported weight loss. |
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| Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention) |
| Changes in 'Readiness to Change' to reduce risky behaviors after the intervention. | The Readiness to Change question asks participants to choose the response (sentence) that most accurately describes their current efforts and interest in limiting their exposure to harmful chemicals. Responses will be coded from 1 to 5 with 5 reflecting greater readiness to reduce risky behaviors. | Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention) |
| Changes in Weight Loss Literacy | The Weight Loss Literacy questions ask participants knowledge on dietary questions related to weight loss. | Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention) |
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| 32534645 | Background | Department of Error. Lancet. 2020 Jun 13;395(10240):1834. doi: 10.1016/S0140-6736(19)32947-2. No abstract available. |
| 29865233 | Background | Street ME, Angelini S, Bernasconi S, Burgio E, Cassio A, Catellani C, Cirillo F, Deodati A, Fabbrizi E, Fanos V, Gargano G, Grossi E, Iughetti L, Lazzeroni P, Mantovani A, Migliore L, Palanza P, Panzica G, Papini AM, Parmigiani S, Predieri B, Sartori C, Tridenti G, Amarri S. Current Knowledge on Endocrine Disrupting Chemicals (EDCs) from Animal Biology to Humans, from Pregnancy to Adulthood: Highlights from a National Italian Meeting. Int J Mol Sci. 2018 Jun 2;19(6):1647. doi: 10.3390/ijms19061647. |
| 22419778 | Background | Vandenberg LN, Colborn T, Hayes TB, Heindel JJ, Jacobs DR Jr, Lee DH, Shioda T, Soto AM, vom Saal FS, Welshons WV, Zoeller RT, Myers JP. Hormones and endocrine-disrupting chemicals: low-dose effects and nonmonotonic dose responses. Endocr Rev. 2012 Jun;33(3):378-455. doi: 10.1210/er.2011-1050. Epub 2012 Mar 14. |
| 26544531 | Background | Gore AC, Chappell VA, Fenton SE, Flaws JA, Nadal A, Prins GS, Toppari J, Zoeller RT. EDC-2: The Endocrine Society's Second Scientific Statement on Endocrine-Disrupting Chemicals. Endocr Rev. 2015 Dec;36(6):E1-E150. doi: 10.1210/er.2015-1010. Epub 2015 Nov 6. |
| Million Marker | View source |
| Siphox Test | View source |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
Not provided
Not provided