AzTrials
AzTrials

Obesity &Amp;Amp;Amp; OverweightLiveWellNCT07560579

Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity

A study testing Educational curriculum, Weight loss Application and Urinary EDC metabolite testing in people with Obesity &Amp;Amp;Amp; Overweight and Environmental Exposure, run by Million Marker Wellness, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Educational curriculum, Weight loss Application and Urinary EDC metabolite testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteUnited States
Study dates
18 Aug 2025to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Million Marker

    Berkeley, California, 94704

Other trials in United States

About this study

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.
Read the detailed description

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.

Being tested
Educational curriculum, Weight loss Application, Urinary EDC metabolite testing, Siphox clinic biomarker test, Weight loss reporting
Keywords
EDCs, Weightloss, Endocrine Disrupting Chemicals, phthalates, bisphenols, parabens
Medical subject headings
Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational curriculumBehavioural

    A self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum.

  • Weight loss ApplicationBehavioural

    A paid, self-directed weight loss application.

  • Urinary EDC metabolite testingDiagnostic test

    Mail-in urine samples tested for metabolites of bisphenols, phthalates, parabens, and oxybenzone.

  • Siphox clinic biomarker testDiagnostic test

    Mail-in blood samples tested for clinical biomarkers.

  • Weight loss reportingDiagnostic test

    Self-reported weight loss.

Study groups in NCT07560579
Study groupRoleWhat they receive
Weight Loss GroupExperimentalIndividuals 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.
Receives: Behavioral: Weight loss Application; Diagnostic Test: Urinary EDC metabolite testing; Diagnostic Test: Siphox clinic biomarker test; Diagnostic Test: Weight loss reporting
EDC Reduction Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: Educational curriculum; Diagnostic Test: Urinary EDC metabolite testing; Diagnostic Test: Siphox clinic biomarker test; Diagnostic Test: Weight loss reporting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Pre and post intervention (4 months between measurements)

  2. 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).

    Measured: Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)

  3. Changes in EDC metabolites after the intervention

    Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone

    Measured: Pre and post intervention (4 months in between measurements)

Secondary outcomes (2)
  1. 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: Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)

  2. Changes in Weight Loss Literacy

    The Weight Loss Literacy questions ask participants knowledge on dietary questions related to weight loss.

    Measured: Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start18 Aug 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07560579
Sponsor's protocol ID
20251480
Other IDs
1R43ES037592-01
Acronym
LiveWell
Status last verified
Oct 2026
First submitted
2 Dec 2025
Last updated
6 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34863252
  • Behr H, Earl S, Ho AS, Lee J, Mitchell ES, McCallum M, May CN, Michaelides A. Changes in Health-Promoting Behaviors and Their Association with Weight Loss, Retention, and Engagement on a Digital Program: Prospective Study. Nutrients. 2022 Nov 14;14(22):4812. doi: 10.3390/nu14224812.

    PubMed 36432498
  • Carey A, Yang Q, DeLuca L, Toro-Ramos T, Kim Y, Michaelides A. The Relationship Between Weight Loss Outcomes and Engagement in a Mobile Behavioral Change Intervention: Retrospective Analysis. JMIR Mhealth Uhealth. 2021 Nov 8;9(11):e30622. doi: 10.2196/30622.

    PubMed 34747706
  • Chin SO, Keum C, Woo J, Park J, Choi HJ, Woo JT, Rhee SY. Successful weight reduction and maintenance by using a smartphone application in those with overweight and obesity. Sci Rep. 2016 Nov 7;6:34563. doi: 10.1038/srep34563.

    PubMed 27819345
  • Yilmaz B, Terekeci H, Sandal S, Kelestimur F. Endocrine disrupting chemicals: exposure, effects on human health, mechanism of action, models for testing and strategies for prevention. Rev Endocr Metab Disord. 2020 Mar;21(1):127-147. doi: 10.1007/s11154-019-09521-z.

    PubMed 31792807
  • Vandiver KM, Erdei E, Mayer AG, Ricciardi C, O'Leary M, Burke K, Zelikoff JT. Building Environmental Health and Genomics Literacy among Healthcare Providers Serving Vulnerable Communities: An Innovative Educational Framework. Int J Environ Res Public Health. 2022 Jan 14;19(2):929. doi: 10.3390/ijerph19020929.

    PubMed 35055751
  • Grindler NM, Allshouse AA, Jungheim E, Powell TL, Jansson T, Polotsky AJ. OBGYN screening for environmental exposures: A call for action. PLoS One. 2018 May 16;13(5):e0195375. doi: 10.1371/journal.pone.0195375. eCollection 2018.

    PubMed 29768418
  • Finn S, O'Fallon L. The Emergence of Environmental Health Literacy-From Its Roots to Its Future Potential. Environ Health Perspect. 2017 Apr;125(4):495-501. doi: 10.1289/ehp.1409337. Epub 2015 Jun 30.

    PubMed 26126293
  • Lichtveld MY, Covert HH, Sherman M, Shankar A, Wickliffe JK, Alcala CS. Advancing Environmental Health Literacy: Validated Scales of General Environmental Health and Environmental Media-Specific Knowledge, Attitudes and Behaviors. Int J Environ Res Public Health. 2019 Oct 28;16(21):4157. doi: 10.3390/ijerph16214157.

    PubMed 31661913
  • Rochester JR, Kwiatkowski CF, Neveux I, Dabe S, Hatcher KM, Lathrop MK, Daza EJ, Eskenazi B, Grzymski JJ, Hua J. A Personalized Intervention to Increase Environmental Health Literacy and Readiness to Change in a Northern Nevada Population: Effects of Environmental Chemical Exposure Report-Back. Int J Environ Res Public Health. 2024 Jul 11;21(7):905. doi: 10.3390/ijerph21070905.

    PubMed 39063482
  • Liu G, Dhana K, Furtado JD, Rood J, Zong G, Liang L, Qi L, Bray GA, DeJonge L, Coull B, Grandjean P, Sun Q. Perfluoroalkyl substances and changes in body weight and resting metabolic rate in response to weight-loss diets: A prospective study. PLoS Med. 2018 Feb 13;15(2):e1002502. doi: 10.1371/journal.pmed.1002502. eCollection 2018 Feb.

    PubMed 29438414
  • Song Y, Hauser R, Hu FB, Franke AA, Liu S, Sun Q. Urinary concentrations of bisphenol A and phthalate metabolites and weight change: a prospective investigation in US women. Int J Obes (Lond). 2014 Dec;38(12):1532-7. doi: 10.1038/ijo.2014.63. Epub 2014 Apr 11.

    PubMed 24722546
  • van der Meer TP, Thio CHL, van Faassen M, van Beek AP, Snieder H, van Berkum FNR, Kema IP, Makris KC, Wolffenbuttel BHR, van Vliet-Ostaptchouk JV. Endocrine disrupting chemicals during diet-induced weight loss - A post-hoc analysis of the LOWER study. Environ Res. 2021 Jan;192:110262. doi: 10.1016/j.envres.2020.110262. Epub 2020 Oct 10.

    PubMed 33045228
  • Cardenas A, Hauser R, Gold DR, Kleinman KP, Hivert MF, Fleisch AF, Lin PD, Calafat AM, Webster TF, Horton ES, Oken E. Association of Perfluoroalkyl and Polyfluoroalkyl Substances With Adiposity. JAMA Netw Open. 2018 Aug 3;1(4):e181493. doi: 10.1001/jamanetworkopen.2018.1493.

    PubMed 30646133
  • Kim KY, Lee E, Kim Y. The Association between Bisphenol A Exposure and Obesity in Children-A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2019 Jul 15;16(14):2521. doi: 10.3390/ijerph16142521.

    PubMed 31311074

Questions about this trial

What is this clinical trial studying?

A study testing Educational curriculum, Weight loss Application and Urinary EDC metabolite testing in people with Obesity &Amp;Amp;Amp; Overweight and Environmental Exposure, run by Million Marker Wellness, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in weight after intervention. (time frame: Pre and post intervention (4 months between measurements)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07560579, which also lists 56 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in