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

15 maggio 2026 aggiornato da: Jenna Hua, Million Marker Wellness, Inc.

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

226

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • California
      • Berkeley, California, Stati Uniti, 94704
        • Million Marker

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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. 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.
Campioni di urina inviati per posta testati per metaboliti di bisfenoli, ftalati, parabeni e ossibenzone.
A paid, self-directed weight loss application.
Mail-in blood samples tested for clinical biomarkers.
Self-reported weight loss.
Sperimentale: EDC Reduction Intervention Group
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.
Campioni di urina inviati per posta testati per metaboliti di bisfenoli, ftalati, parabeni e ossibenzone.
Un curriculum interattivo online autodiretto di materiale EDC, con accesso a coach dal vivo e un forum online.
Mail-in blood samples tested for clinical biomarkers.
Self-reported weight loss.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in weight after intervention.
Lasso di tempo: 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).
Pre and post intervention (4 months between measurements)
Changes in EDC metabolites after the intervention
Lasso di tempo: Pre and post intervention (4 months in between measurements)
Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone
Pre and post intervention (4 months in between measurements)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention.
Lasso di tempo: 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).
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.
Lasso di tempo: Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months 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
Lasso di tempo: Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)
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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Johanna R Rochester, PhD, Million Marker Wellness

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 agosto 2025

Completamento primario (Stimato)

1 agosto 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

2 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Starting six months after publication

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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