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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)

14 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

226

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • California
      • Berkeley, California, Estados Unidos, 94704
        • Million Marker

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Amostras de urina enviadas pelo correio testadas para metabólitos de bisfenóis, ftalatos, parabenos e oxibenzona.
A paid, self-directed weight loss application.
Mail-in blood samples tested for clinical biomarkers.
Self-reported weight loss.
Experimental: 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.
Amostras de urina enviadas pelo correio testadas para metabólitos de bisfenóis, ftalatos, parabenos e oxibenzona.
Um currículo interativo on-line autodirigido com material EDC, com acesso a treinadores ao vivo e um fórum on-line.
Mail-in blood samples tested for clinical biomarkers.
Self-reported weight loss.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in weight after intervention.
Prazo: 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
Prazo: 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)
Changes in Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention.
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Changes in 'Readiness to Change' to reduce risky behaviors after the intervention.
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Diretor de estudo: Johanna R Rochester, PhD, Million Marker Wellness

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de agosto de 2025

Conclusão Primária (Estimado)

1 de agosto de 2026

Conclusão do estudo (Estimado)

1 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

2 de dezembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de abril de 2026

Primeira postagem (Real)

1 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

Starting six months after publication

Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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