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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)

2026年8月14日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

226

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • California
      • Berkeley、California、アメリカ、94704
        • Million Marker

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
郵送された尿サンプルでは、​​ビスフェノール、フタル酸エステル、パラベン、オキシベンゾンの代謝物が検査されています。
A paid, self-directed weight loss application.
Mail-in blood samples tested for clinical biomarkers.
Self-reported weight loss.
実験的: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.
郵送された尿サンプルでは、​​ビスフェノール、フタル酸エステル、パラベン、オキシベンゾンの代謝物が検査されています。
EDC 教材の自主的なオンライン インタラクティブ カリキュラムで、ライブ コーチやオンライン フォーラムにアクセスできます。
Mail-in blood samples tested for clinical biomarkers.
Self-reported weight loss.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Changes in weight after intervention.
時間枠: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
時間枠: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.
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Changes in 'Readiness to Change' to reduce risky behaviors after the intervention.
時間枠: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
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディディレクター:Johanna R Rochester, PhD、Million Marker Wellness

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年8月18日

一次修了 (推定)

2026年8月1日

研究の完了 (推定)

2026年9月1日

試験登録日

最初に提出

2025年12月2日

QC基準を満たした最初の提出物

2026年4月27日

最初の投稿 (実際)

2026年5月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月18日

QC基準を満たした最後の更新が送信されました

2026年8月14日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

Starting six months after publication

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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