- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07560579
Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity (LiveWell)
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:
- If MM's 12-week EDC intervention program (EDC testing and report-back, EDC reduction curriculum) can reduce weight?
- If a 12-week validated digital weight loss program can reduce EDC exposures?
- 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
Status
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
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Berkeley, California, Estados Unidos, 94704
- Million Marker
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
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
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.
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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.
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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)
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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).
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Pre and post intervention (4 months between measurements)
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Changes in EDC metabolites after the intervention
Prazo: Pre and post intervention (4 months in between measurements)
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Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone
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Pre and post intervention (4 months in between measurements)
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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).
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Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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)
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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.
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Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)
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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)
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The Weight Loss Literacy questions ask participants knowledge on dietary questions related to 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)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Johanna R Rochester, PhD, Million Marker Wellness
Publicações e links úteis
Publicações Gerais
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- Heindel JJ, Howard S, Agay-Shay K, Arrebola JP, Audouze K, Babin PJ, Barouki R, Bansal A, Blanc E, Cave MC, Chatterjee S, Chevalier N, Choudhury M, Collier D, Connolly L, Coumoul X, Garruti G, Gilbertson M, Hoepner LA, Holloway AC, Howell G 3rd, Kassotis CD, Kay MK, Kim MJ, Lagadic-Gossmann D, Langouet S, Legrand A, Li Z, Le Mentec H, Lind L, Monica Lind P, Lustig RH, Martin-Chouly C, Munic Kos V, Podechard N, Roepke TA, Sargis RM, Starling A, Tomlinson CR, Touma C, Vondracek J, Vom Saal F, Blumberg B. Obesity II: Establishing causal links between chemical exposures and obesity. Biochem Pharmacol. 2022 May;199:115015. doi: 10.1016/j.bcp.2022.115015. Epub 2022 Apr 5.
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- Department of Error. Lancet. 2020 Jun 13;395(10240):1834. doi: 10.1016/S0140-6736(19)32947-2. No abstract available.
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- 20251480
- 1R43ES037592-01 (Concessão/Contrato do NIH dos EUA)
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