Lifestyle Interventions for Obesity
(LiveWell Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores methods to help individuals with obesity or overweight reduce their weight and exposure to endocrine-disrupting chemicals (EDCs). One group will use a digital weight loss program, while the other will focus on reducing EDC exposure through lifestyle changes. The researchers aim to determine which approach more effectively reduces weight and EDC levels. Participants should have a BMI over 25, no certain chronic diseases, and access to a smartphone or computer. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new strategies for managing weight and EDC exposure.
Do I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on GLP-1 medications, you cannot participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lifestyle changes, like those tested in this study, can aid in weight loss and health improvement. Studies have found that short-term programs focusing on exercise and healthy eating can lead to weight loss in adults with obesity. For instance, a commercial weight loss program reported that half of its participants lost a significant amount of weight after one year.
Regarding the safety of reducing exposure to endocrine-disrupting chemicals (EDCs), research is ongoing about their effects. These chemicals, found in everyday products, have been linked to health issues such as metabolism problems and weight gain. This trial aims to reduce exposure to these chemicals, which is not known to be harmful.
Since the trial is not in a specific clinical phase, detailed safety data might be limited. However, because the trial focuses on lifestyle changes rather than new drugs, the risk of side effects is likely lower. Participants will use a digital program and educational materials, which are generally safe and well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about the Lifestyle Interventions for Obesity trial because it explores two innovative approaches to weight management. The Weight Loss Group uses a digital weight loss application, which is a modern, tech-driven method to support people in their weight loss journey. This differs from traditional methods like diet and exercise plans by integrating technology for personalized tracking and feedback. The EDC Reduction Intervention Group focuses on reducing exposure to endocrine-disrupting chemicals, which is a novel angle that considers environmental factors affecting obesity. By addressing these often-overlooked contributors to obesity, the trial could uncover new, holistic strategies for effective weight management.
What evidence suggests that this trial's treatments could be effective for obesity?
This trial will compare two approaches for managing weight: a Weight Loss Program and an EDC Reduction Intervention. Studies have shown that short-term programs combining diet and exercise can help people who are overweight or have obesity lose weight. In one study, participants lost an average of 8.6% of their starting weight in a year. Participants in the Weight Loss Group will use a weight loss application for 12 weeks.
Research also suggests that avoiding certain chemicals, known as endocrine-disrupting chemicals (EDCs), can aid in weight management. EDCs interfere with hormones and have been linked to weight gain and other health problems. Reducing exposure to these chemicals has shown promise in improving weight outcomes. Participants in the EDC Reduction Intervention Group will focus on reducing their exposure to these chemicals through lifestyle audits and educational materials. These findings suggest that both lifestyle changes and reducing EDC exposure can effectively manage weight.14567Who Is on the Research Team?
Johanna R Rochester, PhD
Principal Investigator
Million Marker Wellness
Are You a Good Fit for This Trial?
This trial is for adults with a BMI over 25 (overweight or obese) who are not pregnant, breastfeeding, or have major health issues like diabetes, heart, kidney, liver, lung disease, or cancer. Participants must not smoke or be in another weight loss program and need access to a smartphone or computer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline surveys and receive test kits for urine and blood samples
Intervention
Participants engage in either a 12-week EDC reduction program or a digital weight loss program
Post-Intervention Assessment
Participants submit post-intervention samples and complete surveys
Follow-up
Participants are monitored for changes in EDC metabolites and weight-related health literacy
What Are the Treatments Tested in This Trial?
Interventions
- Weight Loss and EDC Reduction Program
Trial Overview
The study compares two 12-week programs: one focuses on reducing exposure to endocrine disrupting chemicals (EDCs) through education and testing; the other uses a digital weight loss app. Both aim to help participants lose weight and lower EDC levels.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Million Marker Wellness, Inc.
Lead Sponsor
Mayo Clinic
Collaborator
National Institute of Environmental Health Sciences (NIEHS)
Collaborator
Citations
Endocrine disrupting chemicals and obesity prevention - PMC
A total of 10 systematic reviews and meta-analysis studies met our inclusion criteria on more prominent EDCs focusing mainly on bisphenols, ...
Lifestyle Interventions to Lose Weight and Reduce EDC ...
The goal of this study is to examine the relationship in individuals with overweight/obesity and endocrine disrupting chemical (EDC) ...
Understanding the role of endocrine disrupting chemicals ...
Obesogens are endocrine-disrupting chemicals (EDCs) that can alter lipid homeostasis, promote adipogenesis, and disrupt metabolic regulation.
A review of recommendations for obesity prevention policies
Outcomes. Recommended policies, strategies and actions to reduce adiposity or prevent excess adiposity, in relation to EDC exposure. LOBSTEIN ...
Reducing Exposures to Endocrine Disruptors (REED) study, a ...
A personalized at-home intervention program to reduce exposure to endocrine disrupting chemicals among a child-bearing age cohort.
Weight Loss Patterns and Outcomes Over 12 Months on a ...
This commercial weight loss program was shown to be effective, with 1 in 2 members achieving clinically significant results after 1 year.
Clinical epidemiology studies on potential effects of ...
Obesity as determined by BMI is a confounder in clinical evaluations of the effects of endocrine disrupting chemicals (EDCs).
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.