Elements Vital to Treat Obesity Study (NCT04708769) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Elements Vital to Treat Obesity Study
United States524 participantsStarted 2021-03-16
Plain-language summary
The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI 30-45
* Weight stable
* Own a Smartphone and be willing to install our Smartphone app
* Willing to conduct video conference calls with study staff
Exclusion Criteria:
* Enrolled in any formal weight loss program
* Taking anti-obesity medications
* Not taking medications that may cause weight gain
* Unstable medical conditions
* Diabetes requiring insulin supplementation
* Crohn's Disease
* Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP)
* Assistive devices for mobility
* Hospitalizations for a psychiatric disorder within the past 5 years
* Cardiovascular disease symptoms while performing moderate intensity exercise
* Pregnancy, trying to get pregnant, or lactating.
* Bulimia or binge eating disorder
* Reports of active suicidal ideation
* Current substance abuse or dependence besides nicotine dependence
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.