Continuous Wearable Biometric Monitoring in Adults Undergoing Obesity Treatment (SMART-BMI)
United States260 participantsStarted 2026-08-17
Plain-language summary
The goal of this clinical trial is to learn if a smart ring that tracks health signals can help adults lose weight and improve their health during obesity treatment. The study includes adults who are having weight-loss surgery or starting weight-loss medication.
The Oura Ring tracks signals like sleep, heart rate, and activity. In this study, the care team can see this information and use it to guide each person's care.
The main questions it aims to answer are:
Do people lose more weight when their care team uses the ring's information? Does using the ring's information improve health measures like blood sugar and blood pressure?
The study has two parts. In the first part, everyone wears the ring while the study team makes sure the ring's information can be collected and used. In the second part, the study places participants into one of two groups by chance, like flipping a coin. One group's care team uses the ring's information. The other group's care team does not. Researchers will compare the two groups to see if the ring's information helps.
Participants will:
Wear the Oura Ring during the study Go to their regular clinic visits Answer survey questions about their health and quality of life
Who can participate
Age range
18 Years – 64 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:
* Age 18 years or older and under 65 years
* Diagnosis of obesity (BMI 27 kg/m² or greater), or meeting clinical criteria for bariatric surgery per standard of care at UCSD Health
* Actively receiving or planning to receive care through UCSD Health Bariatric and Metabolic Institute or Obesity Medicine clinics
* Able to provide written informed consent
* Owns or has access to a smartphone compatible with the Oura application (iOS 15 or higher, or Android 9 or higher)
* Agrees to follow the study's lifestyle considerations throughout the study
* Willing to wear the Oura Ring per manufacturer-recommended wear guidelines for the study duration (Phase 1: all participants; Phase 2: intervention arm only)
* For Phase 2: willing to be randomly assigned to either the wearable monitoring plus coaching arm or the coaching-only arm
* Bariatric Surgery Cohort: scheduled for bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) at UCSD Health within the enrollment window, with surgery planned at least 30 days after consent to allow a baseline monitoring period
* GLP-1 Initiation Cohort: planned start of incretin-based medication (GLP-1 receptor agonist or dual GLP-1/GIP agonist) as part of routine clinical care
* Ability to speak English or Spanish
Exclusion Criteria:
* Any contraindication to wearing the Oura Ring per current manufacturer labeling and safety guidelines
* Implanted cardiac device, pacemaker, implantable cardioverter-defibrillator, or neu…
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.