Continuous Wearable Biometric Monitoring in Adults Undergoing Obesity Treatment (SMART-BMI)

Starting soon · Not applicable

Conditions studied: Obesity

In brief

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

Key facts

Study ID: NCT07736729
Run by: Jeff Reeves
People needed: 260
Starts: 2026-08-17
Expected to finish: 2031-02-28
Last updated by the study team: 2026-07-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Any contraindication to wearing the Oura Ring per current manufacturer labeling and safety guidelines
Implanted cardiac device, pacemaker, implantable cardioverter-defibrillator, or neurostimulator
Severe heart disease (such as severe heart failure or unstable coronary artery disease) or end-stage lung disease, as determined by the site PI
Known cardiac arrhythmia, or use of any cardiac medication (such as a beta-blocker) that in the PI's opinion would interfere with the quality of Oura-derived heart rate or heart rate variability data
Severe gastroparesis
Previous bariatric procedure at any time (bariatric surgery cohort only)
Endocrine or metabolic condition that would make weight loss clinically complicated or difficult to achieve, at the discretion of the study team (such as uncontrolled hypothyroidism, chronic glucocorticoid use, or a genetic condition unresponsive to standard treatment)
Portal hypertension or cirrhosis
Chronic kidney disease Stage IV or greater, or on dialysis
Chronic pancreatitis
Significant and uncontrolled inflammatory bowel disease
Diagnosed sleep disorder that would substantially impair the validity of wearable-derived sleep measurements (such as severe untreated obstructive sleep apnea or severe insomnia)
Active cancer treatment within the past 12 months
History of solid organ transplant, or currently receiving dialysis
Inability to tolerate general anesthesia (bariatric surgery cohort only)
History of laparoscopic gastric band with active band titration (any adjustments occurring or planned within 1 year of the start or end of the study period)
Uncontrollable coagulopathy
Severe or uncontrolled psychiatric disorder (including active psychosis or bipolar disorder with an active manic episode), as determined during standard pre-surgery psychiatric screening or clinical assessment
Suicidal ideation, or unstable or untreated major depressive disorder within the past 12 months
Active alcohol or substance use disorder within the past 12 months
Pregnant, breastfeeding, or planning pregnancy within the study follow-up period (24 months from enrollment)
Active diagnosed eating disorder (not in remission for more than 1 year)
Diminished capacity to provide informed consent or to follow pre- and post-treatment instructions, as determined by the clinical team
Current use of another wearable health monitoring device (such as Apple Watch, Fitbit, or Garmin) that the participant is unwilling to stop using for the study duration
Prior use of incretin-based therapy within the past 6 months (GLP-1 initiation cohort only)

Where it is running

UTC Digestive Diseases, University of California, San Diego Health — San Diego, California, United States

Full record on ClinicalTrials.gov

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