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

Effect of Continuous Wearable Biometric Monitoring on Weight Loss and Metabolic Outcomes in Adults Undergoing Obesity Treatment: A Sensor-Mediated Adaptive Randomized Controlled Trial in Bariatric and Metabolic Intervention (SMART-BMI)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 52 weeks
  • Procedures mentioned: Questionnaires, Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
  • "This study addresses a specific gap in the evidence for consumer wearable devices in obesity care."
  • "All participants are followed for 52 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether using health data from an Oura smart ring helps people lose more weight and improve blood sugar and blood pressure. It is for adults getting weight-loss surgery or starting certain weight-loss medicines at UCSD Health.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to 64 and speak English or Spanish.
  • Have obesity with a BMI of 27 or higher, or meet UCSD Health's rules for weight-loss surgery. BMI is a measure based on height and weight.
  • Be getting or planning care at UCSD Health's weight-loss clinics.
  • Plan to have sleeve or gastric bypass surgery at UCSD Health at least 30 days after agreeing to join, or plan to start a GLP-1 or GLP-1/GIP weight-loss medicine.
  • Be able to give written consent to join the study.
  • Have access to a phone that works with the Oura app: iOS 15 or newer, or Android 9 or newer.
  • Agree to follow the study's lifestyle rules and wear the ring as directed when required for your study group.
  • For part 2, agree to be placed by chance in a group with ring monitoring and coaching or coaching alone.

Who can't join

  • Cannot safely wear the ring; have an implanted heart or nerve device; or have a heart rhythm problem or heart medicine that could affect ring readings. Also excluded: unwilling to stop using another health-tracking device.
  • Have severe heart disease, end-stage lung disease, advanced kidney disease, dialysis, an organ transplant, or cancer treatment within the past 12 months.
  • Have severe slow stomach emptying, ongoing pancreas swelling, serious uncontrolled bowel inflammation, liver scarring, high pressure in the liver's blood vessels, or an uncontrolled blood-clotting problem.
  • Have a hormone or metabolism problem that makes weight loss difficult, a sleep disorder that could make ring readings unreliable, or another condition the study doctor says makes joining unsuitable.
  • For the surgery group: have had weight-loss surgery before or cannot tolerate medicine that puts you to sleep for surgery. Gastric band adjustments within the study's stated time window also rule out joining.
  • Have a severe or uncontrolled mental health condition, suicidal thoughts, unstable or untreated major depression within the past 12 months, or an alcohol or drug use disorder active within the past 12 months.
  • Are pregnant, breastfeeding, or planning pregnancy within 24 months after joining; or have an eating disorder that has not been in remission for more than 1 year.
  • Cannot fully understand consent or follow treatment directions. For the medicine group, use of GLP-1 or similar medicines within the past 6 months also rules out joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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) * Any history or current health condition that, in the PI's opinion, would make the participant ineligible or would substantially compromise the quality or interpretability of wearable-derived data

Study sites (1)

CA