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NOT YET RECRUITING

NCT07736729

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

Sponsor: Jeff Reeves

View on ClinicalTrials.gov

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

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2026-08-17

Completion Date

2031-02-28

Last Updated

2026-07-30

Healthy Volunteers

Conditions

Obesity

Interventions

BEHAVIORAL

Biometric-informed care

Participants wear a consumer-grade wearable ring continuously and receive standardized health coaching from a study-funded coach. The coach and the multidisciplinary clinical team managing the participant's obesity treatment, including the surgical team for participants undergoing bariatric surgery and/or the obesity medicine physicians managing pharmacotherapy, along with dietitians, nurse practitioners, and nursing coordinators, can view the participant's continuously collected biometric data (sleep, heart rate, and activity) through a dashboard and incorporate it into care decisions. This intervention differs from the comparator only in the care team's and coach's access to and use of the wearable biometric data. Coach contact frequency is standardized across arms.

BEHAVIORAL

Control Arm: Standard Care

Participants receive standard obesity treatment. The multidisciplinary clinical team managing the participant's obesity treatment, including the surgical team for participants undergoing bariatric surgery and/or the obesity medicine physicians managing pharmacotherapy, along with dietitians, nurse practitioners, nursing coordinators, and health coaches who manage care as usual without access to wearable biometric data. Coach and treatment team contact frequency matches the intervention arm, so the two arms differ only in the patient and the care team's access to and use of wearable biometric data.

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

Locations (1)

UTC Digestive Diseases, University of California, San Diego Health

San Diego, California, United States