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

Korábbi kezelés

• Previous bariatric procedure at any time (bariatric surgery cohort only)
• History of solid organ transplant, or currently receiving dialysis
• Inability to tolerate general anesthesia (bariatric surgery cohort only)
• Prior use of incretin-based therapy within the past 6 months (GLP-1 initiation cohort only)

Más betegség

• 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
• 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
• 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 laparoscopic gastric band with active band titration (any adjustments occurring or planned within 1 year of the start or end of the study period)
• 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
• Active diagnosed eating disorder (not in remission for more than 1 year)
• 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

Egyéb

• Any contraindication to wearing the Oura Ring per current manufacturer labeling and safety guidelines
• Severe gastroparesis
• Chronic pancreatitis
• Uncontrollable coagulopathy
• Pregnant, breastfeeding, or planning pregnancy within the study follow-up period (24 months from enrollment)
• 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

• 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