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

NCT07736729 | Not Yet Recruiting DMC

• 2 other identifiers: 814666#814666
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Obesity

Keywords

wearable device; continuous biometric monitoring; obesity treatment; bariatric surgery; glp-1 agonist

Outcome Measures

Primary Outcomes (1)

• Percent Total Body Weight Loss (%TBWL)

  %TBWL = \[(baseline weight - weight at 52 weeks) / baseline weight\] × 100. Weight in kg abstracted from the EHR

  52 weeks

Secondary Outcomes (5)

• HbA1c

  52 weeks

• Blood Pressure

  52 weeks

• Lipid Profile

  52 weeks

• Health-Related Quality of Life (PROMIS-29 v2.1)

  52 weeks

• Treatment Persistence (GLP-1 stratum)

  52 weeks

Other Outcomes (4)

• Exploratory Comparison of Phase 1 Outcomes to Historical EHR-Based Controls

  52 weeks

• Wearable Adherence and Data Completeness (Phase 1 feasibility; Phase 2 process measure)

  52 weeks

• Phase 1 Outcome Variability Estimate (%TBWL standard deviation)

  52 weeks

Study Arms (2)

Intervention Arm: Biometric-Informed Care

EXPERIMENTAL

Participants wear the Oura Ring (Generation 4) continuously while receiving standard of care medical and/or surgical treatment for obesity and receive standardized health coaching from a study-funded coach. The care team and health coach can view the participant's biometric data (including sleep, heart rate, and activity) through a dashboard and incorporates this information into coaching and care decisions. Participants are followed for 52 weeks.

Behavioral: Biometric-informed care

Control Arm: Standard Care

ACTIVE COMPARATOR

Participants receive standardized care for the treatment of obesity including surgical or medical obesity management and health coaching from a study-funded coach who delivers a behavioral curriculum without access to any wearable biometric data. Care team contact frequency matches the intervention arm so that the two arms differ only in the patient and care team's access to biometric data. Participants are followed for 52 weeks.

Behavioral: Control Arm: Standard Care

Interventions

Biometric-informed care BEHAVIORAL

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.

Intervention Arm: Biometric-Informed Care

Control Arm: Standard Care BEHAVIORAL

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.

Control Arm: Standard Care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Jeff Reeves: lead
• Oura health oy: collaborator

Study Sites (1)

UTC Digestive Diseases, University of California, San Diego Health

San Diego, California, 92122, United States

Location

Related Publications (10)

• Hays RD, Spritzer KL, Schalet BD, Cella D. PROMIS(R)-29 v2.0 profile physical and mental health summary scores. Qual Life Res. 2018 Jul;27(7):1885-1891. doi: 10.1007/s11136-018-1842-3. Epub 2018 Mar 22.

  PMID: 29569016 BACKGROUND

• Tang MSS, Moore K, McGavigan A, Clark RA, Ganesan AN. Effectiveness of Wearable Trackers on Physical Activity in Healthy Adults: Systematic Review and Meta-Analysis of Randomized Controlled Trials. JMIR Mhealth Uhealth. 2020 Jul 22;8(7):e15576. doi: 10.2196/15576.

  PMID: 32706685 BACKGROUND

• Longhini J, Marzaro C, Bargeri S, Palese A, Dell'Isola A, Turolla A, Pillastrini P, Battista S, Castellini G, Cook C, Gianola S, Rossettini G. Wearable Devices to Improve Physical Activity and Reduce Sedentary Behaviour: An Umbrella Review. Sports Med Open. 2024 Jan 14;10(1):9. doi: 10.1186/s40798-024-00678-9.

  PMID: 38219269 BACKGROUND

• Wong SH, Tan ZYA, Cheng LJ, Lau ST. Wearable technology-delivered lifestyle intervention amongst adults with overweight and obese: A systematic review and meta-regression. Int J Nurs Stud. 2022 Mar;127:104163. doi: 10.1016/j.ijnurstu.2021.104163. Epub 2021 Dec 18.

  PMID: 35092872 BACKGROUND

• Li R, Li Y, Wang L, Li L, Fu C, Hu D, Wei Q. Wearable Activity Tracker-Based Interventions for Physical Activity, Body Composition, and Physical Function Among Community-Dwelling Older Adults: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Med Internet Res. 2025 Apr 3;27:e59507. doi: 10.2196/59507.

  PMID: 40179387 BACKGROUND

• Struven A, Holzapfel C, Stremmel C, Brunner S. Obesity, Nutrition and Heart Rate Variability. Int J Mol Sci. 2021 Apr 19;22(8):4215. doi: 10.3390/ijms22084215.

  PMID: 33921697 BACKGROUND

• Arterburn DE, Telem DA, Kushner RF, Courcoulas AP. Benefits and Risks of Bariatric Surgery in Adults: A Review. JAMA. 2020 Sep 1;324(9):879-887. doi: 10.1001/jama.2020.12567.

  PMID: 32870301 BACKGROUND

• Holst JJ. GLP-1 physiology in obesity and development of incretin-based drugs for chronic weight management. Nat Metab. 2024 Oct;6(10):1866-1885. doi: 10.1038/s42255-024-01113-9. Epub 2024 Aug 19.

  PMID: 39160334 BACKGROUND

• Hodkinson A, Kontopantelis E, Adeniji C, van Marwijk H, McMillian B, Bower P, Panagioti M. Interventions Using Wearable Physical Activity Trackers Among Adults With Cardiometabolic Conditions: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Jul 1;4(7):e2116382. doi: 10.1001/jamanetworkopen.2021.16382.

  PMID: 34283229 BACKGROUND

• Jakicic JM, Davis KK, Rogers RJ, King WC, Marcus MD, Helsel D, Rickman AD, Wahed AS, Belle SH. Effect of Wearable Technology Combined With a Lifestyle Intervention on Long-term Weight Loss: The IDEA Randomized Clinical Trial. JAMA. 2016 Sep 20;316(11):1161-1171. doi: 10.1001/jama.2016.12858.

  PMID: 27654602 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James J Reeves, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James J Reeves, MD

CONTACT

858-657-8860; jreeves@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Division of Minimally Invasive Surgery, Department of Surgery, Division of Biomedical Informatics, Department of Medicine

Model Details: This is a two-phase adaptive study registered as a single record. Phase 1 is a single-arm observational feasibility phase in which all participants receive the wearable device and are followed during routine care; it validates the data pipeline and informs Phase 2 sample-size estimation. Phase 2 is a parallel-assignment randomized controlled trial with 1:1 allocation to two arms, activated after an independent Data Safety Monitoring Board reviews Phase 1 feasibility. The Parallel model selected above reflects the Phase 2 randomized comparison.

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): February 28, 2031
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data and supporting documents will become available beginning 12 months after publication of the primary results and will remain available for 5 years thereafter. Requests received after this period may be considered at the discretion of the Principal Investigator and the institution.
• Access Criteria: Requests for de-identified data are reviewed by the Principal Investigator and the University of California, San Diego. Data may be shared with researchers whose proposed analyses are consistent with the original participant consent and are approved by the UCSD IRB, under an executed data use agreement. Available data are limited to the de-identified individual participant dataset underlying published results, with an accompanying data dictionary. Sharing of wearable-derived biometric data is additionally subject to the terms of the study's agreement with the device sponsor. Only fully de-identified data are released; no direct identifiers or the linkage key are shared. Requests may be directed to the Principal Investigator.

Locations

US (1)