ObesitySMART-BMINCT07736729
Continuous Wearable Biometric Monitoring in Adults Undergoing Obesity Treatment (SMART-BMI)
A study testing Biometric-informed care in people with Obesity, run by Jeff Reeves at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- Biometric-informed care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to 28 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UTC Digestive Diseases, University of California, San Diego Health
San Diego, California, 92122
Clinic Manager, MSN, RN, 858-657-8866, cmariduena@health.ucsd.edu
About this study
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)
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.
Read more
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
Read the detailed description
This study addresses a specific gap in the evidence for consumer wearable devices in obesity care. Prior trials that supplied wearable devices without integrating the resulting data into clinical decision-making have generally not improved weight outcomes. This trial is therefore designed to test not the device in isolation, but whether care teams acting on continuous biometric data achieve better outcomes than standard care.
The trial uses a two-phase adaptive design at a single academic medical center. Two treatment cohorts are enrolled in parallel throughout: adults undergoing metabolic and bariatric surgery, and adults initiating GLP-1 receptor agonist therapy. All participants are followed for 52 weeks.
Phase 1 is a single-arm observational feasibility phase. Every participant receives an Oura Ring, and the existing clinical team (dietitians, nurse practitioners, physicians, and coordinators) can view the biometric data through a dashboard during routine care. No dedicated coach and no additional study visits are added. Phase 1 validates the end-to-end data pipeline, characterizes device wear adherence and data completeness, and estimates the variability of candidate outcomes to inform Phase 2 sizing. As a pre-specified exploratory analysis, observed Phase 1 outcomes are compared against historical electronic health record-based controls within each treatment cohort; this comparison is descriptive and hypothesis-generating rather than a formal test of efficacy.
Phase 1 data will be reviewed for feasibility, safety, and outcomes, including the exploratory comparison against historical controls, before Phase 2 is activated. Phase 2 proceeds only if Phase 1 demonstrates adequate feasibility and a directional signal that biometric-informed care may improve outcomes; absent any such signal relative to historical controls, Phase 2 will not be activated. Phase 1 results are analyzed and reported regardless of whether Phase 2 proceeds.
Phase 2 is a randomized controlled trial with 1:1 parallel allocation. Phase 2 will also have a health coach-in-both-arms design: every Phase 2 participant receives a study-funded health coach. In the intervention arm, the care team can view the participant's Oura dashboard and incorporates the biometric data into management and coaching. In the control arm, the coach delivers a standardized behavioral curriculum without access to any wearable data. Because both arms receive equivalent coach contact, the design isolates the specific contribution of the biometric information rather than the added attention of a coach, removing attention bias as an explanation for any observed difference.
The study is open label, as participants and coaches are necessarily aware of arm assignment. The primary outcome is drawn objectively from electronic health record data, which limits the influence of unmasked assessment.
Sample size follows an adaptive approach. The maximum enrollment reflects an adaptive upper bound, and Phase 1 estimates allow re-estimation of the Phase 2 sample size at the interim review.
The primary analysis follows a modified intention-to-treat approach, applying a pre-specified biometric data-quality threshold symmetrically across both arms. Between-arm comparison of the primary continuous outcome uses analysis of covariance adjusting for the baseline value.
The wearable data are generated by a commercially available consumer device used consistent with its general wellness purpose; no investigational device exemption applies. The sponsor supplies devices and device-use guidance and reviews manuscripts within a pre-specified window, but holds no authority over data analysis, interpretation, or the decision to publish. The principal investigator retains scientific and publication independence.
- Conditions
- Obesity
- Being tested
- Biometric-informed care, Control Arm: Standard Care
- Keywords
- wearable device, continuous biometric monitoring, obesity treatment, bariatric surgery, glp-1 agonist
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biometric-informed careBehavioural
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.
Control Arm: Standard CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control Arm: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Total Body Weight Loss (%TBWL)
%TBWL = [(baseline weight - weight at 52 weeks) / baseline weight] × 100. Weight in kg abstracted from the EHR
Measured: 52 weeks
Secondary outcomes (5)
HbA1c
Change from baseline in glycated hemoglobin (HbA1c), abstracted from routine care EHR data
Measured: 52 weeks
Blood Pressure
Change from baseline in systolic and diastolic blood pressure.
Measured: 52 weeks
Lipid Profile
Change from baseline in LDL, HDL, and triglycerides.
Measured: 52 weeks
Health-Related Quality of Life (PROMIS-29 v2.1)
Change from baseline in PROMIS-29 v2.1 domain T-scores
Measured: 52 weeks
Treatment Persistence (GLP-1 stratum)
Proportion of GLP-1 cohort participants remaining on index therapy.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start17 Aug 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeff Reeves
- Sponsor type
- University, hospital or other
- Collaborators
- Oura health oy
- Responsible party
- Sponsor-investigator, Jeff Reeves, University of California, San Diego
- Investigators
- James J Reeves, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736729
- Sponsor's protocol ID
- 814666
- Other IDs
- #814666
- Acronym
- SMART-BMI
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications, after de-identification, along with a data dictionary defining each field.
Publications
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.
PubMed 29569016Tang 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.
PubMed 32706685Longhini 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.
PubMed 38219269Wong 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.
PubMed 35092872Li 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.
PubMed 40179387Struven 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.
PubMed 33921697Arterburn 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.
PubMed 32870301Holst 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.
PubMed 39160334Hodkinson 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.
PubMed 34283229Jakicic 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.
PubMed 27654602
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07736729
- Acronym / sponsor ID
- SMART-BMI / 814666
- Conditions
- Obesity
- Keywords
- wearable device, continuous biometric monitoring, obesity treatment, bariatric surgery, glp-1 agonist
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Jeff ReevesUniversity, hospital or other
- Collaborators
- Oura health oy
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study addresses a specific gap in the evidence for consumer wearable devices in obesity care. Prior trials that supplied wearable devices without integrating the resulting data into clinical decision-making have generally not improved weight outcomes. This trial is therefore designed to test not the device in isolation, but whether care teams acting on continuous biometric data achieve better outcomes than standard care.
The trial uses a two-phase adaptive design at a single academic medical center. Two treatment cohorts are enrolled in parallel throughout: adults undergoing metabolic and bariatric surgery, and adults initiating GLP-1 receptor agonist therapy. All participants are followed for 52 weeks.
Phase 1 is a single-arm observational feasibility phase. Every participant receives an Oura Ring, and the existing clinical team (dietitians, nurse practitioners, physicians, and coordinators) can view the biometric data through a dashboard during routine care. No dedicated coach and no additional study visits are added. Phase 1 validates the end-to-end data pipeline, characterizes device wear adherence and data completeness, and estimates the variability of candidate outcomes to inform Phase 2 sizing. As a pre-specified exploratory analysis, observed Phase 1 outcomes are compared against historical electronic health record-based controls within each treatment cohort; this comparison is descriptive and hypothesis-generating rather than a formal test of efficacy.
Phase 1 data will be reviewed for feasibility, safety, and outcomes, including the exploratory comparison against historical controls, before Phase 2 is activated. Phase 2 proceeds only if Phase 1 demonstrates adequate feasibility and a directional signal that biometric-informed care may improve outcomes; absent any such signal relative to historical controls, Phase 2 will not be activated. Phase 1 results are analyzed and reported regardless of whether Phase 2 proceeds.
Phase 2 is a randomized controlled trial with 1:1 parallel allocation. Phase 2 will also have a health coach-in-both-arms design: every Phase 2 participant receives a study-funded health coach. In the intervention arm, the care team can view the participant's Oura dashboard and incorporates the biometric data into management and coaching. In the control arm, the coach delivers a standardized behavioral curriculum without access to any wearable data. Because both arms receive equivalent coach contact, the design isolates the specific contribution of the biometric information rather than the added attention of a coach, removing attention bias as an explanation for any observed difference.
The study is open label, as participants and coaches are necessarily aware of arm assignment. The primary outcome is drawn objectively from electronic health record data, which limits the influence of unmasked assessment.
Sample size follows an adaptive approach. The maximum enrollment reflects an adaptive upper bound, and Phase 1 estimates allow re-estimation of the Phase 2 sample size at the interim review.
The primary analysis follows a modified intention-to-treat approach, applying a pre-specified biometric data-quality threshold symmetrically across both arms. Between-arm comparison of the primary continuous outcome uses analysis of covariance adjusting for the baseline value.
The wearable data are generated by a commercially available consumer device used consistent with its general wellness purpose; no investigational device exemption applies. The sponsor supplies devices and device-use guidance and reviews manuscripts within a pre-specified window, but holds no authority over data analysis, interpretation, or the decision to publish. The principal investigator retains scientific and publication independence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: Biometric-Informed Care | Experimental | Behavioral: Biometric-informed careParticipants 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. |
| Control Arm: Standard Care | Active comparator | Behavioral: Control Arm: Standard CareParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biometric-informed careParticipants 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. | Behavioural | Intervention Arm: Biometric-Informed Care |
| Control Arm: Standard CareParticipants 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. | Behavioural | Control Arm: Standard Care |
Primary outcome
Percent Total Body Weight Loss (%TBWL)
Time frame: 52 weeks
%TBWL = [(baseline weight - weight at 52 weeks) / baseline weight] × 100. Weight in kg abstracted from the EHR
5 secondary outcomes
HbA1c
Time frame: 52 weeks
Blood Pressure
Time frame: 52 weeks
Lipid Profile
Time frame: 52 weeks
Health-Related Quality of Life (PROMIS-29 v2.1)
Time frame: 52 weeks
Treatment Persistence (GLP-1 stratum)
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 29569016Hays 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.
- Background: PubMed 32706685Tang 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.
- Background: PubMed 38219269Longhini 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.
- Background: PubMed 35092872Wong 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.
- Background: PubMed 40179387Li 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.
- Background: PubMed 33921697Struven 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.
- Background: PubMed 32870301Arterburn 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.
- Background: PubMed 39160334Holst 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.
- Background: PubMed 34283229Hodkinson 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.
- Background: PubMed 27654602Jakicic 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications, after de-identification, along with a data dictionary defining each field.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James J Reeves, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biometric-informed care in people with Obesity, run by Jeff Reeves at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James J Reeves, MD (858-657-8860, jreeves@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Total Body Weight Loss (%TBWL) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07736729, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.