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

Part of paid clinical trials in San Diego, California.

Sponsor: Jeff Reeves
Study ID: NCT07736729
Status: Not Yet Recruiting

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Conditions

Obesity

Eligibility Criteria

Sex: ALL
Age: 18 Years - 64 Years
Healthy Volunteers: Not accepted

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.
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.

Study Details

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

Key Dates

First listed: Jul 30, 2026
Start date: Aug 17, 2026
Status verified: Jul 2026
Primary completion: Dec 30, 2030
Completion: Feb 28, 2031

Study Design

Enrollment: 260 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Intervention Arm: Biometric-Informed Care
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.
Active Comparator: Control Arm: Standard Care
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.