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

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

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.

Sponsors & Collaborators

• Oura health oy

  collaborator UNKNOWN

• Jeff Reeves

  lead OTHER

Principal Investigators

• James J Reeves, MD · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-17

Primary Completion

2030-12-30

Completion

2031-02-28

Countries

• United States

Study Locations