Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment (ReLearn)

September 1, 2026 updated by: elafata@ori.org, Oregon Research Institute
Project ReLearn is testing the efficacy and cost-effectiveness of an Artificial Intelligence system for optimizing weight loss coaching. Participants are randomized to a 1-year weekly gold standard behavioral weight loss remote (video) group treatment or the AI-optimized treatment, which is made up of a combination of remote group treatment, short video call and automated message. In the AI-optimized condition, the system monitors outcomes (via wireless scale, mobile phone app, and wristworn tracker) and, each week, assigns each participant the treatments they have responding to the best, within certain time constraints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Drexel University Center for Weight, Eating and Lifestyle Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals must be of overweight or obese BMI (27-50 kg/m)
  • Individuals must be adults (aged 18-70)
  • Able and willing to engage in the remote program
  • Able to engage in physical activity (defined as walking two city blocks without stopping)
  • Individuals must also provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss
  • Access and willingness to use an Apple or Android smartphone
  • Satisfactory completion of all enrollment procedures

Exclusion Criteria:

  • Medical condition (e.g., cancer, type I diabetes, psychosis, full-threshold eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
  • Currently pregnant, breastfeeding, or planning to become pregnant in the next 12 months
  • Recently began or changed the dosage of medication that can cause significant change in weight
  • History of bariatric surgery
  • Weight loss of > 5% in the previous 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BWL-S
1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician.
Behavioral: Standard Behavioral Weight Loss Treatment
Behavioral weight loss treatment is the current gold standard treatment for obesity.
Experimental: BWL-AI
1 year of remote weight loss treatment made up of a combination of (1) remote small group-based behavioral weight loss sessions, (2) 12-minute individual video calls, (2) automated text messages. An MS-level clinician will deliver the group treatment. Most video calls will be delivered by a paraprofessional coach, but some by an MS-level clinician. Each week the AI system will select one of the interventions for each participant based on which treatment the participant has responded to the best, within certain time constraints.
Behavioral: AI-optimized Behavioral Weight Loss Treatment
AI-optimized Behavioral Weight Loss Treatment will continuously vary intensity (automated text message, videoconference group, individual coaching call) and coach type (paraprofessional or MS-level expert) based on continuously-monitored participant digital data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: Baseline, 1-month, 6-month, and 12-month assessment
Weight will be measured using the Fitbit Aria Air wireless scale, which is accurate to 0.2 kg. In order to maximize accuracy, we will (1) provide instructions (e.g., place scale on flat, hard surface; weigh upon waking, without clothes, after using the bathroom), (2) require participants to confirm that they are following instructions at each assessment point, (3) use an average of 5 consecutive daily weights for each timepoint, (4) remove errant weights (e.g., >1 kg change in 1 day).
Baseline, 1-month, 6-month, and 12-month assessment
Costs
Time Frame: Baseline, 1-month, 6-month, and 12-month assessment
All time spent training counselors, participants and supervising counselors, will be tracked by the project coordinator, as will time counselors spend delivering individual and group treatment. The web portal will track counselor time on the portal, e.g., reviewing food records and texting. While the basic time commitments are pre-set by condition, several factors will vary including participant no-shows, participant drop-outs, and counselor adherence to time limits.
Baseline, 1-month, 6-month, and 12-month assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: Baseline, 1-month, 6-month, and 12-month assessment
Minutes of moderate to vigorous physical activity (MVPA) will be measured via Fitbit, a consumer-grade wrist-worn activity tracker which has superior compliance and close-to-equivalent accuracy as a research-grade accelerometer. Number of days meeting MVPA goal will be used by the AI system, with MVPA minutes as a secondary outcome.
Baseline, 1-month, 6-month, and 12-month assessment
Calorie intake
Time Frame: Baseline, 1-month, 6-month, and 12-month assessment
Seven days of calorie intake as derived from the Fitbit app's food log will be used as a secondary outcome. Participants will already be tracking their consumption using the app because data are used by both the coaches (per standard treatment) and the AI system.
Baseline, 1-month, 6-month, and 12-month assessment
Acceptability as Measured by Likert Self-report Scale
Time Frame: 6-month and 12-month assessment
Participants will be asked to rate satisfaction with and perceived effectiveness of the program. Counselors will rate effectiveness and ease of use.
6-month and 12-month assessment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-regulation capacity
Time Frame: Baseline and 1-month assessment
Self-regulation capacity will be measured directly using the Brief Self-Control Scale (which has strong retest reliability and internal consistency and predicts weight loss and dietary health).
Baseline and 1-month assessment
Autonomous motivation
Time Frame: Baseline and 1-month assessment
Autonomous motivation will be measured by the internally consistent and valid Treatment Self-Regulation Questionnaire.
Baseline and 1-month assessment
Depressive symptoms
Time Frame: Baseline and 1-month assessment
Depressive symptoms will be measured with the 20-item Center for Epidemiologic Studies Depression Scale. This self-report scale is widely used and has proven reliable across a variety of demographic groups and in both clinical and nonclinical populations.
Baseline and 1-month assessment
Binge eating
Time Frame: Baseline and 1-month assessment
Binge eating will be measured with the Binge Eating Module of the Eating Disorders Examination (EDE), which is a well-validated, reliable measure of eating disorder symptoms that differentiates between individuals with and without Binge Eating Disorder in
Baseline and 1-month assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Investigators

  • Principal Investigator: Evan M Forman, PhD, Drexel University Center for Weight, Eating and Lifestyle Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK12564 Transfer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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