An interventional study of Standard Behavioral Weight Loss Treatment and AI-optimized Behavioral Weight Loss Treatment in Obesity and Weight Loss, sponsored by Oregon Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Oregon Research Institute · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 301 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Oregon Research Institute is the lead sponsor of 70 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician.
Behavioral: Standard Behavioral Weight Loss Treatment
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
Behavioral weight loss treatment is the current gold standard treatment for obesity.
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.
Weight change
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).
Time frame: Baseline, 1-month, 6-month, and 12-month assessment
Costs
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.
Time frame: Baseline, 1-month, 6-month, and 12-month assessment
Physical Activity
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.
Time frame: Baseline, 1-month, 6-month, and 12-month assessment
Calorie intake
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.
Time frame: Baseline, 1-month, 6-month, and 12-month assessment
Acceptability as Measured by Likert Self-report Scale
Participants will be asked to rate satisfaction with and perceived effectiveness of the program. Counselors will rate effectiveness and ease of use.
Time frame: 6-month and 12-month assessment
Self-regulation capacity
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).
Time frame: Baseline and 1-month assessment
Autonomous motivation
Autonomous motivation will be measured by the internally consistent and valid Treatment Self-Regulation Questionnaire.
Time frame: Baseline and 1-month assessment
Depressive symptoms
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.
Time frame: Baseline and 1-month assessment
Binge eating
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
Time frame: Baseline and 1-month assessment
Plan to share: No
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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