ObesityReLearnNCT05231824
Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment
A study testing Standard Behavioral Weight Loss Treatment and AI-optimized Behavioral Weight Loss Treatment in people with Obesity and Weight Loss, run by Oregon Research Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Standard Behavioral Weight Loss Treatment and AI-optimized Behavioral Weight Loss Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University Center for Weight, Eating and Lifestyle Science
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Obesity, Weight Loss
- Being tested
- Standard Behavioral Weight Loss Treatment, AI-optimized Behavioral Weight Loss Treatment
- Keywords
- Obesity, Weight Loss, Behavioral treatment, Artificial intelligence
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Behavioral Weight Loss TreatmentBehavioural
Behavioral weight loss treatment is the current gold standard treatment for obesity.
AI-optimized Behavioral Weight Loss TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BWL-S | Active comparator | 1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician. Receives: Behavioral: Standard Behavioral Weight Loss Treatment |
| BWL-AI | Experimental | 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. Receives: Behavioral: AI-optimized Behavioral Weight Loss Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline, 1-month, 6-month, and 12-month assessment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6-month and 12-month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start22 Mar 2022
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, elafata@ori.org, Oregon Research Institute
- Investigators
- Evan M Forman, PhD, Principal investigator, Drexel University Center for Weight, Eating and Lifestyle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231824
- Sponsor's protocol ID
- R01DK12564 Transfer
- Acronym
- ReLearn
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berry M, Taylor L, Huang Z, Chwyl C, Kerrigan S, Forman E. Automated Messaging Delivered Alongside Behavioral Treatment for Weight Loss: Qualitative Study. JMIR Form Res. 2023 Nov 6;7:e50872. doi: 10.2196/50872.
PubMed 37930786Forman EM, Berry MP, Butryn ML, Hagerman CJ, Huang Z, Juarascio AS, LaFata EM, Ontanon S, Tilford JM, Zhang F. Using artificial intelligence to optimize delivery of weight loss treatment: Protocol for an efficacy and cost-effectiveness trial. Contemp Clin Trials. 2023 Jan;124:107029. doi: 10.1016/j.cct.2022.107029. Epub 2022 Nov 23.
PubMed 36435427
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT05231824
- Acronym / sponsor ID
- ReLearn / R01DK12564 Transfer
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Weight Loss, Behavioral treatment, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 9 Feb 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BWL-S | Active comparator | Behavioral: Standard Behavioral Weight Loss Treatment1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician. |
| BWL-AI | Experimental | Behavioral: AI-optimized Behavioral Weight Loss Treatment1 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Standard Behavioral Weight Loss TreatmentBehavioral weight loss treatment is the current gold standard treatment for obesity. | Behavioural | BWL-S |
| AI-optimized Behavioral Weight Loss TreatmentAI-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. | Behavioural | BWL-AI |
Primary outcome
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).
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.
3 secondary outcomes
Physical Activity
Time frame: Baseline, 1-month, 6-month, and 12-month assessment
Calorie intake
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Derived from this study: PubMed 37930786Berry M, Taylor L, Huang Z, Chwyl C, Kerrigan S, Forman E. Automated Messaging Delivered Alongside Behavioral Treatment for Weight Loss: Qualitative Study. JMIR Form Res. 2023 Nov 6;7:e50872. doi: 10.2196/50872.
- Derived from this study: PubMed 36435427Forman EM, Berry MP, Butryn ML, Hagerman CJ, Huang Z, Juarascio AS, LaFata EM, Ontanon S, Tilford JM, Zhang F. Using artificial intelligence to optimize delivery of weight loss treatment: Protocol for an efficacy and cost-effectiveness trial. Contemp Clin Trials. 2023 Jan;124:107029. doi: 10.1016/j.cct.2022.107029. Epub 2022 Nov 23.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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. This study is not recruiting at the moment.
Evan M Forman, PhD principal investigator
Drexel University Center for Weight, Eating and Lifestyle Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Behavioral Weight Loss Treatment and AI-optimized Behavioral Weight Loss Treatment in people with Obesity and Weight Loss, run by Oregon Research Institute 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 4 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: Baseline, 1-month, 6-month, and 12-month assessment). The study lists 2 primary outcomes in all. 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 NCT05231824, which also lists 2 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 4 Sep 2026.