NCT05231824

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
336

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

3.4 years

First QC Date

January 26, 2022

Last Update Submit

August 19, 2025

Conditions

ObesityWeight Loss

Keywords

ObesityWeight LossBehavioral treatmentArtificial intelligence

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    Baseline, 1-month, 6-month, and 12-month assessment

Secondary Outcomes (3)

  • Physical Activity

    Baseline, 1-month, 6-month, and 12-month assessment

  • Calorie intake

    Baseline, 1-month, 6-month, and 12-month assessment

  • Acceptability as Measured by Likert Self-report Scale

    6-month and 12-month assessment

Other Outcomes (4)

  • Self-regulation capacity

    Baseline and 1-month assessment

  • Autonomous motivation

    Baseline and 1-month assessment

  • Depressive symptoms

    Baseline and 1-month assessment

  • +1 more other outcomes

Study Arms (2)

BWL-S

ACTIVE COMPARATOR

1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician.

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.

Behavioral: AI-optimized Behavioral Weight Loss Treatment

Interventions

Standard Behavioral Weight Loss TreatmentBEHAVIORAL

Behavioral weight loss treatment is the current gold standard treatment for obesity.

BWL-S
AI-optimized Behavioral Weight Loss TreatmentBEHAVIORAL

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.

BWL-AI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University Center for Weight, Eating and Lifestyle Science

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 37930786DERIVED

  • Forman 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.

    PMID: 36435427DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Evan M Forman, PhD

    Drexel University Center for Weight, Eating and Lifestyle Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychological and Brain Sciences

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 9, 2022

Study Start

March 22, 2022

Primary Completion

August 31, 2025

Study Completion

March 31, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)