Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment

NCT ID: NCT05231824

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-22

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BWL-S

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

Group Type ACTIVE_COMPARATOR

Standard Behavioral Weight Loss Treatment

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

AI-optimized Behavioral Weight Loss Treatment

Intervention Type BEHAVIORAL

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.

Interventions

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Standard Behavioral Weight Loss Treatment

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Drexel University

OTHER

Sponsor Role lead

Responsible Party

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Erica Schulte

Professor of Psychological and Brain Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evan M Forman, PhD

Role: PRINCIPAL_INVESTIGATOR

Drexel University Center for Weight, Eating and Lifestyle Science

Locations

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Drexel University Center for Weight, Eating and Lifestyle Science

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37930786 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36435427 (View on PubMed)

Other Identifiers

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R01DK12564

Identifier Type: -

Identifier Source: org_study_id

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