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

Drexel University

Status: Active, not recruiting

Conditions: Weight Loss; Obesity

Treatments: Behavioral: Standard Behavioral Weight Loss Treatment; Behavioral: AI-optimized Behavioral Weight Loss Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05231824

R01DK12564

Details and patient eligibility

About

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.

Enrollment: 336 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

336 participants in 2 patient groups

BWL-S

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Behavioral Weight Loss Treatment

BWL-AI

Experimental group

Description:

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.

Treatment:

Behavioral: AI-optimized Behavioral Weight Loss Treatment