Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment

Obesity Clinical Trial

— ReLearn  

Official title:

Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231824
• Other study ID #: R01DK12564
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: June 2024
• Source: Drexel University
• Contact: Rachel Shannon, BA
• Phone: 856-425-0670
• Email: rbs77[@]drexel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: March 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

Behavioral:
• Standard Behavioral Weight Loss Treatment
Behavioral weight loss treatment is the current gold standard treatment for obesity.
• 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.

Locations

Country	Name	City	State
United States	Drexel University Center for Weight, Eating and Lifestyle Science	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Baseline and 1-month assessment
Other	Autonomous motivation	Autonomous motivation will be measured by the internally consistent and valid Treatment Self-Regulation Questionnaire.	Baseline and 1-month assessment
Other	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.	Baseline and 1-month assessment
Other	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	Baseline and 1-month assessment
Primary	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
Primary	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	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.	Baseline, 1-month, 6-month, and 12-month assessment
Secondary	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.	Baseline, 1-month, 6-month, and 12-month assessment
Secondary	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.	6-month and 12-month assessment