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NCT Number: NCT05231824

Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University Center for Weight, Eating and Lifestyle Science

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Behavioral Weight Loss Treatment

Behavioral

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

AI-optimized Behavioral Weight Loss Treatment

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Physical Activity

    Time frame: Baseline, 1-month, 6-month, and 12-month assessment

    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.

  2. Calorie intake

    Time frame: Baseline, 1-month, 6-month, and 12-month assessment

    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.

  3. Acceptability as Measured by Likert Self-report Scale

    Time frame: 6-month and 12-month assessment

    Participants will be asked to rate satisfaction with and perceived effectiveness of the program. Counselors will rate effectiveness and ease of use.

Other outcomes

  1. Self-regulation capacity

    Time frame: Baseline and 1-month assessment

    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).

  2. Autonomous motivation

    Time frame: Baseline and 1-month assessment

    Autonomous motivation will be measured by the internally consistent and valid Treatment Self-Regulation Questionnaire.

  3. Depressive symptoms

    Time frame: Baseline and 1-month assessment

    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.

  4. Binge eating

    Time frame: Baseline and 1-month assessment

    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

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Registry information

Acronym: ReLearn

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 9, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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