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Clinical Trials/NCT05231824
NCT05231824
Active, not recruiting
Not Applicable

Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment

Drexel University1 site in 1 country336 target enrollmentMarch 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Drexel University
Enrollment
336
Locations
1
Primary Endpoint
Costs
Status
Active, not recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 22, 2022
End Date
March 31, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erica Schulte

Professor of Psychological and Brain Sciences

Drexel University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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).

Secondary Outcomes

  • 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)
  • Physical Activity(Baseline, 1-month, 6-month, and 12-month assessment)

Study Sites (1)

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