Clinical trial NCT05231824: Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment
Official title: Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Obesity
Weight Loss
Behavioral treatment
Artificial intelligence
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight change
timeFrame: Baseline, 1-month, 6-month, and 12-month assessment
measure: Costs
timeFrame: Baseline, 1-month, 6-month, and 12-month assessment
Secondary outcomes:
measure: Physical Activity
timeFrame: Baseline, 1-month, 6-month, and 12-month assessment
measure: Calorie intake
timeFrame: Baseline, 1-month, 6-month, and 12-month assessment
measure: Acceptability as Measured by Likert Self-report Scale
timeFrame: 6-month and 12-month assessment
Other outcomes:
measure: Self-regulation capacity
timeFrame: Baseline and 1-month assessment
measure: Autonomous motivation
timeFrame: Baseline and 1-month assessment
measure: Depressive symptoms
timeFrame: Baseline and 1-month assessment
measure: Binge eating
timeFrame: Baseline and 1-month assessment
Locations:
city: Philadelphia
country: United States
facility: Drexel University Center for Weight, Eating and Lifestyle Science
state: Pennsylvania
Study officials:
affiliation: Drexel University Center for Weight, Eating and Lifestyle Science
name: Evan M Forman, PhD
role: PRINCIPAL_INVESTIGATOR
References: