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Behavioural Intervention
AI-Optimized Weight Loss Treatment for Obesity (ReLearn Trial)
N/A
Recruiting
Led By Evan M Forman, PhD
Research Sponsored by Drexel University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals must be adults (aged 18-70)
Access and willingness to use an Apple or Android smartphone
Must not have
History of bariatric surgery
Weight loss of > 5% in the previous 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-month, 6-month, and 12-month assessment
Awards & highlights
Summary
This trial is testing a weight-loss AI system to see if it's more effective and cheaper than weekly gold-standard behavioral weight-loss treatment.
Who is the study for?
Adults aged 18-70 with a BMI of 27-50 kg/m², able to walk two city blocks and engage in remote weight loss programs using a smartphone. Excludes those with certain medical conditions, recent significant weight loss, or changes in medications affecting weight.Check my eligibility
What is being tested?
Project ReLearn is comparing standard behavioral treatment for weight loss against an AI-optimized version that adapts weekly based on participant responses using mobile and wearable tech over one year.See study design
What are the potential side effects?
Since this trial involves non-medical interventions focused on behavior change and monitoring via technology, there are no direct side effects like you'd expect from medication; however, participants may experience stress or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
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I can and will use a smartphone.
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My BMI is between 27 and 50, indicating I am overweight or obese.
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I can walk two city blocks without needing to stop.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had weight loss surgery in the past.
Select...
I have lost more than 5% of my weight in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-month, 6-month, and 12-month assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-month, 6-month, and 12-month assessment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Costs
Weight change
Secondary outcome measures
Acceptability as Measured by Likert Self-report Scale
Calorie intake
Physical Activity
Other outcome measures
Autonomous motivation
Binge eating
Depressive symptoms
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BWL-AIExperimental Treatment1 Intervention
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.
Group II: BWL-SActive Control1 Intervention
1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician.
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Who is running the clinical trial?
Drexel UniversityLead Sponsor
151 Previous Clinical Trials
47,738 Total Patients Enrolled
30 Trials studying Obesity
6,281 Patients Enrolled for Obesity
Evan M Forman, PhDPrincipal InvestigatorDrexel University Center for Weight, Eating and Lifestyle Science
1 Previous Clinical Trials
285 Total Patients Enrolled
1 Trials studying Obesity
285 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I recently started or changed the dose of a medication that may significantly affect my weight.I am between 18 and 70 years old.I have had weight loss surgery in the past.I can and will use a smartphone.I am willing and able to participate in a remote program.I have lost more than 5% of my weight in the last 3 months.My BMI is between 27 and 50, indicating I am overweight or obese.I can walk two city blocks without needing to stop.I have a condition that could risk my health during the study or affect my weight.
Research Study Groups:
This trial has the following groups:- Group 1: BWL-S
- Group 2: BWL-AI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05231824 — N/A
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