AI-Optimized Weight Loss Treatment for Obesity

(ReLearn Trial)

Overseen By Rachel Shannon, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Cancer, Type I diabetes, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and cost-efficiency of an AI system for guiding weight loss. Participants join one of two groups: a traditional group with remote support using the Standard Behavioral Weight Loss Treatment, or an AI-driven group that employs technology like apps and trackers to tailor weekly advice through the AI-optimized Behavioral Weight Loss Treatment. The researchers seek individuals who are overweight, can walk two city blocks without stopping, and are comfortable using a smartphone. Participants should be open to remote coaching and prepared for their doctor's involvement if needed. As an unphased trial, this study offers a unique opportunity to contribute to innovative research in weight loss technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you recently started or changed the dosage of a medication that affects weight, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AI-based weight loss programs are generally safe for people. Studies have found that these AI coaching tools effectively manage obesity and related health issues. Importantly, no major negative effects have been widely reported, suggesting that the treatment is well-tolerated.

AI creates personalized weight loss plans by analyzing data from devices like scales and fitness trackers, then adjusts the program to better fit each person. This customization can lead to better results without extra risk. Although the treatment uses technology, it primarily focuses on safe behavioral changes.

The AI system complements traditional weight loss methods, which are already known to be safe and effective. Combining these approaches can improve results without compromising safety. Overall, this method appears to be a promising and safe option for those looking to manage their weight with the help of technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard behavioral weight loss treatments that rely solely on group-based sessions with a clinician, the AI-optimized weight loss treatment combines these sessions with personalized interventions. Each week, an AI system tailors the treatment by selecting the best intervention for each participant based on their previous responses, which can include individual video calls or automated text messages. This personalized approach is what excites researchers, as it offers the potential for more effective and timely weight loss by adapting to each person's unique needs and progress.

What evidence suggests that this trial's treatments could be effective for weight loss?

In this trial, participants will receive either an AI-optimized Behavioral Weight Loss Treatment or a Standard Behavioral Weight Loss Treatment. Previous studies have shown that AI-optimized weight loss treatments can help people lose weight, improve body shape, and reduce hunger compared to traditional methods. The AI system tracks progress and adjusts weekly plans based on what works best for each participant. This personalized approach aims to achieve similar or better weight loss results than standard treatments, potentially at a lower cost. Overall, the AI-optimized method offers a promising new option for managing obesity. ^{3 4 6 7 8}

Who Is on the Research Team?

Evan M Forman, PhD

Principal Investigator

Drexel University Center for Weight, Eating and Lifestyle Science

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I can and will use a smartphone.

I am willing and able to participate in a remote program.

Exclusion Criteria

I recently started or changed the dose of a medication that may significantly affect my weight.

I have had weight loss surgery in the past.

I have lost more than 5% of my weight in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 1-year weekly gold standard behavioral weight loss remote group treatment or an AI-optimized treatment

52 weeks

Weekly remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AI-optimized Behavioral Weight Loss Treatment
• Standard Behavioral Weight Loss Treatment

Trial Overview

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.

How Is the Trial Designed?

Group I: BWL-AI Experimental Treatment 1 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-S Active Control 1 Intervention

1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Published Research Related to This Trial

A study involving 159 adults with overweight or obesity aims to optimize a smartphone-based intervention that delivers timely support to prevent dietary lapses during behavioral obesity treatment over a 6-month period.

Participants will receive tailored interventions based on their risk of dietary lapses, allowing for a more personalized approach to maintaining adherence to diet, with the goal of improving weight loss outcomes in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial. Goldstein, SP., Zhang, F., Klasnja, P., et al.[2022]

In a study involving 468 adults with obesity, participants who switched to portion-controlled meals (PCM) after being identified as suboptimal responders to standard behavioral weight loss treatment (SBT) lost more weight at 6 months compared to those who switched to acceptance-based treatment (ABT), although the difference was not statistically significant.

Identifying suboptimal responders as early as Session 3 of treatment led to greater weight loss in those switched to PCM compared to those identified later, suggesting that early intervention may enhance the effectiveness of weight loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. Sherwood, NE., Crain, AL., Seburg, EM., et al.[2022]

A new study will evaluate whether a 12-month weight loss program using reinforcement learning (AI) can achieve similar weight loss results as traditional behavioral weight loss methods, but at a lower cost, involving 336 adults with overweight or obesity.

Preliminary results showed that participants using the AI system needed significantly less coaching while achieving nearly the same weight loss as those in the standard program, suggesting that AI could make weight loss support more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using artificial intelligence to optimize delivery of weight loss treatment: Protocol for an efficacy and cost-effectiveness trial. Forman, EM., Berry, MP., Butryn, ML., et al.[2023]

A study involving 154 overweight or obese patients showed that those referred to an automated Internet-based behavioral weight-loss intervention lost significantly more weight than those in an education-only control group, with average losses of 5.5 kg at 3 months and 5.4 kg at 6 months.

Over half of the participants in the Internet-based intervention achieved a clinically significant weight loss of 5% or more of their initial body weight, indicating the intervention's effectiveness in promoting weight control behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. Thomas, JG., Leahey, TM., Wing, RR.[2022]

The Opt-IN study, involving 562 adults with obesity, identified an effective weight-loss treatment package that included 12 coaching calls, buddy training, and primary care provider reports, resulting in an average weight loss of 6.1 kg for a cost of $427 per person.

By systematically evaluating treatment components, the study found that increasing coaching calls from 12 to 24 did not enhance weight loss, allowing for a more cost-effective and efficient obesity treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. Spring, B., Pfammatter, AF., Marchese, SH., et al.[2021]

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