Weight Loss App for Obesity

Overseen By Marya Schulte, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Weight altering medications

Disqualifiers: Psychiatric conditions, Prader-Willi, others

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

Compensation: Varies

Number of Visits: 5

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app, the BrainWeighve App, designed to help teens manage obesity by changing addictive eating behaviors. The app relies on displacement theory, which suggests that learning healthy habits can replace unhealthy ones. Teens who have struggled with weight issues and are motivated to change might be a good fit if they have access to an iPhone and meet certain health criteria. The study will explore the app's engagement and effectiveness in promoting weight loss and healthier habits. As an unphased trial, this study offers teens a unique opportunity to participate in innovative research that could transform obesity management.

Will I have to stop taking my current medications?

If you are using weight-altering medications like topiramate, phentermine, metformin, or GLP-1 agonists, you will need to stop taking them to participate in this trial.

What prior data suggests that this app is safe for adolescents?

A previous study found that the BrainWeighve app helped teens with obesity learn healthy habits through a smartphone platform. Although detailed information about side effects from this app is limited, using a smartphone app for weight loss is generally considered safe. Similar app-based treatments have not reported major negative effects, suggesting that the BrainWeighve app is likely well-tolerated. By focusing on teaching healthy behaviors, the app avoids surgery or medication, making it a safer option for teens managing their weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BrainWeighve app because it offers a fresh approach to tackling obesity, especially in teens. Unlike traditional weight loss methods, which often focus on diet and exercise alone, BrainWeighve is a smartphone-based intervention rooted in the displacement theory of addictive behaviors. This means it aims to help users replace unhealthy habits with healthier ones by leveraging technology—a method that's both engaging and easily accessible for young people. By addressing the psychological aspects of obesity in a tech-savvy way, BrainWeighve could potentially offer a more sustainable weight loss solution for teenagers.

What evidence suggests that the BrainWeighve App is effective for obesity?

Research has shown that weight loss apps can help people manage their weight by encouraging healthier habits. In this trial, participants will use the BrainWeighve app, which is based on the idea that learning healthy coping mechanisms can replace unhealthy ones, such as overeating. Early results suggest that active users of the app experience weight loss, lower BMI (Body Mass Index), and reduced overeating. The app uses interactive tools to help teens make lasting changes to their eating habits. While more data is still being collected for this specific app, other studies have shown promise in using apps for weight management. ^{5 6 7 8 9}

Who Is on the Research Team?

Marya Schulte, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adolescents aged 14-18 with obesity (BMI ≥95th percentile) who are motivated to lose weight, can read and speak English, and have access to an iPhone. They should not be on weight-altering medications or have certain medical conditions like Prader-Willi Syndrome. Those already in another weight loss program or with psychiatric conditions that could interfere with the study cannot join.

Inclusion Criteria

A score of ≥17 on the Goals and Attitudes section of the Weight Management Program Diet Readiness Questionnaire

Has an iPhone or are willing to use a study iPhone

I am motivated to change based on a specific questionnaire.

Exclusion Criteria

Concurrent participation in an alternative weight loss intervention

Participation in the study team's previous app weight loss studies (exclusion for trial but not beta testing participants)

Any psychiatric condition and/or developmental delay which would require immediate or ongoing treatment that would make study participation difficult or harmful

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Beta Testing

Two successive groups of 8 teens test the app for three weeks each, providing feedback for app modifications.

6 weeks

2 visits (in-person) per group

Trial Stage

30 adolescents participate in a four-month intervention using the app, with assessments at baseline, post-intervention, and one-month post-intervention.

4 months

3 visits (2 in-person, 1 virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, focusing on clinical outcomes and app engagement.

1 month

What Are the Treatments Tested in This Trial?

Interventions

• BrainWeighve App

Trial Overview The BrainWeighve app, based on displacement theory, is being tested as a tool for managing obesity in teenagers. The study involves beta testing by groups of teens followed by a four-month trial period where engagement, satisfaction, and the app's impact on clinical outcomes such as weight/BMI and food-related addictive behaviors will be evaluated.

How Is the Trial Designed?

Group I: BrainWeighve Intervention Experimental Treatment 1 Intervention

4-month smartphone-based weight loss intervention for teens based on displacement theory of addictive behaviors

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

eHealth International, INC.

Collaborator

Trials

2

Recruited

70+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

The study identified 28,905 weight-management apps across various platforms, highlighting the popularity of mobile health (mHealth) solutions for addressing overweight and obesity, with a focus on physical activity (34%) and diet (31%).

Despite the abundance of these apps, only 17 (0.05%) included identifiable professional input from dietitians or nutritionists, indicating a significant gap in expert content that could enhance their effectiveness and safety for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications for obesity and weight management: current market characteristics. Nikolaou, CK., Lean, ME.[2018]

This clinical trial will evaluate a personalized cognitive-behavioral smartphone app designed to support behavioral weight loss (BWL) treatment in 90 adults with severe obesity over 6 months, aiming to improve weight management skills and overall well-being.

The primary outcome will measure weight loss at 6 months compared to pretreatment, while secondary outcomes will assess the app's feasibility, acceptance, and its impact on weight management skills and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL). Hilbert, A., Juarascio, A., Prettin, C., et al.[2023]

The NoHoW project developed a digital toolkit aimed at promoting long-term weight management, tested in an 18-month randomized controlled trial involving adults who had lost at least 5% of their body weight in the previous year.

The toolkit included 34 sessions across 15 modules, utilizing web-based tools and digital tracking devices to target weight, physical activity, and dietary behaviors, demonstrating a systematic approach to behavior change that could enhance weight loss maintenance strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study. Marques, MM., Matos, M., Mattila, E., et al.[2022]

The OBINTER platform is a comprehensive mobile application designed to support long-term weight loss by integrating personalized diet plans, activity tracking, and adherence strategies, addressing multiple factors that contribute to successful weight management.

Usability testing of the OBINTER platform showed positive results, indicating that it effectively engages users in their weight loss journey and helps them manage their obesity more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OBINTER: A Holistic Approach to Catalyse the Self-Management of Chronic Obesity. Álvarez, R., Torres, J., Artola, G., et al.[2021]

There is a significant global need for effective and scalable weight loss solutions for the 1.5 billion people affected by obesity, as no single solution has proven universally effective.

Electronic platforms present a promising avenue for weight loss interventions, as they can be developed using existing technology and require less investment, making them more accessible to a larger population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated electronic platforms for weight loss. McCrady-Spitzer, SK., Levine, JA.[2018]

A study involving 22 participants from a weight management clinic in Singapore identified key features that weight loss apps should include for a multi-ethnic population with overweight and obesity, such as comprehensive calorie counters and individualized behavior change recommendations.

Participants emphasized the importance of flexibility in food logging and the need for apps to provide just-in-time reminders about the consequences of their choices, suggesting that future apps could benefit from artificial intelligence to offer personalized support for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential elements of weight loss apps for a multi-ethnic population with high BMI: a qualitative study with practical recommendations. Chew, HSJ., Lim, SL., Kim, G., et al.[2023]

A study of 7007 overweight and obese adults using a weight loss app found that maintaining consistent caloric intake on weekends and Mondays is linked to greater weight loss success.

Women who consumed fewer calories on weekends compared to Mondays lost more weight, while men who had a higher caloric intake on Mondays compared to weekends lost less weight, highlighting the importance of daily caloric patterns in weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between Weekly Patterns of Caloric Intake and Reported Weight Loss Outcomes: Retrospective Cohort Study. Hill, C., Weir, BW., Fuentes, LW., et al.[2019]

Smartphone weight management apps can effectively initiate and sustain weight loss in adults with overweight and obesity, showing a peak loss of 2.18 kg at 3 months, which tapers to 1.63 kg by 12 months.

While these apps primarily help with weight loss, they show minimal impact on other health outcomes like cholesterol levels and blood glucose, suggesting that additional features, such as interactive coaching, may enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustainability of Weight Loss Through Smartphone Apps: Systematic Review and Meta-analysis on Anthropometric, Metabolic, and Dietary Outcomes. Chew, HSJ., Koh, WL., Ng, JSHY., et al.[2022]

Citations

1. ctv.veeva.com ctv.veeva.com/study/brainweighve-weight-loss-app

BrainWeighve Weight Loss App - ClinicalTrials.Veeva The study will examine engagement and satisfaction with the app, as well as the intervention's impact on clinical outcome measures (weight ...

2. withpower.com withpower.com/trial/phase-body-weight-2023-31b25?condition=Weight+Loss&overallStatus=Recruiting&hasNoPlacebo=false

Weight Loss App for Obesity What data supports the effectiveness of the BrainWeighve Weight Loss App treatment for obesity? Research shows that weight loss apps can help people manage ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05530538?keyword=%22Smartphone%22

San Mateo Clinical Trial BrainWeighve Weight Loss App ... outcomes; specifically, participants more engaged in the app will show reductions in weight and BMI, over-eating behaviors (self-reported diet recall and ...

4. brainweighve.com brainweighve.com/study/

Study Page A new study that is looking at a smartphone- based intervention for weight loss in teens. No health insurance is required.

5. clinicaltrial.be clinicaltrial.be/fr/details/14960?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

BrainWeighve Weight Loss App - Découvrir facilement des ... Découvrez les derniers essais cliniques, études de recherche et avancées médicales révolutionnaires grâce à notre plateforme complète et ...

6. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT05530538

BrainWeighve Weight Loss App - Clinical Trials at UCLA Aim 1: To develop a smartphone app aimed at reducing over-eating behaviors among adolescents with obesity based on the theory that addictive ...

7. trialx.com trialx.com/trialx-updates-simplifying-clinical-trials-with-ai-health-data-regulations-in-patient-recruitment-and-more/

Health Data Regulations for Patient Recruitment Platforms ... BrainWeighve Weight Loss App: This study will use a smartphone app to help overweight teens (14-18 years old) learn healthy habits and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9980333/

Smartphone-supported behavioural weight loss treatment ... This clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients' ...

9. decentrialz.com decentrialz.com/clinical-trials/NCT05530538/BrainWeighve%20Weight%20Loss%20App

BrainWeighve Weight Loss App Some data on this platform is sourced from www.clinicaltrials.gov, which is owned and maintained by the National Institutes of Health (NIH) https://www.nih ...