46 Participants Needed

Weight Loss App for Obesity

MS
Overseen ByMarya Schulte, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the BrainWeighve Weight Loss App treatment for obesity?

Research shows that weight loss apps can help people manage their weight by offering personalized recommendations, tracking diet and physical activity, and providing reminders for behavior change. These features, which are similar to those in the BrainWeighve App, have been found to support long-term weight loss and self-management in people with obesity.12345

How does the BrainWeighve Weight Loss App treatment differ from other treatments for obesity?

The BrainWeighve Weight Loss App is unique because it likely incorporates personalized, cognitive-behavioral strategies to support weight management skills in everyday life, which is not commonly found in traditional weight loss treatments. This app-based approach may offer tailored recommendations and just-in-time reminders, leveraging technology to enhance user engagement and adherence.24678

What is the purpose of this trial?

Childhood obesity within the United States has been a growing concern over the past number of years, and if not addressed, leads to detrimental health outcomes for youth as they move into adulthood. The literature suggests that over-eating, especially when framed in terms of food addiction, plays a key role in this epidemic; however, treatment options are time intensive, posing a profound logistical barrier for both the child and parent and often limits or prevents engagement. As research within the field of mHealth has grown, technology-based interventions have gained traction, specifically interactive smartphone applications (apps). Displacement theory, although not new, has been understudied yet provides a strong explanation and treatment plan for addictive type behaviors. The core of this theory posits that problems which one feels they cannot face nor avoid leads to repetitive and irrepressible behaviors; however, if a healthy coping behavior can be learned and utilized, then the unhealthy behavior will cease. The theory lends itself well to being adapted into an mHealth format, making it more easily accessible and more widely used. Grounded in displacement theory, the proposed study aims to develop an app-based weight loss intervention for adolescents with obesity. Information gained regarding the feasibility and acceptability of such an intervention can potentially be replicated and applied to other populations with various addictive behaviors. Helping those with addictive behaviors in a format that has little to no logistical barriers can have a substantial impact on public health. A novel smartphone app will be designed by key stakeholders and refined through the course of the study. 46 total adolescents (14-18 years old) with %BMIp95 will be recruited via various sources (e.g., clinic referrals, flyers, social media advertising) to participate in one of two stages of the study: the beta testing stage or the trial stage. Beta testing will enroll two successive groups of eight teens to test the app for three weeks; participants will be assessed in-person pre- and post-intervention. After each group, the app will be modified to incorporate their feedback in order to promote youth engagement. The trial stage will enroll 30 adolescents to participate in a four-month intervention; participants will complete three assessments, baseline, post-intervention (both in-person) and one-month post-intervention (either in-person or virtually). The study will examine engagement and satisfaction with the app, as well as the intervention's impact on clinical outcome measures (weight and BMI, diet and snacking, and addictive behaviors related to food and substance use) and potential mediators/moderators (motivation for change, perceived stress, and distress tolerance).

Research Team

MS

Marya Schulte, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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.
See 1 more

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
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BrainWeighve InterventionExperimental Treatment1 Intervention
4-month smartphone-based weight loss intervention for teens based on displacement theory of addictive behaviors

Find a Clinic Near You

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+

Findings from Research

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

References

Mobile applications for obesity and weight management: current market characteristics. [2018]
Essential elements of weight loss apps for a multi-ethnic population with high BMI: a qualitative study with practical recommendations. [2023]
A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study. [2022]
OBINTER: A Holistic Approach to Catalyse the Self-Management of Chronic Obesity. [2021]
Sustainability of Weight Loss Through Smartphone Apps: Systematic Review and Meta-analysis on Anthropometric, Metabolic, and Dietary Outcomes. [2022]
Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL). [2023]
Relationship Between Weekly Patterns of Caloric Intake and Reported Weight Loss Outcomes: Retrospective Cohort Study. [2019]
Integrated electronic platforms for weight loss. [2018]
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