Weight Loss App for Obesity
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Beta Testing
Two successive groups of 8 teens test the app for three weeks each, providing feedback for app modifications.
Trial Stage
30 adolescents participate in a four-month intervention using the app, with assessments at baseline, post-intervention, and one-month post-intervention.
Follow-up
Participants are monitored for safety and effectiveness after the intervention, focusing on clinical outcomes and app engagement.
Treatment Details
Interventions
- BrainWeighve App
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
eHealth International, INC.
Collaborator
Children's Hospital Los Angeles
Collaborator