NCT05530538 · University of California, Los Angeles
BrainWeighve App Feasibility Study
What this study is about
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.
View original scientific description
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. 38 total adolescents (14-21 years old) with %BMIp85 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 one group 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).
Interventions
BEHAVIORAL
BrainWeighve App
38 total adolescents (14-21 years old) with %BMIp85 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 a group of eight teens to test the app for three weeks; participants will be assessed pre- and post-intervention. 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).
Primary outcome measures
Quantity of Engagement with App
Time frame: 4 months
Daily engagement as measured by minutes per day each participant spent in the app
Satisfaction with the App as assessed by the Treatment Satisfaction Questionnaire
Time frame: 4 months
The TSQ (Cox, Fergus \& Swinson, 1994) will be modified and used for this study to provide a quantitative assessment of participant satisfaction with the BrainWeighve app. The measure contains a nine item Likert-scale asking the participant to rate how satisfied they were with the app overall, its ease or difficulty of use, how satisfied they were with the impact the app had on their behaviors and weight loss, and if they would be likely to continue using it outside of a research study.
Quality of Engagement with App
Time frame: 4 months
Number of items participant enters over the intervention period for their Dread List and Action Plans
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 14-21 years old
- Has an iPhone or are willing to use a study iPhone
- Ability to read and speak English
- Endorsement of one of the three items listed below on the five-item S-weight questionnaire indicating motivation for change During the last year I haven't done anything to lose weight but I'm planning to do something over the next 30 days. I've been making an effort to lose weight (by dieting1 and/or exercising2) for less than 6 months. I've been making an effort to maintain my weight (by dieting1 and/or exercising2) for more than 6 months. 6\. Body mass index \[BMI\] ≥85th percentile for age and gender
Exclusion criteria
- Any psychiatric condition and/or developmental delay which would require immediate or ongoing treatment that would make study participation difficult or harmful
- Parent/guardian-reported physical, mental of other inability to provide consent or refusal to provide consent for minor children
- Self-reported diagnosis of Prader-Willi Syndrome, brain tumor, hypothalamic obesity, or other diagnosis associated with obesity
- 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)
Where
- Los Angeles, California
Collaborators
Children's Hospital Los Angeles, eHealth International, INC.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 22, 2025 · Source of record for eligibility and locations