Weight LossNCT05530538
BrainWeighve App Feasibility Study
A study testing BrainWeighve App in people with Weight Loss and Obesity and Overweight, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity and Overweight
- What is being tested?
- BrainWeighve App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA Marion Davies Children's Center
Los Angeles, California, 90025
Ashley Huynh, 3108939522, AMHuynh@mednet.ucla.edu
Vibha Singhal, MD, MBBS, MPH
About this study
Official title: A Displacement Theory Mobile Health Weight Loss Intervention: A Pilot Clinical 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. 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).
Read the detailed description
Aim 1: To develop a smartphone app aimed at reducing over-eating behaviors among adolescents with obesity based on the theory that addictive behaviors are driven by a displacement mechanism in the brain. Based on displacement theory, over-eating and associated weight gain are the result of situations that individuals feel they cannot successfully face nor avoid. App development will include input from various stakeholders including obesity medicine specialists, pediatric clinicians, psychologists, and individuals living with obesity.
Aim 2: To test and modify the app through an iterative process; one group of 8 teens will beta test the app for three weeks each and provide quantitative and qualitative data used to make changes which facilitate usability and engagement.
Aim 3: Evaluate the feasibility of the app among 30 adolescents (15F;15M) to identify barriers and facilitators to its implementation. We will measure (a) adherence to daily app use with particular focus on the participant's identification of a "Dread List" and the implementation of "Action Plans" aimed at ameliorating stressful situations identified in the list, (b) quantity (#hours per participant) and quality (type and frequency of team member engagement per participant) of support required to promote adherence, (c) satisfaction with the app intervention (qualitative assessment of satisfaction rates, exit interviews, reason for dropouts), and (d) assessment burden. This knowledge will inform the refinement of the intervention for the subsequent larger trial.
Aim 4: Preliminary assessment of the impact of app engagement and usage 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).
Hypothesis 1: More engagement with and use of the app will be related to better clinical outcomes; specifically, participants more engaged in the app will show reductions in weight and BMI, over-eating behaviors (self-reported diet recall and snacking), and overall addictive behaviors.
Hypothesis 2: Participants with greater motivation, lower perceived stress, and greater distress tolerance at intake will engage more with the app and have better clinical outcomes; also, those who engage with and use the app more will exhibit increased motivation, lowered perceived stress, and greater distress tolerance which will in turn result in better clinical outcomes.
- Conditions
- Weight Loss, Obesity and Overweight
- Being tested
- BrainWeighve App
- Keywords
- Weight Loss, Adolescents, Smartphone App, Obesity, Overweight
- Medical subject headings
- Weight Loss, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainWeighve AppBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| BrainWeighve Intervention | Experimental | 4-month smartphone-based weight loss intervention for teens based on displacement theory of addictive behaviors Receives: Behavioral: BrainWeighve App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of Engagement with App
Daily engagement as measured by minutes per day each participant spent in the app
Measured: 4 months
Satisfaction with the App as assessed by the Treatment Satisfaction Questionnaire
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.
Measured: 4 months
Quality of Engagement with App
Number of items participant enters over the intervention period for their Dread List and Action Plans
Measured: 4 months
Secondary outcomes (10)
%BMI95
Weight and height; participants will also be asked to enter their daily weight into the app using their study-provided scale. Adolescents will be instructed to wear minimal clothing during the height and weight measurements. BMI will be calculated as kilograms per meter squared and BMI z-score (zBMI) and excess percent of the 85th percentile (%BMIp85) will be determined utilizing the CDC growth charts (baseline, post-treatment, and 1-month post-treatment.
Measured: 5 months
Automated Self-Administered 24-Hour Dietary Assessment Tool
The ASA-24 is a recall measure developed by the US National Cancer Institute that asks participants to self-report all food and beverages consumed within the past 24-hour period (baseline, post, and 1-month post)
Measured: 5 months
Substance Use as measured by the NIDA Risk Assessment
Substance use will be assessed using items drawn from the NIDA Risk Assessment Questionnaire (1993). This scale asks participants to report past 30-day use of alcohol, marijuana, and "other drugs." (baseline, post, 1-month post)
Measured: 5 months
Perceived Stress Scale
The PSS measures subjective perceptions of distress in one's own life situations on a 10-item, 5-point scale. Based on Lazarus' transactional model of stress and coping, the PSS assesses how well a person feels they can cope with stressors, rather than measuring the nature of the stressors themselves. The measure has demonstrated strong reliability (r > 0.80) and validity in social and health science studies (baseline, post, 1-month post)
Measured: 5 months
Distress Tolerance Scale
The DTS (Simons \& Gaher, 2005) is a 15-item self-report measure of ability to withstand emotional distress, measuring four factors: tolerance, appraisal, absorption, and regulation (alpha=.82). (baseline, post, 1-month post)
Measured: 5 months
Mental Health Inventory
One item from the RAND MHI (Veit \& Ware, 1983) will be used to provide a general assessment of mental health well-being on a 6-point Likert scale of Extremely Happy to Very Dissatisfied (i.e., "How happy, satisfied, or pleased have you been with your personal life during the past month?"). (baseline, post, 1-month post)
Measured: 5 months
Weight Management Program Diet Questionnaire
A 23-item validated measure used to assess readiness and willingness to make behavioral changes to lose weight. Items are measured on a 5-point Likert scale and are organized into six categories (Goals and Attitudes, Hunger and Eating Cues, Control Over-eating, Binge Eating and Purging, Emotional Eating, Exercise Patterns and Attitudes). (baseline, post, 1-month post)
Measured: 5 months
Yale Food Addiction Scale
The YFAS-c is a validated measure of addictive-like eating behavior based on the Diagnostic and Statistical Manual of Mental Disorder V diagnostic criteria for substance use disorders. (baseline, post, 1-month post)
Measured: 5 months
International Physical Activity Questionnaire
The IPAQ is a seven item self-report questionnaire that asks how much time the participant has engaged in physical activity during the past seven days, including mild to vigorous activity. (baseline, post, 1-month post)
Measured: 5 months
Nicotine use as measured by the CRAFFT section C
Nicotine use (vaping or other tobacco products) will be assessed using Part C of the CRAFFT; it will be modified to assess past 30-day use rather than past year (Mitchell, Kelly, Gryczynski, Myers, O'Grady, Kirk, \& Schwartz, 2014). (baseline, post, 1-month post)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles, eHealth International, INC.
- Responsible party
- Principal investigator, Vibha Singhal, University of California, Los Angeles
- Investigators
- Vibha Singhal, MD, MBBS, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530538
- Sponsor's protocol ID
- 22-1395
- Status last verified
- Apr 2025
- First submitted
- 25 Aug 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Displacement Theory Mobile Health Weight Loss Intervention: A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT05530538
- Acronym / sponsor ID
- 22-1395
- Conditions
- Weight Loss, Obesity and Overweight
- Keywords
- Weight Loss, Adolescents, Smartphone App, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles, eHealth International, INC.
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Aim 1: To develop a smartphone app aimed at reducing over-eating behaviors among adolescents with obesity based on the theory that addictive behaviors are driven by a displacement mechanism in the brain. Based on displacement theory, over-eating and associated weight gain are the result of situations that individuals feel they cannot successfully face nor avoid. App development will include input from various stakeholders including obesity medicine specialists, pediatric clinicians, psychologists, and individuals living with obesity.
Aim 2: To test and modify the app through an iterative process; one group of 8 teens will beta test the app for three weeks each and provide quantitative and qualitative data used to make changes which facilitate usability and engagement.
Aim 3: Evaluate the feasibility of the app among 30 adolescents (15F;15M) to identify barriers and facilitators to its implementation. We will measure (a) adherence to daily app use with particular focus on the participant's identification of a "Dread List" and the implementation of "Action Plans" aimed at ameliorating stressful situations identified in the list, (b) quantity (#hours per participant) and quality (type and frequency of team member engagement per participant) of support required to promote adherence, (c) satisfaction with the app intervention (qualitative assessment of satisfaction rates, exit interviews, reason for dropouts), and (d) assessment burden. This knowledge will inform the refinement of the intervention for the subsequent larger trial.
Aim 4: Preliminary assessment of the impact of app engagement and usage 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).
Hypothesis 1: More engagement with and use of the app will be related to better clinical outcomes; specifically, participants more engaged in the app will show reductions in weight and BMI, over-eating behaviors (self-reported diet recall and snacking), and overall addictive behaviors.
Hypothesis 2: Participants with greater motivation, lower perceived stress, and greater distress tolerance at intake will engage more with the app and have better clinical outcomes; also, those who engage with and use the app more will exhibit increased motivation, lowered perceived stress, and greater distress tolerance which will in turn result in better clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BrainWeighve Intervention | Experimental | Behavioral: BrainWeighve App4-month smartphone-based weight loss intervention for teens based on displacement theory of addictive behaviors |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainWeighve App38 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). | Behavioural | BrainWeighve Intervention |
Primary outcome
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
10 secondary outcomes
%BMI95
Time frame: 5 months
Automated Self-Administered 24-Hour Dietary Assessment Tool
Time frame: 5 months
Substance Use as measured by the NIDA Risk Assessment
Time frame: 5 months
Perceived Stress Scale
Time frame: 5 months
Distress Tolerance Scale
Time frame: 5 months
Mental Health Inventory
Time frame: 5 months
Weight Management Program Diet Questionnaire
Time frame: 5 months
Yale Food Addiction Scale
Time frame: 5 months
International Physical Activity Questionnaire
Time frame: 5 months
Nicotine use as measured by the CRAFFT section C
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vibha Singhal, MD, MBBS, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainWeighve App in people with Weight Loss and Obesity and Overweight, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Huynh (3108939522, amhuynh@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of Engagement with App (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.