Weight Loss App for Obesity
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Must not be taking: Weight altering medications
Disqualifiers: Psychiatric conditions, Prader-Willi, others
No Placebo Group
Trial Summary
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).
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.
12345How 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.
24678Eligibility 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
Ability to read and speak English
Has an iPhone or are willing to use a study iPhone
+3 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
+3 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
UCLA Integrated Substance Abuse ProgramsLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
eHealth International, INC.Collaborator
Children's Hospital Los AngelesCollaborator
References
Mobile applications for obesity and weight management: current market characteristics. [2018]Mobile-Health (mHealth) is the fastest-developing eHealth sector, with over 100 000 health applications (apps) currently available. Overweight/obesity is a problem of wide public concern that is potentially treatable/preventable through mHealth. This study describes the current weight-management app-market. Five app stores (Apple, Google, Amazon, Windows and Blackberry) in UK, US, Russia, Japan and Germany, Italy, France, China, Australia and Canada were searched for keywords: 'weight', 'calorie', 'weight-loss', 'slimming', 'diet', 'dietitian' and 'overweight' in January/February 2016 using App-Annie software. The 10 most downloaded apps in the lifetime of an app were recorded. Developers' lists and the app descriptions were searched to identify any professional input with keywords 'professional', 'dietitian' and 'nutritionist'. A total of 28 905 relevant apps were identified as follows: Apple iTunes=8559 (4634, 54% paid), Google Play=1762 (597, 33.9% paid), Amazon App=13569 (4821, 35.5% paid), Windows=2419 (819, 17% paid) and Blackberry=2596 (940, 36% paid). The 28 905 identified apps focused mainly on physical activity (34%), diet (31%), and recording/monitoring of exercise, calorie intake and body weight (23%). Only 17 apps (0.05%) were developed with identifiable professional input. Apps on weight management are widely available and very popular but currently lack professional content expertise. Encouraging app development based on evidence-based online approaches would assure content quality, allowing healthcare professionals to recommend their use.
Essential elements of weight loss apps for a multi-ethnic population with high BMI: a qualitative study with practical recommendations. [2023]Smartphone weight loss apps are constantly being developed but the essential elements needed by a multi-ethnic population with overweight and obesity remains unclear. Purpose: To explore the perceptions of an Asian multi-ethnic population with overweight and obesity on the essential elements of weight loss apps. Twenty two participants were purposively sampled from a specialist weight management clinic in Singapore from 13 April to 30 April 2021. Recorded interviews were conducted using face-to-face and videoconferencing modalities. Data saturation was reached at the 18th participant. Data analysis was performed using inductive content analysis with constant comparison between and within transcripts. Findings: Three themes and eight subthemes on the essential app components emerged-(a) comprehensive and flexible calorie counters; (b) holistic, gradual and individualized behavior change recommendations tailored for people with overweight and obesity, and (c) just-in-time reminders of future consequences. There was a need to incorporate flexible options for food logging; break down general recommendations into small steps towards sustainable changes; tailor app contents for people with overweight and obesity; and evoke one's considerations of future consequences. Future weight loss apps should be designed to meet the needs of those with overweight and obesity, the very population that needs assistance with weight loss. Future apps could consider leveraging the capacity of artificial intelligence to provide personalized weight management in terms of sustaining self-regulation behaviors, optimizing goal-setting and providing personalized and timely recommendations for weight loss.
A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study. [2022]Many weight loss programs show short-term effectiveness, but subsequent weight loss maintenance is difficult to achieve. Digital technologies offer a promising means of delivering behavior change approaches at low costs and on a wide scale. The Navigating to a Healthy Weight (NoHoW) project, which was funded by the European Union's Horizon 2020 research and innovation program, aimed to develop, test, and evaluate a digital toolkit designed to promote successful long-term weight management. The toolkit was tested in an 18-month, large-scale, international, 2×2 factorial (motivation and self-regulation vs emotion regulation) randomized controlled trial that was conducted on adults with overweight or obesity who lost ≥5% of their body weight in the preceding 12 months before enrollment into the intervention.
OBINTER: A Holistic Approach to Catalyse the Self-Management of Chronic Obesity. [2021]Obesity is a preventable chronic condition that, in 2016, affected more than 1.9 billion people globally. Several factors have been identified that have a positive impact on long-term weight loss programs such as personalized recommendations, adherence strategies, weight and diet follow-up or physical activity tracking. Recently, various applications have been developed which help patients to self-manage their condition. These apps implement either one or some of these identified factors; however, there is not a single application that combines all of them following a holistic approach. In this context, we developed the OBINTER platform, which assists patients during the weight loss process by targeting user engagement during the longer term. The solution includes a mobile application which allows users to fill out dietetic questionnaires, receive dietetic and nutraceutical plans, track the evolution of their weight and adherence to the diet, as well as track their physical activity via a wearable device. Furthermore, an adherence strategy has been developed as a tool to foster the app usage during the whole weight loss process. In this paper, we present how the OBINTER approach gathers all of these features as well as the positive results of a usability testing study performed to assess the performance and usability of the OBINTER platform.
Sustainability of Weight Loss Through Smartphone Apps: Systematic Review and Meta-analysis on Anthropometric, Metabolic, and Dietary Outcomes. [2022]Evidence on the long-term effects of weight management smartphone apps on various weight-related outcomes remains scarce.
Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL). [2023]Label="INTRODUCTION">Behavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m2 or ≥35.0 kg/m2 with obesity-related comorbidity), leading to moderate weight loss which often cannot be maintained in the long term. Because weight loss depends on patients' use of weight management skills, it is important to support them in daily life. In an ecological momentary intervention design, this clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients' weight management skills use in everyday life. It is hypothesised that using the app is feasible and acceptable, improves weight loss and increases skills use and well-being.
Relationship Between Weekly Patterns of Caloric Intake and Reported Weight Loss Outcomes: Retrospective Cohort Study. [2019]Although millions of overweight and obese adults use mobile phone apps for weight loss, little is known about the predictors of success.
Integrated electronic platforms for weight loss. [2018]What can be done to build effective weight loss solutions for the 1.5 billion people with obesity? It is self-evident that no one good solution exists for people who are overweight or obese, otherwise it would have been applied across the people who need it worldwide. There is, therefore, an urgent need for approaches that will afford weight loss; what is more, such approaches need to be scalable. For that reason, it is attractive to consider electronic platforms as an avenue for scalable weight loss solutions. Such platforms often do not require substantial investments but rather the integration of pre-existing off-the-shelf components. In this article we explore the concepts and design challenges for electronic platforms that precipitate weight loss.