BrainWeighve App for Weight Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA Integrated Substance Abuse Programs, Los Angeles, CA
Weight Loss+1 More
BrainWeighve App - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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. 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).

Eligible Conditions

  • Weight Loss

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: 5 months

4 months
Quality of Engagement with App
Quantity of Engagement with App
Reach and Retention Rates
Satisfaction with the App as assessed by the Treatment Satisfaction Questionnaire
5 months
%BMI95
Automated Self-Administered 24-Hour Dietary Assessment Tool
Distress Tolerance Scale
International Physical Activity Questionnaire
Mental Health Inventory
Nicotine use as measured by the CRAFFT section C
Perceived Stress Scale
Substance Use as measured by the NIDA Risk Assessment
Weight Management Program Diet Questionnaire
Yale Food Addiction Scale

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

BrainWeighve Intervention
1 of 1
Experimental Treatment

46 Total Participants · 1 Treatment Group

Primary Treatment: BrainWeighve App · No Placebo Group · N/A

BrainWeighve Intervention
Behavioral
Experimental Group · 1 Intervention: BrainWeighve App · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 months
Closest Location: UCLA Integrated Substance Abuse Programs · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
2008First Recorded Clinical Trial
1 TrialsResearching Weight Loss
8 CompletedClinical Trials

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,381 Previous Clinical Trials
6,521,101 Total Patients Enrolled
8 Trials studying Weight Loss
507 Patients Enrolled for Weight Loss
Children's Hospital Los AngelesOTHER
203 Previous Clinical Trials
5,072,170 Total Patients Enrolled
2 Trials studying Weight Loss
361 Patients Enrolled for Weight Loss
eHealth International, INC.UNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Weight Loss
20 Patients Enrolled for Weight Loss
Marya Schulte, PhDPrincipal InvestigatorUniversity of California, Los Angeles

Eligibility Criteria

Age < 65 · All Participants · 8 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.