BrainWeighve App Feasibility Study

NCT05530538 | Recruiting

• 1 other identifier: 22-1395
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Weight Loss; Obesity and Overweight

Keywords

Weight Loss; Adolescents; Smartphone App; Obesity; Overweight

Outcome Measures

Primary Outcomes (3)

• Quantity of Engagement with App

  Daily engagement as measured by minutes per day each participant spent in the app

  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.

  4 months

• Quality of Engagement with App

  Number of items participant enters over the intervention period for their Dread List and Action Plans

  4 months

Secondary Outcomes (10)

• %BMI95

  5 months

• Automated Self-Administered 24-Hour Dietary Assessment Tool

  5 months

• Substance Use as measured by the NIDA Risk Assessment

  5 months

• Perceived Stress Scale

  5 months

• Distress Tolerance Scale

  5 months

Other Outcomes (1)

• Reach and Retention Rates

  4 months

Study Arms (1)

BrainWeighve Intervention

EXPERIMENTAL

4-month smartphone-based weight loss intervention for teens based on displacement theory of addictive behaviors

Behavioral: BrainWeighve App

Interventions

BrainWeighve App BEHAVIORAL

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).

BrainWeighve Intervention

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• \. Body mass index \[BMI\] ≥85th percentile for age and gender

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Children's Hospital Los Angeles: collaborator
• eHealth International, INC.: collaborator

Study Sites (1)

UCLA Marion Davies Children's Center

Los Angeles, California, 90025, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss; Obesity; Overweight

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Vibha Singhal, MD, MBBS, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Huynh

CONTACT

3108939522; amhuynh@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 7, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-04

Locations

US (1)