About 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. 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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
BrainWeighve App
Behavioral38 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).
Treatment groups
Trial outcomes
Primary outcomes
Quantity of Engagement with App
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
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
Number of items participant enters over the intervention period for their Dread List and Action Plans
Secondary outcomes
%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.
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)
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)
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)
Other outcomes
Reach and Retention Rates
Participation rates; characteristics of participants vs. non-participants; attrition rates; enrollment rates based on recruitment source
Sponsors and contacts
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University of California, Los Angeles
Lead sponsor
Children's Hospital Los Angeles
Collaborator
eHealth International, INC.
Collaborator