RightFit
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BrainWeighve App Feasibility Study

A Displacement Theory Mobile Health Weight Loss Intervention: A Pilot Clinical Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 21 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BrainWeighve, a weight loss app for young people ages 14–21 who have a high weight for their age and gender. The app aims to teach healthy ways to cope instead of overeating. Researchers will study how easy the app is to use, how much users like it, and its effects on weight and eating habits.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 14–21 years old.
  • You have an iPhone or are willing to use one from the study.
  • You can read and speak English.
  • On a survey, you say one of these is true: you did nothing to lose weight in the past year but plan to start in the next 30 days; you have tried to lose weight for less than 6 months; or you have tried to keep your weight steady for more than 6 months.
  • Your BMI, a measure based on height and weight, is at or above the 85th percentile for your age and gender. This means it is as high as or higher than that of 85 out of 100 people your age and gender.

Who can't join

  • You have a mental health condition or a delay in development that needs treatment and would make taking part difficult or harmful.
  • For minors, a parent or guardian reports that they cannot give consent, or they refuse to give permission.
  • You report having Prader-Willi syndrome, a genetic condition linked to obesity; a brain tumor; hypothalamic obesity, weight gain linked to a part of the brain; or another diagnosis linked to obesity.
  • You are taking part in another weight loss program.
  • You joined one of this study team's earlier weight loss app studies. This rule applies to the trial stage, but not the early app-testing stage.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 14-21 years old 2. Has an iPhone or are willing to use a study iPhone 3. Ability to read and speak English 4. 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 Exclusion Criteria: 1. Any psychiatric condition and/or developmental delay which would require immediate or ongoing treatment that would make study participation difficult or harmful 2. Parent/guardian-reported physical, mental of other inability to provide consent or refusal to provide consent for minor children 3. Self-reported diagnosis of Prader-Willi Syndrome, brain tumor, hypothalamic obesity, or other diagnosis associated with obesity 4. Concurrent participation in an alternative weight loss intervention 5. Participation in the study team's previous app weight loss studies (exclusion for trial but not beta testing participants)

Study sites (1)

CA