Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05530538
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2022-08-25
Brief Title:
BrainWeighve Weight Loss App
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
A Displacement Theory Mobile Health Weight Loss Intervention A Pilot Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 46 total adolescents 14-18 years old with BMIp95 will be recruited via various sources eg 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 interventions impact on clinical outcome measures weight and BMI diet and snacking and addictive behaviors related to food and substance use and potential mediatorsmoderators motivation for change perceived stress and distress tolerance
Detailed Description:
Aim 1 To develop a smartphone app aimed at reducing over-eating behaviors among adolescents with obesity based on the theory that addictive behaviors are driven by a displacement mechanism in the brain Based on displacement theory over-eating and associated weight gain are the result of situations that individuals feel they cannot successfully face nor avoid App development will include input from various stakeholders including obesity medicine specialists pediatric clinicians psychologists and individuals living with obesity
Aim 2 To test and modify the app through an iterative process two successive groups 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
Aim 3 Evaluate the feasibility of the app among 30 adolescents 15F15M to identify barriers and facilitators to its implementation We will measure a adherence to daily app use with particular focus on the participants identification of a Dread List and the implementation of Action Plans aimed at ameliorating stressful situations identified in the list b quantity hours per participant and quality type and frequency of team member engagement per participant of support required to promote adherence c satisfaction with the app intervention qualitative assessment of satisfaction rates exit interviews reason for dropouts and d assessment burden This knowledge will inform the refinement of the intervention for the subsequent larger trial
Aim 4 Preliminary assessment of the impact of app engagement and usage on clinical outcome measures weight and BMI diet and snacking and addictive behaviors related to food and substance use and potential mediatorsmoderators motivation for change perceived stress and distress tolerance
Hypothesis 1 More engagement with and use of the app will be related to better clinical outcomes specifically participants more engaged in the app will show reductions in weight and BMI over-eating behaviors self-reported diet recall and snacking and overall addictive behaviors
Hypothesis 2 Participants with greater motivation lower perceived stress and greater distress tolerance at intake will engage more with the app and have better clinical outcomes also those who engage with and use the app more will exhibit increased motivation lowered perceived stress and greater distress tolerance which will in turn result in better clinical outcomes
Aim 2 To test and modify the app through an iterative process two successive groups 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
Aim 3 Evaluate the feasibility of the app among 30 adolescents 15F15M to identify barriers and facilitators to its implementation We will measure a adherence to daily app use with particular focus on the participants identification of a Dread List and the implementation of Action Plans aimed at ameliorating stressful situations identified in the list b quantity hours per participant and quality type and frequency of team member engagement per participant of support required to promote adherence c satisfaction with the app intervention qualitative assessment of satisfaction rates exit interviews reason for dropouts and d assessment burden This knowledge will inform the refinement of the intervention for the subsequent larger trial
Aim 4 Preliminary assessment of the impact of app engagement and usage on clinical outcome measures weight and BMI diet and snacking and addictive behaviors related to food and substance use and potential mediatorsmoderators motivation for change perceived stress and distress tolerance
Hypothesis 1 More engagement with and use of the app will be related to better clinical outcomes specifically participants more engaged in the app will show reductions in weight and BMI over-eating behaviors self-reported diet recall and snacking and overall addictive behaviors
Hypothesis 2 Participants with greater motivation lower perceived stress and greater distress tolerance at intake will engage more with the app and have better clinical outcomes also those who engage with and use the app more will exhibit increased motivation lowered perceived stress and greater distress tolerance which will in turn result in better clinical outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None