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Behavioral Intervention
Mobile Health App + Coaching for Obesity
N/A
Waitlist Available
Led By Alaina Vidmar
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will address whether an addiction-based weight loss intervention, in the form of a smartphone app with telephone coaching, is more effective than an identical app-based intervention or a standard multidisciplinary clinic-based weight management program in reducing BMI in a diverse group of adolescents.
Who is the study for?
This trial is for adolescents aged 14-18 with obesity, defined as having a BMI at or above the 85th percentile for their age and gender. They must be able to read English and not be involved in other weight loss programs, have high blood pressure, or poorly controlled psychiatric illnesses.
What is being tested?
The study tests an addiction-based mobile health (mHealth) weight-loss intervention using a smartphone app with coaching versus phone-coaching alone compared to traditional in-clinic treatment. It aims to see if managing overeating like an addiction can help teens lose weight more effectively.
What are the potential side effects?
Since this trial involves non-medical interventions such as coaching and app usage, typical medical side effects are not expected. However, participants may experience psychological effects related to changes in eating habits and lifestyle adjustments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
zBMI and %BMIp95
Secondary study objectives
Adolescent Self Regulatory Inventory
Behavior Rating Inventory of Executive Function
Cost Analysis
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: ClinicExperimental Treatment1 Intervention
In-Clinic Multi-disciplinary monthly weight management program. Curriculum adapted from the KidsNFitness Program and administered by an MD, RD, Psychologist and Health Educator over 90 minute sessions
Group II: App Plus Coaching (AC)Experimental Treatment2 Interventions
6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.
Group III: App Alone (AA)Experimental Treatment1 Intervention
6 month addiction model based weight loss intervention in the form of an iPhone app.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coaching
2016
Completed Phase 3
~5600
App
2018
Completed Phase 4
~470
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterOTHER
509 Previous Clinical Trials
162,597 Total Patients Enrolled
University of California, Los AngelesOTHER
1,559 Previous Clinical Trials
10,258,710 Total Patients Enrolled
Children's Hospital Los AngelesLead Sponsor
245 Previous Clinical Trials
5,072,942 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mental illness or developmental delay that is not well managed or controlled.You are currently participating in another program or method to lose weight.
Research Study Groups:
This trial has the following groups:- Group 1: Clinic
- Group 2: App Alone (AA)
- Group 3: App Plus Coaching (AC)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Childhood Obesity Patient Testimony for trial: Trial Name: NCT03500835 — N/A
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