An Addiction-Based Mobile Health Weight Loss Intervention With Coaching
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03500835|
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : July 14, 2020
New and creative approaches are needed to address childhood obesity. Current strategies result in suboptimal outcomes and are intensive and costly. It has been theorized that overeating, may have addictive qualities, although few weight management interventions have tested therapeutic techniques founded on addiction medicine principles, such as, withdrawal, tolerance and craving control1, 2. A pilot study utilizing an addiction model based mobile health (mHealth) weight-loss intervention in adolescents showed that the app intervention reduced BMI Z-score (zBMI) to a greater extent than youth participating in an in-clinic multidisciplinary weight management intervention, and appeared to be a cost-effective, labor efficient method for adolescent weight management.
The proposed multi-site randomized control trial (RCT) will test the effectiveness of an addiction-based weight loss intervention, embodied first as a smartphone app with telephone coaching and second as an identical approach phone-coaching alone intervention compared to age matched controls participating in an in-clinic weight management interventions in a larger sample of economically, racially and ethnically diverse adolescents (ages 14-18).
One hundred and eighty adolescents will be recruited from pediatric interdisciplinary weight management clinics operating out of five different hospital systems in Southern California and through targeted mailing to 40 ethnically, racially and economically diverse neighborhoods in Los Angeles County. The adolescents will be randomized 1:1 via stratified block randomization to either receive 1) interactive addiction model based mobile health (mHealth) weight-loss intervention with personalized phone-coaching (AppCoach), 2) interactive addiction model based mHealth weight-loss intervention alone (App) or 3) Multidisciplinary in-clinic weight management program (Clinic). Assessment of the intervention's effect on zBMI and percent over the 95th percentile (%BMIp95), fasting metabolic parameters, addictive eating habits, executive function, and motivation for change will be obtained at enrollment, 3, 6, 12 and 18 months (1 year post intervention follow up). In addition, a real-life economic analysis (cost, cost-saving and non-monetary benefits) analysis will be completed comparing AppCoach to 1) App and 2) Clinic. We will further explore whether primary and secondary outcomes differ by race and whether race moderates the relationship between initial intervention efficacy and prolonged weight maintenance.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Obesity Mobile Technology Addiction||Behavioral: App Behavioral: Coaching Behavioral: Clinic: Modified KidsNFitness||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The proposed multi-site randomized control trial (RCT) will test the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone app with telephone coaching compared 1) an addiction-based weight loss intervention alone and 2) an in-clinic weight management intervention based on a traffic-light based approach in a larger sample of economically, racially and ethnically diverse adolescents (ages 14-18).|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Blocked randomization will be utilized, to ensure the groups are balanced in terms of number of subjects and the distribution of potential confounding variables. Blocked randomization will be used to ensure the number of eligible subjects assigned to each group is equally distributed. Block size will be blinded from the primary investigator performing the study.|
|Primary Purpose:||Supportive Care|
|Official Title:||An Addiction Model Based Mobile Health Weight Loss Intervention With Coaching in Adolescents With Overweight and Obesity: Multi-Site Randomized Controlled Trial|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2023|
Experimental: App Plus Coaching (AC)
6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.
Experimental: App Alone (AA)
6 month addiction model based weight loss intervention in the form of an iPhone app.
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
Behavioral: Clinic: Modified KidsNFitness
- zBMI and %BMIp95 [ Time Frame: 6 and 18 months ]Mean change in zBMI and excess BMI percent over the 95th percentile (%BMIp95)
- Cost Analysis [ Time Frame: 6 months ]Real life economic analysis of the intervention arms compared to each other and in in-clinic intervention
- Yale Food Addiction Scale [ Time Frame: 6 and 18 months ]Evaluate effect of YFAS-c score as a co-variate of program success
- Behavior Rating Inventory of Executive Function [ Time Frame: 6 and 18 months ]Evaluate effect executive function as a co-variate of program success
- Adolescent Self Regulatory Inventory [ Time Frame: 6 and 18 months ]Evaluate effect ARI score as a co-variate of program success
- Food Cravings Questionnaire [ Time Frame: 6 and 18 months ]Evaluate effect of FCQ score as a co-variate of program success
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500835
|Contact: Janelle Gonzalezfirstname.lastname@example.org|
|Contact: Alaina Vidmar, MDemail@example.com|
|United States, California|
|Children's Hospital of Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Janelle Gonzalez 323-361-6446 firstname.lastname@example.org|
|Principal Investigator:||Alaina Vidmar||Children's Hospital Los Angeles|