At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Addiction Model Based Mobile Health Weight Loss Intervention With Coaching in Adolescents With Overweight and Obesity: Multi-Site Randomized Controlled Trial
In Brief
A clinical study evaluating App, Coaching, and 1 other intervention for Pediatric Obesity and 2 related conditions. Completed, enrolled 161 participants across 1 site.
Detailed Summary
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).
Study Details
Timeline
Interventions
1. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction 2. Daily Weigh In 3. App based reminders 4. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
1. 6 month addiction based intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction. 2. Daily Weighing 3. Daily Text messages from Coach 4. Weekly 15 minute phone meetings with Coach 5. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months post consent
1. 6 month in-clinic, evidence-based, multi-disciplinary intervention 2. 90 minute sessions, in clinic that occur every month for 6 months 3. Follow Up: Face-to-face clinic visits Monthly x 6 months followed by face-to-face visit at12 and 18 months.