An Addiction-Based Mobile Health Weight Loss Intervention With Coaching

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).

Conditions

• Pediatric Obesity
• Mobile Technology
• Addiction

Interventions

BEHAVIORAL

App

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.

BEHAVIORAL

Coaching

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

BEHAVIORAL

Clinic: Modified KidsNFitness

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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  collaborator OTHER

• Children's Hospital Los Angeles

  lead OTHER

Principal Investigators

• Alaina Vidmar · Children's Hospital Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2022-12-01

Completion

2023-12-19

Countries

• United States

Study Locations