N/A
N=161
An Addiction-Based Mobile Health Weight Loss Intervention With Coaching
Pediatric Obesity · Mobile Technology · Addiction
Bottom Line
View on ClinicalTrials.gov: NCT03500835 ↗Enrolled (actual)
161
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: %BMIp95 — -1.9; -1.2; -1.5 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- App (Behavioral); Coaching (Behavioral); Clinic: Modified KidsNFitness (Behavioral)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Los Angeles
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY %BMIp95 |
-1.9; -1.2; -1.5 | — |
| SECONDARY Cost Analysis |
2076; 1122; 4034 | — |
| SECONDARY Yale Food Addiction Scale |
-0.5; -0.5; 0 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Age 14-18 years
- Body mass index [BMI] ≥85th percentile for age and gender
Exclusion Criteria
- Concurrent participation in an alternative weight loss intervention
- Blood pressure > 99th percentile for age, gender, and height
- Known poorly controlled psychiatric illness and/or developmental delay
- Participants Inability to read English
Data sourced from ClinicalTrials.gov (NCT03500835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.