A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial.
BACKGROUND
There are few evidence-based mobile health solutions for treating adolescent obesity. The primary aim of this parallel non-inferiority trial is to assess the effectiveness of an experimental smartphone application in reducing obesity at 12 months, compared to the Temple Street W82GO Healthy Lifestyles intervention.


METHODS
The primary outcome measure is change in body mass index standardised deviation score at 12 months. The secondary aim is to compare the effect of treatment on secondary outcomes, including waist circumference, insulin sensitivity, quality of life, physical activity and psychosocial health. Adolescents with a body mass index at or above the 98th percentile (12 to 17 years) will be recruited from the Obesity clinic at Temple Street Children's University Hospital in Dublin, Ireland. W82GO is a family-based lifestyle change intervention delivered in two phases over 12 months. In the current study, participants will be randomised for phase two of treatment to either usual care or care delivered via smartphone application. One hundred and thirty-four participants will be randomised between the two study arms. An intention-to-treat analysis will be used to compare treatment differences between the groups at 12 months.


CONCLUSIONS
The results of this study will be disseminated via open access publication and will provide important information for clinicians, patients and policy makers regarding the use of mobile health interventions in the management of adolescent obesity.


BACKGROUND
Clinicaltrials.gov NCT01804855.
Physiotherapy Department, Childhood Obesity Service, Temple Street Children's University Hospital, Temple Street, Dublin 1, Ireland. omalleyg@tcd.ie.
Grace
G
O'Malley
Mike
M
Clarke
Amanda
A
Burls
Sinéad
S
Murphy
Nuala
N
Murphy
Ivan J
IJ
Perry
D000293:Adolescent; D000294:Adolescent Behavior; D000367:Age Factors; D015992:Body Mass Index; D040421:Cell Phone; D002648:Child; D002985:Clinical Protocols; D034201:Computers, Handheld; D015438:Health Behavior; D006801:Humans; D007333:Insulin Resistance; D057194:Intention to Treat Analysis; D007494:Ireland; D063731:Mobile Applications; D009043:Motor Activity; D063766:Pediatric Obesity / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D011788:Quality of Life; D012107:Research Design; D040242:Risk Reduction Behavior; D017216:Telemedicine; D013997:Time Factors; D016896:Treatment Outcome; D055105:Waist Circumference; D015431:Weight Loss