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Open Access Study protocol

A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial

Grace O’Malley127*, Mike Clarke3, Amanda Burls4, Sinéad Murphy5, Nuala Murphy6 and Ivan J Perry2

Author Affiliations

1 Physiotherapy Department, Childhood Obesity Service, Temple Street Children’s University Hospital, Temple Street, Dublin 1, Ireland

2 Department of Epidemiology and Public Health, University College Cork Western Gateway Building, Western Road, Cork, Ireland

3 MRC Hub for Trials Methodology Research, Institute of Clinical Sciences, Block B, Queens University Belfast, Royal Vctoria Hospital, Belfast BT12 6BA, Ireland

4 School of Health Sciences, Northampton Square, London EC1V 0HB, UK

5 Obesity Service, Temple Street Children’s University Hospital, Temple Street, Dublin 1, Ireland

6 Paediatric Endocrinology, Temple Street Children’s University Hospital, Temple Street, Dublin 1, Ireland

7 Childhood Obesity Service, Physiotherapy Department, Temple Street Children’s University Hospital, Temple Street, Dublin 1, Ireland

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Trials 2014, 15:43  doi:10.1186/1745-6215-15-43

Published: 31 January 2014

Abstract

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/design

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.

Discussion

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.

Trial registration

Clinicaltrials.gov NCT01804855.

Keywords:
Obesity; Smartphone; Adolescent; Behavioural intervention; Mobile health; Telemedicine