Effectiveness of a Smartphone App for Adolescent Obesity Management

Study Overview
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Brief Summary
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Though face-to-face treatment of childhood obesity can be effective, it is time consuming and costly. This study will test whether treatment can be delivered via an Android app and whether such treatment reduces obesity.

Official Title
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An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device

Conditions
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Impaired Health, Obesity, Psychosocial Problem, Physical Activity, General Nutrition Disorder

Intervention / Treatment
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* Behavioral: W82GO
* Device: smartphone application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child aged between 12.0 and 17.0 years, child BMI =/> 98th percentile, first language is English (or fluent in English) parent/s willing to participate in the programme with their child completion of written informed consent and/or assent prior to any study-specific procedures Exclusion Criteria: severe intellectual difficulties, obesity secondary to genetic condition, limitations to engaging in physical activity use of medication known to effect body weight; limitations to using a smartphone device known family issues that would affect general compliance and attendance at follow-up visits.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: W82GO<br>Usual face-to-face care as per the W82GO multidisciplinary treatment intervention (phase 1 for 6 weeks and phase 2 for 46 weeks). | Behavioral: W82GO<br>* MDT delivered obesity intervention integrating behavioural change methods in order to reduce obesity; improve nutrition; increase physical activity; improve sleep; reduce sedentarism and increase self-esteem<br>|
| Experimental: Smartphone<br>Usual care for Phase 1 of treatment. Treatment during Phase 2 of intervention using the Reactivate smartphone application only. | Device: smartphone application<br>* Behavior change smartphone application for adolescents aiming to reduce obesity<br>* Other names: Reactivate application;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI Z score | Z score calculated using LMS growth software | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Fat Mass | Measured using Tanita Bioelectric impedance analyser | 12 months | 
| Physical activity | Measured using Geneactive acclerometery | 12 months | 
| Laboratory tests | Lipids; glucose; insulin; HbA1C; liver function | 12 months | 
| Psychosocial health | Measured using the Child Behaviour Check list | 12 months | 
| Safety | Adverse effects will be monitored throughout the study and a full report at 12 months will be given. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity; mobile health; telemedicine; family-based treatment