Effectiveness of a Smartphone App for Adolescent Obesity Management

October 23, 2017 updated by: Children's University Hospital, Ireland

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • Temple Street Children's University Hospital
      • Dublin, Ireland, Dublin 1
        • Temple Street Children's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: W82GO
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
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
EXPERIMENTAL: Smartphone
Usual care for Phase 1 of treatment. Treatment during Phase 2 of intervention using the Reactivate smartphone application only.
Device: smartphone application
Behavior change smartphone application for adolescents aiming to reduce obesity
Other Names:
  • Reactivate application

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's University Hospital, Ireland

Collaborators

University of Oxford
University College Cork

Investigators

  • Principal Investigator: Grace O'Malley, MSc BSc, Temple Street Children's University Hospital
  • Study Chair: Amanda Burls, MD, PhD, University of Oxford
  • Study Chair: Sinead Murphy, MD, Temple Street Children's University Hospital
  • Study Director: Ivan Perry, MD, PhD, University College Cork

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2013

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (ESTIMATE)

March 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSCUH-2013-1158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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