search
Back to results

Effectiveness of a Smartphone App for Adolescent Obesity Management

Primary Purpose

Obesity, Impaired Health, Psychosocial Problem

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
W82GO
smartphone application
Sponsored by
Children's University Hospital, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity; mobile health; telemedicine; family-based treatment

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Temple Street Children's University Hospital
  • Temple Street Children's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

W82GO

Smartphone

Arm Description

Usual face-to-face care as per the W82GO multidisciplinary treatment intervention (phase 1 for 6 weeks and phase 2 for 46 weeks).

Usual care for Phase 1 of treatment. Treatment during Phase 2 of intervention using the Reactivate smartphone application only.

Outcomes

Primary Outcome Measures

BMI Z score
Z score calculated using LMS growth software

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2013
Last Updated
October 23, 2017
Sponsor
Children's University Hospital, Ireland
Collaborators
University College Cork, University of Oxford
search

1. Study Identification

Unique Protocol Identification Number
NCT01804855
Brief Title
Effectiveness of a Smartphone App for Adolescent Obesity Management
Official Title
An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's University Hospital, Ireland
Collaborators
University College Cork, University of Oxford

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Impaired Health, Psychosocial Problem, Physical Activity, General Nutrition Disorder
Keywords
Obesity; mobile health; telemedicine; family-based treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
W82GO
Arm Type
Active Comparator
Arm Description
Usual face-to-face care as per the W82GO multidisciplinary treatment intervention (phase 1 for 6 weeks and phase 2 for 46 weeks).
Arm Title
Smartphone
Arm Type
Experimental
Arm Description
Usual care for Phase 1 of treatment. Treatment during Phase 2 of intervention using the Reactivate smartphone application only.
Intervention Type
Behavioral
Intervention Name(s)
W82GO
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
smartphone application
Other Intervention Name(s)
Reactivate application
Intervention Description
Behavior change smartphone application for adolescents aiming to reduce obesity
Primary Outcome Measure Information:
Title
BMI Z score
Description
Z score calculated using LMS growth software
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Body Fat Mass
Description
Measured using Tanita Bioelectric impedance analyser
Time Frame
12 months
Title
Physical activity
Description
Measured using Geneactive acclerometery
Time Frame
12 months
Title
Laboratory tests
Description
Lipids; glucose; insulin; HbA1C; liver function
Time Frame
12 months
Title
Psychosocial health
Description
Measured using the Child Behaviour Check list
Time Frame
12 months
Title
Safety
Description
Adverse effects will be monitored throughout the study and a full report at 12 months will be given.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace O'Malley, MSc BSc
Organizational Affiliation
Temple Street Children's University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda Burls, MD, PhD
Organizational Affiliation
University of Oxford
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sinead Murphy, MD
Organizational Affiliation
Temple Street Children's University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ivan Perry, MD, PhD
Organizational Affiliation
University College Cork
Official's Role
Study Director
Facility Information:
Facility Name
Temple Street Children's University Hospital
City
Dublin
ZIP/Postal Code
Dublin 1
Country
Ireland
Facility Name
Temple Street Children's University Hospital
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Citations:
Citation
O'Malley G, Brinkley A, Moroney K, McInerney M, Murphy S, Kileen S, Murphy N. Establishing a hospital based obesity service: An Irish Experience. Obesity Facts 2012;5(S10):9.
Results Reference
background
Citation
O'Malley G, Brinkley A, Moroney K, McInerney M, Murphy S, Kileen S, Murphy N. Is the Temple Street W82Go Healthy Lifestyles Programme effective in reducing BMI SDS?. Obesity Facts 2012;5(S10):223
Results Reference
background
PubMed Identifier
34519665
Citation
Tully L, Sorensen J, O'Malley G. Pediatric Weight Management Through mHealth Compared to Face-to-Face Care: Cost Analysis of a Randomized Control Trial. JMIR Mhealth Uhealth. 2021 Sep 14;9(9):e31621. doi: 10.2196/31621.
Results Reference
derived
PubMed Identifier
24485327
Citation
O'Malley G, Clarke M, Burls A, Murphy S, Murphy N, Perry IJ. A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial. Trials. 2014 Jan 31;15:43. doi: 10.1186/1745-6215-15-43.
Results Reference
derived
Links:
URL
http://w82go.ie
Description
Website for W82GO programme and trial
URL
http://cuh.ie
Description
Website for Temple Street Children's University Hospital

Learn more about this trial

Effectiveness of a Smartphone App for Adolescent Obesity Management

We'll reach out to this number within 24 hrs