Effectiveness of a Smartphone App for Adolescent Obesity Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's University Hospital, Ireland
Sponsor:
Collaborators:
University College Cork
University of Oxford
Information provided by (Responsible Party):
Children's University Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT01804855
First received: March 4, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Obesity
Impaired Health
Psychosocial Problem
Physical Activity
General Nutrition Disorder
Behavioral: W82GO
Device: smartphone application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device

Resource links provided by NLM:


Further study details as provided by Children's University Hospital, Ireland:

Primary Outcome Measures:
  • BMI Z score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Z score calculated using LMS growth software


Secondary Outcome Measures:
  • Body Fat Mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured using Tanita Bioelectric impedance analyser

  • Physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured using Geneactive acclerometery

  • Laboratory tests [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Lipids; glucose; insulin; HbA1C; liver function

  • Psychosocial health [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured using the Child Behaviour Check list

  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse effects will be monitored throughout the study and a full report at 12 months will be given.


Estimated Enrollment: 126
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Reactivate application

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804855

Contacts
Contact: Grace O'Malley, MSc, Physio +353 1 878 ext 4563 grace.o'malley@cuh.ie
Contact: Sinead Murphy, MD +353 1 878 ext 4200 sinead.murphy@ucd.ie

Locations
Ireland
Temple Street Children's University Hospital Recruiting
Dublin, Ireland
Contact: Grace O'Malley, MSc BSc    +353 1 878 ext 4563    grace.o'malley@cuh.ie   
Principal Investigator: Grace O'Malley, MSc BSc         
Sub-Investigator: Sinead Murphy, MD         
Temple Street Children's University Hospital Recruiting
Dublin, Ireland, Dublin 1
Contact: Grace O'Malley, MSc Physiotherapy    353-1-878 ext 4563    grace.o'malley@cuh.ie   
Principal Investigator: Grace O'Malley, Msc Physio         
Sub-Investigator: Aoife Brinkley, PhD         
Sub-Investigator: Sinead Murphy, MD         
Sub-Investigator: Fiona Ward, BSc         
Sponsors and Collaborators
Children's University Hospital, Ireland
University College Cork
University of Oxford
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
  More Information

Additional Information:
No publications provided by Children's University Hospital, Ireland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's University Hospital, Ireland
ClinicalTrials.gov Identifier: NCT01804855     History of Changes
Other Study ID Numbers: TSCUH-2013-1158
Study First Received: March 4, 2013
Last Updated: August 11, 2014
Health Authority: Ireland: Health Service Executive
Ireland: Research Ethics Committee

Keywords provided by Children's University Hospital, Ireland:
Obesity; mobile health; telemedicine; family-based treatment

Additional relevant MeSH terms:
Obesity
Nutrition Disorders
Malnutrition
Pediatric Obesity
Overnutrition
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014