Effectiveness of a Smartphone App for Adolescent Obesity Management

Sponsor
Children's University Hospital, Ireland (Other)
Overall Status
Unknown status
CT.gov ID
NCT01804855
Collaborator
University College Cork (Other), University of Oxford (Other)
126
2
2
63.9
63
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: W82GO
  • Device: smartphone application
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device
Actual Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. BMI Z score [12 months]

      Z score calculated using LMS growth software

    Secondary Outcome Measures

    1. Body Fat Mass [12 months]

      Measured using Tanita Bioelectric impedance analyser

    2. Physical activity [12 months]

      Measured using Geneactive acclerometery

    3. Laboratory tests [12 months]

      Lipids; glucose; insulin; HbA1C; liver function

    4. Psychosocial health [12 months]

      Measured using the Child Behaviour Check list

    5. Safety [12 months]

      Adverse effects will be monitored throughout the study and a full report at 12 months will be given.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Temple Street Children's University Hospital Dublin Ireland Dublin 1
    2 Temple Street Children's University Hospital Dublin Ireland

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Children's University Hospital, Ireland
    ClinicalTrials.gov Identifier:
    NCT01804855
    Other Study ID Numbers:
    • TSCUH-2013-1158
    First Posted:
    Mar 5, 2013
    Last Update Posted:
    Oct 25, 2017
    Last Verified:
    Oct 1, 2017
    Keywords provided by Children's University Hospital, Ireland
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 25, 2017