Effectiveness of the Reactivate App for Adolescent Obesity Management

This study is currently recruiting participants.
Verified March 2013 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: NA
Last verified: March 2013
History: No changes posted
  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
Adolescent Obesity
Metabolic 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 ]

Secondary Outcome Measures:
  • Body Fat [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ]
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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 programme
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: Reactivate
Treatment using the Reactivate smartphone application
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01804855

Contacts
Contact: Grace O'Malley, MSc, Physiotherapy +353 1 878 ext 4563 grace.o'malley@cuh.ie

Locations
Ireland
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 Physiotherapy         
Sub-Investigator: Aoife Brinkley, PhD         
Sub-Investigator: Sinead Murphy, MD         
Sub-Investigator: Fiona Ward, BSc Nutrition and Dietetics         
Sponsors and Collaborators
Children's University Hospital, Ireland
University College Cork
University of Oxford
Investigators
Principal Investigator: Grace O'Malley, MSc Physiotherapy 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

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: March 4, 2013
Health Authority: Ireland: Health Service Executive
Ireland: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 14, 2014