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Effectiveness of a Smartphone App for Adolescent Obesity Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01804855
Recruitment Status : Unknown
Verified October 2017 by Children's University Hospital, Ireland.
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2013
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
University College Cork
University of Oxford
Information provided by (Responsible Party):
Children's University Hospital, Ireland

Study Description
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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
Obesity Impaired Health Psychosocial Problem Physical Activity General Nutrition Disorder Behavioral: W82GO Device: smartphone application Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2013
Actual Primary Completion Date : June 1, 2017
Estimated Study Completion Date : June 2018
Arms and Interventions
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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 Name: Reactivate application


Outcome Measures
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Primary Outcome Measures :
  1. BMI Z score [ Time Frame: 12 months ]
    Z score calculated using LMS growth software


Secondary Outcome Measures :
  1. Body Fat Mass [ Time Frame: 12 months ]
    Measured using Tanita Bioelectric impedance analyser

  2. Physical activity [ Time Frame: 12 months ]
    Measured using Geneactive acclerometery

  3. Laboratory tests [ Time Frame: 12 months ]
    Lipids; glucose; insulin; HbA1C; liver function

  4. Psychosocial health [ Time Frame: 12 months ]
    Measured using the Child Behaviour Check list

  5. Safety [ Time Frame: 12 months ]
    Adverse effects will be monitored throughout the study and a full report at 12 months will be given.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804855


Locations
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Ireland
Temple Street Children's University Hospital
Dublin, Ireland, Dublin 1
Temple Street Children's University Hospital
Dublin, Ireland
Sponsors and Collaborators
Children's University Hospital, Ireland
University College Cork
University of Oxford
Investigators
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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
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Additional Information:

Publications:
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.
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's University Hospital, Ireland
ClinicalTrials.gov Identifier: NCT01804855    
Other Study ID Numbers: TSCUH-2013-1158
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Keywords provided by Children's University Hospital, Ireland:
Obesity; mobile health; telemedicine; family-based treatment
Additional relevant MeSH terms:
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Obesity
Nutrition Disorders
Overweight
Overnutrition
Body Weight