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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01804855
Other study ID # TSCUH-2013-1158
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 4, 2013
Last updated October 23, 2017
Start date February 2013
Est. completion date June 2018

Study information

Verified date October 2017
Source Children's University Hospital, Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 126
Est. completion date June 2018
Est. primary completion date June 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 17 Years
Eligibility 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.

Study Design


Intervention

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
Device:
smartphone application
Behavior change smartphone application for adolescents aiming to reduce obesity

Locations

Country Name City State
Ireland Temple Street Children's University Hospital Dublin
Ireland Temple Street Children's University Hospital Dublin

Sponsors (3)

Lead Sponsor Collaborator
Children's University Hospital, Ireland University College Cork, University of Oxford

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

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

Outcome

Type Measure Description Time frame Safety issue
Primary BMI Z score Z score calculated using LMS growth software 12 months
Secondary Body Fat Mass Measured using Tanita Bioelectric impedance analyser 12 months
Secondary Physical activity Measured using Geneactive acclerometery 12 months
Secondary Laboratory tests Lipids; glucose; insulin; HbA1C; liver function 12 months
Secondary Psychosocial health Measured using the Child Behaviour Check list 12 months
Secondary Safety Adverse effects will be monitored throughout the study and a full report at 12 months will be given. 12 months
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