Obesity Clinical Trial
Official title:
An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device
Verified date | October 2017 |
Source | Children's University Hospital, Ireland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Ireland | Temple Street Children's University Hospital | Dublin | |
Ireland | Temple Street Children's University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
Children's University Hospital, Ireland | University College Cork, University of Oxford |
Ireland,
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
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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