Clinical trial NCT01804855: Effectiveness of a Smartphone App for Adolescent Obesity Management
Official title: An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Impaired Health
Psychosocial Problem
Physical Activity
General Nutrition Disorder
Keywords: Obesity; mobile health; telemedicine; family-based treatment
Lead sponsor: Children's University Hospital, Ireland
Sponsor class: OTHER
Collaborators: name: University College Cork
name: University of Oxford
First posted: 2013-03-05
Enrollment: 126
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: BMI Z score
timeFrame: 12 months
Secondary outcomes:
measure: Body Fat Mass
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
measure: Laboratory tests
timeFrame: 12 months
measure: Psychosocial health
timeFrame: 12 months
measure: Safety
timeFrame: 12 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Temple Street Children's University Hospital
city: Dublin
country: Ireland
facility: Temple Street Children's University Hospital
Study officials:
affiliation: Temple Street Children's University Hospital
name: Grace O'Malley, MSc BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Amanda Burls, MD, PhD
role: STUDY_CHAIR
affiliation: Temple Street Children's University Hospital
name: Sinead Murphy, MD
role: STUDY_CHAIR
affiliation: University College Cork
name: Ivan Perry, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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
citation: Tully L, Sorensen J, O'Malley G. Pediatric Weight Management Through mHealth Compared to Face-to-Face Care: Cost Analysis of a Randomized Control Trial. JMIR Mhealth Uhealth. 2021 Sep 14;9(9):e31621. doi: 10.2196/31621.
citation: O'Malley G, Clarke M, Burls A, Murphy S, Murphy N, Perry IJ. A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial. Trials. 2014 Jan 31;15:43. doi: 10.1186/1745-6215-15-43.