NCT01804855

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

4.3 years

First QC Date

March 4, 2013

Last Update Submit

October 23, 2017

Conditions

ObesityImpaired HealthPsychosocial ProblemPhysical ActivityGeneral Nutrition Disorder

Keywords

Obesity; mobile health; telemedicine; family-based treatment

Outcome Measures

Primary Outcomes (1)

  • BMI Z score

    Z score calculated using LMS growth software

    12 months

Secondary Outcomes (5)

  • Body Fat Mass

    12 months

  • Physical activity

    12 months

  • Laboratory tests

    12 months

  • Psychosocial health

    12 months

  • Safety

    12 months

Study Arms (2)

W82GO

ACTIVE COMPARATOR

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

Smartphone

EXPERIMENTAL

Usual care for Phase 1 of treatment. Treatment during Phase 2 of intervention using the Reactivate smartphone application only.

Device: smartphone application

Interventions

W82GOBEHAVIORAL

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

W82GO
smartphone applicationDEVICE

Behavior change smartphone application for adolescents aiming to reduce obesity

Also known as: Reactivate application
Smartphone

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Temple Street Children's University Hospital

Dublin, Dublin 1, Ireland

Location

Temple Street Children's University Hospital

Dublin, Ireland

Location

Related Publications (4)

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 34519665DERIVED

  • 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.

    PMID: 24485327DERIVED

Related Links

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Grace O'Malley, MSc BSc

    Temple Street Children's University Hospital

    PRINCIPAL INVESTIGATOR

  • Amanda Burls, MD, PhD

    University of Oxford

    STUDY CHAIR

  • Sinead Murphy, MD

    Temple Street Children's University Hospital

    STUDY CHAIR

  • Ivan Perry, MD, PhD

    University College Cork

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 5, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

IE(2)