ObesityNCT01804855
Effectiveness of a Smartphone App for Adolescent Obesity Management
A study testing W82GO and smartphone application in people with Obesity and Impaired Health, run by Children's University Hospital, Ireland at 2 sites in Ireland.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Impaired Health, Psychosocial Problem
- What is being tested?
- W82GO and smartphone application
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesIreland
- Study dates
- Feb 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Temple Street Children's University Hospital
Dublin, Dublin 1
Temple Street Children's University Hospital
Dublin
About this study
Official title: An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device
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.
- Conditions
- Obesity, Impaired Health, Psychosocial Problem, Physical Activity, General Nutrition Disorder
- Being tested
- W82GO, smartphone application
- Keywords
- Obesity; mobile health; telemedicine; family-based treatment
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W82GOBehavioural
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
smartphone applicationDevice
Also called Reactivate application
Behavior change smartphone application for adolescents aiming to reduce obesity
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: W82GO |
| Smartphone | Experimental | Usual care for Phase 1 of treatment. Treatment during Phase 2 of intervention using the Reactivate smartphone application only. Receives: Device: smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Z score
Z score calculated using LMS growth software
Measured: 12 months
Secondary outcomes (5)
Body Fat Mass
Measured using Tanita Bioelectric impedance analyser
Measured: 12 months
Physical activity
Measured using Geneactive acclerometery
Measured: 12 months
Laboratory tests
Lipids; glucose; insulin; HbA1C; liver function
Measured: 12 months
Psychosocial health
Measured using the Child Behaviour Check list
Measured: 12 months
Safety
Adverse effects will be monitored throughout the study and a full report at 12 months will be given.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completion1 Jun 2017
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Grace O'Malley, MSc BSc, Principal investigator, Temple Street Children's University HospitalAmanda Burls, MD, PhD, Study chair, University of OxfordSinead Murphy, MD, Study chair, Temple Street Children's University HospitalIvan Perry, MD, PhD, Study director, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804855
- Sponsor's protocol ID
- TSCUH-2013-1158
- Status last verified
- Oct 2017
- First submitted
- 4 Mar 2013
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
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
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.
PubMed 34519665O'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.
PubMed 24485327
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device
- ClinicalTrials.gov ID
- NCT01804855
- Acronym / sponsor ID
- TSCUH-2013-1158
- Conditions
- Obesity, Impaired Health, Psychosocial Problem, Physical Activity, General Nutrition Disorder
- Keywords
- Obesity; mobile health; telemedicine; family-based treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Children's University Hospital, IrelandUniversity, hospital or other
- Collaborators
- University College Cork, University of Oxford
- Study start
- Feb 2013 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| W82GO | Active comparator | Behavioral: W82GOUsual face-to-face care as per the W82GO multidisciplinary treatment intervention (phase 1 for 6 weeks and phase 2 for 46 weeks). |
| Smartphone | Experimental | Device: smartphone applicationUsual care for Phase 1 of treatment. Treatment during Phase 2 of intervention using the Reactivate smartphone application only. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| W82GOMDT 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 | Behavioural | W82GO |
| smartphone applicationAlso: Reactivate applicationBehavior change smartphone application for adolescents aiming to reduce obesity | Device | Smartphone |
Primary outcome
BMI Z score
Time frame: 12 months
Z score calculated using LMS growth software
5 secondary outcomes
Body Fat Mass
Time frame: 12 months
Physical activity
Time frame: 12 months
Laboratory tests
Time frame: 12 months
Psychosocial health
Time frame: 12 months
Safety
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- BackgroundO'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.
- BackgroundO'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
- Derived from this study: PubMed 34519665Tully 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.
- Derived from this study: PubMed 24485327O'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.
- Website for W82GO programme and trialLink provided by the sponsor.
- Website for Temple Street Children's University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace O'Malley, MSc BSc principal investigator
Temple Street Children's University Hospital
Amanda Burls, MD, PhD study chair
University of Oxford
Sinead Murphy, MD study chair
Temple Street Children's University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing W82GO and smartphone application in people with Obesity and Impaired Health, run by Children's University Hospital, Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI Z score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01804855, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.