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Trial registered on ANZCTR


Registration number
ACTRN12615001073594
Ethics application status
Approved
Date submitted
10/09/2015
Date registered
13/10/2015
Date last updated
19/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Keeping track of your health: an evaluation trial of UBWELL for improving the health and wellbeing of young people
Scientific title
Does a smart-phone app-based real-time continuous data tracker help to improve the health and wellbeing of young people as compared to other smart-phone apps that regulate sleep or provide health information?
Secondary ID [1] 287431 0
Nil
Universal Trial Number (UTN)
U1111-1174-2406
Trial acronym
UBWELL_1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 296146 0
Condition category
Condition code
Mental Health 296419 296419 0 0
Depression
Mental Health 296420 296420 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
UBWELL is a smart-phone application (i.e. app) that delivers a series of health related questions (mood, anxiety, energy, sleep, alcohol use, functional engagement, social interaction, technology use) at multiple time points throughout the day (up to 4). The information collected throughout the day (and over time) are presented back to the users on dynamic graphs that provide users with the opportunity to see how these analytics relate to each other and vary over time. The overall duration of the intervention is 6 weeks, and adherence to the intervention will be assessed at the end of 6 week trial using a self report questionnaire.
Intervention code [1] 292793 0
Behaviour
Comparator / control treatment
Two other smart-phone based apps have been employed as comparators. The first comparator is 'Recharge' which is an app-based intervention targeting the regulation of the sleep/wake cycle. The second comparator is Ozhealth, which is an app that provides health information only.
Control group
Active

Outcomes
Primary outcome [1] 296051 0
Percentage (%) change in three items measuring general health and wellbeing:
How would you rate your overall health?
(5 point likert scale response "very bad" to "very good")
Timepoint [1] 296051 0
Baseline and post-intervention (6 weeks)
Primary outcome [2] 296251 0
Percentage (%) change in three items measuring general health and wellbeing:
How would you rate your overall physical health?
(5 point likert scale response "very bad" to "very good")
Timepoint [2] 296251 0
Baseline and post-intervention (6 weeks)
Primary outcome [3] 296252 0
Percentage (%) change in three items measuring general health and wellbeing:
How would you rate your overall mental health?
(5 point likert scale response "very bad" to "very good")
Timepoint [3] 296252 0
Baseline and post-intervention (6 weeks)
Secondary outcome [1] 317358 0
Percentage (%) change over time as measured on analytics including:
- Mental health - 12-item Somatic and Psychological Health Report (SPHERE-12); 10-item Kessler Psychological Distress Scale (K-10); and, disability as per Brief Disability "days out of role" (note: disability is measured via mean change over time).
Timepoint [1] 317358 0
Measured at 3 months, 6 months and 12 months (if an effect is detected at 6 months).
Secondary outcome [2] 317978 0
Percentage (%) change over time as measured on analytics including:
- Tobacco and alcohol use - including items measuring behavioural change over the past 6 weeks/ 3 months.
Timepoint [2] 317978 0
Measured at 3 months, 6 months and 12 months (if an effect is detected at 6 months).
Secondary outcome [3] 317979 0
Percentage (%) change over time as measured on analytics including:
- Physical activity - vigorous, moderate, walking and sitting as per the short-form International Physical Activity Questionnaire.
Timepoint [3] 317979 0
Measured at 3 months, 6 months and 12 months (if an effect is detected at 6 months).
Secondary outcome [4] 317980 0
Percentage (%) change over time as measured on analytics including:
- Sleep/ wake cycle behaviour - including time to bed, time wake up, description of sleep behaviour in the past week.
Timepoint [4] 317980 0
Measured at 3 months, 6 months and 12 months (if an effect is detected at 6 months).
Secondary outcome [5] 317981 0
Percentage (%) change over time as measured on analytics including:
- Eating behaviours - including typical diet over the past week and body image over the past 6 weeks/ 3 months.
Timepoint [5] 317981 0
Measured at 3 months, 6 months and 12 months (if an effect is detected at 6 months).
Secondary outcome [6] 317982 0
Percentage (%) change over time as measured on analytics including:
- Social networking - including items about the respondents relationships with people close to them as well as their social network
Timepoint [6] 317982 0
Measured at 3 months, 6 months and 12 months (if an effect is detected at 6 months).

Eligibility
Key inclusion criteria
1. Aged 16 to 30 years
2. Not currently receiving care from a psychiatrist or a psychologist
3. Has regular access (daily) to the Internet via an iPhone (iOS 8 or later)
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residing outside of Australia

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be assessed for inclusion into the study by a computer. Those who meet the inclusion criteria will be automatically randomised to the experimental or control conditions using a simple computer-generated randomisation sequence following completion of consent procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Randomisation will also be stratified by age (16 to 24 years; 25 to 30 years), gender (males, females) and location (metropolitan, regional, rural/ remote).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome measures include percentage change in participant perception of overall health, overall physical health and overall mental health during the course of the study.

Primary statistical analysis will be conducted with all participants
who complete randomisation. Mixed models repeated measures ANOVA, with measurement occasion as a within groups factor and intervention condition as a between groups factor will be used to examine primary measures of outcome. Planned contrasts will be used to compare intervention and control groups immediately post intervention and at 3-months, 6-months (and 12-month) follow-up. Logistic and linear regressions will be used to examine differences between conditions on baseline variables, and logistic regressions will be used to assess the effect of the intervention on participant dropout as well as to investigate predictors of missingness (completers/ non-completers) post intervention and at followup.

Power analysis
A power analysis indicated that a total sample of 159 people would be needed to detect medium to large effects (eta squared = 0.25), with 80% power and alpha at .05.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/02/2017
Actual
Date of last participant enrolment
Anticipated
5/02/2018
Actual
Date of last data collection
Anticipated
7/05/2018
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292006 0
Charities/Societies/Foundations
Name [1] 292006 0
The Australian Foundation for Mental Health Research (AFFIRM)
Country [1] 292006 0
Australia
Primary sponsor type
Individual
Name
Professor Ian Hickie
Address
Brain and Mind Centre
The University of Sydney
94 Mallett Street
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 290674 0
Individual
Name [1] 290674 0
Tracey Davenport
Address [1] 290674 0
Brain and Mind Centre
The University of Sydney
100 Mallett Street
Camperdown NSW 2050
Country [1] 290674 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293494 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 293494 0
Ethics committee country [1] 293494 0
Australia
Date submitted for ethics approval [1] 293494 0
18/05/2015
Approval date [1] 293494 0
14/09/2015
Ethics approval number [1] 293494 0
2015/457

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60138 0
Prof Ian Hickie
Address 60138 0
Brain and Mind Centre
The University of Sydney
94 Mallett Street
Camperdown NSW 2050
Country 60138 0
Australia
Phone 60138 0
+61 2 9351 0810
Fax 60138 0
Email 60138 0
ian.hickie@sydney.edu.au
Contact person for public queries
Name 60139 0
Tracey Davenport
Address 60139 0
Brain and Mind Centre
The University of Sydney
100 Mallett Street
Camperdown NSW 2050
Country 60139 0
Australia
Phone 60139 0
+61 2 9351 0827
Fax 60139 0
Email 60139 0
tracey.davenport@sydney.edu.au
Contact person for scientific queries
Name 60140 0
Tracey Davenport
Address 60140 0
Brain and Mind Centre
The University of Sydney
100 Mallett Street
Camperdown NSW 2050
Country 60140 0
Australia
Phone 60140 0
+61 2 9351 0827
Fax 60140 0
Email 60140 0
tracey.davenport@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.