Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000182594
Ethics application status
Approved
Date submitted
12/01/2015
Date registered
25/02/2015
Date last updated
26/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to examine the effectiveness of a novel technology based intervention to improve physical activity, sitting and sleep behaviours: the Balance study
Scientific title
A self-monitoring intervention in overweight adults aged 18-55 years aiming to increase physical activity and improve sedentary and sleep behaviours: the Balanced study
Secondary ID [1] 285939 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 293867 0
insufficient sleep 294025 0
Condition category
Condition code
Public Health 294172 294172 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study compares the effectiveness of a novel device-based self-monitoring intervention to improve adults’ physical activity, sedentary, and sleep-wake behaviours, compared with a user-entered self-monitoring intervention. The intervention used in this study, “Balance”, will be a freely available “app” that can be used on a mobile device (smartphone or tablet) with a self-monitoring device (device-measured (Fitbit); Group 1) or without one (user-entered; Group 2).
The proposed project will involve the development of a 2 arm intervention (Group 1: device (device-measured (Fitbit); Group 2: no device, user-entered) to engage participants in daily self-monitoring of physical activity, sitting and sleep-wake behaviours and to improve these behaviours. The intervention duration is 9 weeks and participants can access the intervention throughout the entire study period, both groups will be encouraged to engage in daily self-monitoring of behaviours. The proposed intervention may contribute to reducing levels of physical inactivity and insufficient sleep.
We aim to recruit a minimum of 64 adults aged 18-55 years from the Hunter Region, NSW, Australia. Participants will be low active, report frequent insufficient sleep and have a BMI between 18.5-35. It has been determined that a minimum of 32 participants per group would be required to detect statistically significant effects assuming a drop out of 35%.
Eligible participants will be asked to complete both physiological and survey based assessments at baseline, and 3 weeks, 6 weeks and 9 weeks post baseline. Participants will have access to the intervention throughout the entire study period and following the completion of the study.
Participants in both intervention groups will be able to self-monitor physical activity, sitting and sleep-wake behaviours, set goals for these behaviours, be provided with graphical feedback on their behaviour. Only the method of self-monitoring will differ, device measured or user-entered. In the device measured group, Fitbit data is automatically synchronized with the Balance platform via bluetooth and the internet (either wifi or phone network). Both groups will receive educational materials outlining the health effects of physical inactivity and insufficient sleep and strategies to assist in improving these behaviours.
Intervention code [1] 290917 0
Behaviour
Intervention code [2] 291034 0
Lifestyle
Comparator / control treatment
The comparison group is the user-entered group. Both intervention groups will have access to the intervention throughout the 9 week study period and will be encouraged to engage in daily self-monitoring.
Control group
Active

Outcomes
Primary outcome [1] 293963 0
minutes of moderate-to-vigorous intensity physical activity:assessed using GENEActiv at each time point by participants of both intervention groups. The GENEActiv is worn 24 hours per day for 8 days at each timepoint.
Timepoint [1] 293963 0
baseline, 3,6,9 weeks post baseline
Primary outcome [2] 294125 0
minutes of sedentary behaviour :assessed using GENEActiv at each time point by participants of both intervention groups. The GENEActiv is worn 24 hours per day for 8 days at each timepoint.
Timepoint [2] 294125 0
baseline, 3,6,9 weeks post baseline
Primary outcome [3] 294126 0
variation in sleep-wake patterns :assessed using GENEActiv at each time point by participants of both intervention groups. The GENEActiv is worn 24 hours per day for 8 days at each timepoint.
Timepoint [3] 294126 0
baseline, 3,6,9 weeks post baseline
Secondary outcome [1] 312239 0
Depression, Anxiety and Stress: Assessed using DASS-21 (Henry & Crawford (2005))
Timepoint [1] 312239 0
baseline, 3,6,9 weeks post baseline
Secondary outcome [2] 312240 0
Health related quality of life: assessed using Healthy Days instrument (Moriarty et al., (2003))
Timepoint [2] 312240 0
baseline, 3,6,9 weeks post baseline
Secondary outcome [3] 312241 0
sleep duration and quality: assessed PSQI (Buysse et al., (1989)
Timepoint [3] 312241 0
baseline, 3,6,9 weeks post baseline
Secondary outcome [4] 312242 0
Sleep Hygiene: assessed using Sleep Hygiene Index (Mastin et al., (2006)).
Timepoint [4] 312242 0
baseline, 3,6,9 weeks post baseline
Secondary outcome [5] 312244 0
Self-reported sleep timing: sleep timing questionnaire (Monk et al., (2003))
Timepoint [5] 312244 0
baseline, 3,6,9 weeks post baseline
Secondary outcome [6] 312245 0
Self-reported sitting time: Assessed using Workforce Sitting Questionnaire (Chau et al., (2011))
Timepoint [6] 312245 0
baseline, 3,6,9 weeks post baseline
Secondary outcome [7] 312246 0
Self-reported physical activity: assessed using Active Australia Questionnaire
Timepoint [7] 312246 0
baseline, 3,6,9 weeks post baseline
Secondary outcome [8] 312247 0
psychosocial correlates of sleep, physical activity and sitting: assessed using items based on (Dewar, et al., (2012); Dewar, et al., (2013))
Timepoint [8] 312247 0
baseline, 3,6,9 weeks post baseline
Secondary outcome [9] 312577 0
Sleep Sufficiency: assessed using the CDC/BRFSS sleep module
Timepoint [9] 312577 0
baseline, 3,6,9 weeks post baseline

Eligibility
Key inclusion criteria
BMI between 18.5-35,
perform less than 30 minutes of moderate to vigorous intensity activity per week,
spend at least 8 hours per day sitting,
report waking up not feeling rested/needed more sleep on 14 or more days in last 30,
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
have a condition making it unsafe for them to change their activity, sitting and sleep behaviours,
have a condition meaning that can't increase activity level,
have an existing sleep disorder (e.g. insominia, sleep aponea, restless legs syndrome),
taking medication to induce sleep,
engaged in shift work,
are currently using an app or activity tracker to self-monitor activity and/or sleep behaviours.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via recruit posters distributed at University of Newcastle Callaghan campus, local businesses, community notice boards (both physical and electronically), community events (e.g., relay for life, bike for life) and via electronic communication (PRC-PAN email lists, social media profiles of PRC-PAN and researchers, University associated participant registries, email and promotions).
Interested participants will be asked to visit a website where they will complete a online screening questionnaire to assess eligibility.

Eligible participants will be invited to attend a baseline assessment session at the University of Newcastle, Callaghan campus. At this session the study purpose, requirements will be described to participants, consent will be obtained, and participants will be provided with a GENEActiv monitor to wear for 8 days. After this participants will return to University to return the GENEActiv, complete surveys instruments and have physiological assessments completed. Following the completion of these assessments participants will be randomized to a intervention group, have the app installed on their device and if allocated to the device-entered group be provided with a Fitbit.
Randomisation will occur using a computer-based random number generator. The sequence will be generated by a researcher not involved in participant assessments and will be stored on a central database not accessible to those completing the assessments. Group allocations will be concealed in sequentially numbered opaque envelopes which will be distributed to participants by a researcher not involved in the assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once baseline testing has been completed, participants will be randomly allocated to one of the two study groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will test for between-group differences across the study time points: 3-weeks, 6-weeks, and 9-weeks using separate linear mixed models for primary and secondary outcomes, with fixed effects for treatment group (user-entered vs device) time (baseline, W3, W6 and W9) and their interaction. The analysis will be conducted using STATA and alpha will be set at <0.05. Sample size was determined assuming a correlation of 0.6 between repeated measures, 80% power, and a group by time interaction for each of the five primary outcome variables, at the 1% significance threshold, and differences between groups of 30 minutes of physical activity, 90 minutes of sedentary behaviour, 30 minutes in sleep variation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/03/2015
Actual
23/07/2015
Date of last participant enrolment
Anticipated
15/04/2016
Actual
15/03/2016
Date of last data collection
Anticipated
Actual
7/11/2016
Sample size
Target
64
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290525 0
University
Name [1] 290525 0
University of Newcastle
Country [1] 290525 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Heart Foundation of Australia
Address
Level 12, 500 Collins Street, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 289220 0
Individual
Name [1] 289220 0
Dr Mitch Duncan
Address [1] 289220 0
School of Medicine & Public Health, Priority Research Centre for Physical Activity and Nutrition
Faculty of Health and Medicine
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country [1] 289220 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292174 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 292174 0
Research Services
Research Office
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Ethics committee country [1] 292174 0
Australia
Date submitted for ethics approval [1] 292174 0
Approval date [1] 292174 0
08/12/2014
Ethics approval number [1] 292174 0
H-2014-0336

Summary
Brief summary
The purpose of Balanced project is to examine the feasibility of a mobile device intervention, Balanced, to improve the physical activity and sleep behaviours of Australian adults (aged 18-55). Balanced will allow participants to keep track of their sitting, physical activity and sleep behaviours each day and will encourage them to make changes to daily routines to improve these behaviours.

Following recruitment and completion of baseline assessments participants will be randomly allocated to one of two intervention groups. One group will be asked to wear an activity tracker on their wrist which will record daily activities, participants will be asked to return this monitor at the end of the study; the second group will be asked to recall and record their activities each day.

Participants will complete follow-up assessments at 3,6 and 9 weeks post baseline assessment. Objective measures of behaviour and cardiometabolic risk will be assessed in addition to self-report measures of behaviour, physical and mental well-being and correlates of activity, sitting and sleep behaviours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53906 0
Dr Mitch Duncan
Address 53906 0
School of Medicine & Public Health, Priority Research Centre for Physical Activity and Nutrition
Faculty of Health and Medicine
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country 53906 0
Australia
Phone 53906 0
+61 02 49215215
Fax 53906 0
Email 53906 0
Mitch.Duncan@newcastle.edu.au
Contact person for public queries
Name 53907 0
Dr Mitch Duncan
Address 53907 0
School of Medicine & Public Health, Priority Research Centre for Physical Activity and Nutrition
Faculty of Health and Medicine
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country 53907 0
Australia
Phone 53907 0
+61 02 49215215
Fax 53907 0
Email 53907 0
Mitch.Duncan@newcastle.edu.au
Contact person for scientific queries
Name 53908 0
Dr Mitch Duncan
Address 53908 0
School of Medicine & Public Health, Priority Research Centre for Physical Activity and Nutrition
Faculty of Health and Medicine
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country 53908 0
Australia
Phone 53908 0
+61 02 49215215
Fax 53908 0
Email 53908 0
Mitch.Duncan@newcastle.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.