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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000182594
• Date of registration: 25/02/2015
• Prospective Registration: Yes
• Primary sponsor: National Heart Foundation of Australia
• 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
• Date of first enrolment: 23/07/2015
• Target sample size: 64
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000182594.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Mitch Duncan

• Name: Dr Mitch Duncan

Key inclusion & exclusion criteria

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,
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.

Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

physical inactivity;insufficient sleep;
physical inactivity
insufficient sleep

Public Health - Health promotion/education

Intervention(s)

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 physica

Primary Outcome(s)

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.[baseline, 3,6,9 weeks post baseline]

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.[baseline, 3,6,9 weeks post baseline ]

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.[baseline, 3,6,9 weeks post baseline]

Secondary Outcome(s)

Self-reported sitting time: Assessed using Workforce Sitting Questionnaire (Chau et al., (2011))[baseline, 3,6,9 weeks post baseline ]

Sleep Hygiene: assessed using Sleep Hygiene Index (Mastin et al., (2006)).[baseline, 3,6,9 weeks post baseline ]

Self-reported physical activity: assessed using Active Australia Questionnaire[baseline, 3,6,9 weeks post baseline ]

Depression, Anxiety and Stress: Assessed using DASS-21 (Henry & Crawford (2005))[baseline, 3,6,9 weeks post baseline ]

sleep duration and quality: assessed PSQI (Buysse et al., (1989)[baseline, 3,6,9 weeks post baseline ]

Health related quality of life: assessed using Healthy Days instrument (Moriarty et al., (2003))[baseline, 3,6,9 weeks post baseline ]

psychosocial correlates of sleep, physical activity and sitting: assessed using items based on (Dewar, et al., (2012); Dewar, et al., (2013))[baseline, 3,6,9 weeks post baseline ]

Self-reported sleep timing: sleep timing questionnaire (Monk et al., (2003))[baseline, 3,6,9 weeks post baseline ]

Sleep Sufficiency: assessed using the CDC/BRFSS sleep module[baseline, 3,6,9 weeks post baseline]

Secondary ID(s)

Nil

Source(s) of Monetary Support

University of Newcastle

Secondary Sponsor(s)

Dr Mitch Duncan

Ethics review

Status: Approved
Approval date:
Contact:

University of Newcastle Human Research Ethics Committee