Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000543482p
Ethics application status
Submitted, not yet approved
Date submitted
15/04/2025
Date registered
28/05/2025
Date last updated
28/05/2025
Date data sharing statement initially provided
28/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Walking And Thriving for Community Health (WATCH) study: Can digital health prompts boost daily physical activity in adults?
Scientific title
Walking And Thriving for Community Health (WATCH) study: Can digital health prompts boost daily physical activity in adults?
Secondary ID [1] 314114 0
Nil known
Universal Trial Number (UTN)
U1111-1321-2646
Trial acronym
WATCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary lifestyles 337042 0
Physical Inactivity 337214 0
Condition category
Condition code
Public Health 333489 333489 0 0
Health promotion/education
Cardiovascular 333624 333624 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A three-arm randomised controlled trial will be conducted using digital health technologies, a mobile application and a smartwatch—in a free-living environment. The trial will target members of St. Lukes Health insurance, aiming to evaluate the effectiveness of behavioural change prompts in promoting sustained increases in daily walking. Participants, aged 18 to 74 years, will use the Snug Health app synced with a Garmin smartwatch to track and monitor their daily movement.
Two experimental groups (synergy and single BCT group) will receive daily prompts delivered through the digital health-system based on their previous 60-minute inactivity status, whereas the control group will not receive any prompts to engage in daily movement habits. If there is no activity detected for the past 60 minutes, an automatic prompt will be sent to participants’ smartwatch through the Snug Health app in both experimental groups. The smartwatch will track inactivity status and upload this information to the cloud server, which will then relay it to the Snug Health app. Based on the participant’s assigned group, the Snug Health app will generate a prompt, send it back to the cloud server, and finally deliver it to the participant’s smartwatch as a reminder. Control participants will only receive notifications at the end of each day to charge their watch and to wear it for > 8 hours/day. Participants will wear their smart watch for 12 weeks that will include a 6-week intervention period. We will objectively track the primary outcome variable (participant weekly step counts) throughout the study. These data will be analysed through 15-minute epochs of wear time.
For the synergy group five synergistic behaviour change techniques will be delivered to the participants’ smartwatch across a sequential five-day pattern. The sequence will start on Monday with goal setting, action planning (Tuesday), self-monitoring (Wednesday), information about health consequences (Thursday) and end on Friday with self-talk. For example, the synergy group will receive a goal setting prompt on Monday to ‘Set a weekly step goal’. This goal will be recorded in the Snug Health app and used as a benchmark for progress through the rest of the week. Each prompt will target a different phase of behaviour change based on the Health Action Process Approach (HAPA) model (Bohlen et al., 2020). This model initiates risk perception at the motivational phase leading to the formation of an intention (the decision to start exercising). We selected BCTs to enhance participant motivation such as ‘goal setting’ and 'information about health consequences', and to translate intention into action (taking steps) such as ‘action planning’ and ‘self-talk’. This synergistic approach reflects a shared implicit understanding of an additive relationship between intervention techniques and their combined effectiveness to elicit behaviour change, as demonstrated by previous studies (Parkinson et al., 2023; Schwarzer, 2016).
The single BCT group will also have their steps tracked through the digital health system, and if there has been no activity (steps) for the last 60 minutes a single prompt (Be active! It is time to move) will be delivered. This single prompt will be delivered throughout the intervention period so we can test the effectiveness of the synergy group strategy. Adherence to the wearing the smartwatch will be initially monitored daily during the three-week onboarding phase. Participants who fail to wear their smartwatch for at least 8 hours per day most days per week during this phase will be reminded of this requirement through the Snug Health app and if the behaviour persists will be excluded before the intervention phase begins. Adherence to the intervention will be measured weekly by monitoring the 15-minute epoch steps data produced by the smartwatch.
This study is designed to assess the impact of these digital health interventions on walking behaviour over time, offering valuable insights into the effectiveness of digital health tools in promoting physical activity among health insured members in real-world settings. The findings will contribute to the broader understanding of how digital health interventions can support long-term behavioural change and inform future health promotion strategies.
Intervention code [1] 330786 0
Lifestyle
Intervention code [2] 330787 0
Behaviour
Comparator / control treatment
Randomly allocated control participants will wear a smartwatch during the intervention period to only track their movement, without receiving any prompts to do so.
Control group
Active

Outcomes
Primary outcome [1] 341070 0
Step count
Timepoint [1] 341070 0
Continuously measured over the 12-week period: Step counts will be measured over three weeks before the intervention begins to establish a baseline. Step counts will be continuously measured during the six week intervention period, and during the three week washout period.
Secondary outcome [1] 446041 0
Quality of life
Timepoint [1] 446041 0
Baseline, post 6-week intervention
Secondary outcome [2] 446042 0
Exercise-related self-efficacy
Timepoint [2] 446042 0
Baseline, post 6-week intervention
Secondary outcome [3] 446043 0
Digital health technology engagement and functionality will be assessed as a composite outcome
Timepoint [3] 446043 0
On the 12th (and final) week of the study

Eligibility
Key inclusion criteria
St. Lukes Health member
Aged 18-74 years
Owns and uses a smartphone (Android or iOS)
Willing to use the Garmin smartwatch and Snug Health app for the duration of the study
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Doctors' advice is to not participate in studies that require physical movement.
This will be determined by having volunteers first complete the Physical Activity Readiness Questionnaire before enrolling in the study.

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)
Central randomisation by computer performed independently of research team
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Baseline differences in step count between groups will be compared using analysis of variance (ANOVA). Repeated measures within and between groups in step count (average step count per week) will be examined using Mixed Model ANOVA along the progress of the RCT. Additionally, Cohen’s d (Cohen, 2013) will be used to calculate the effect size for each pairwise comparison among the three groups. To examine the effectiveness of the intervention and to avoid bias (e.g. if withdrawal from the intervention is associated with the outcome), analysis will be conducted based on the intention to-treat principle. Substituting baseline data will be done for those at the post intervention period for dropout or noncompliance participants during the intervention (Tully et al., 2007).
For quality of life, Physical Component Summary (PCS) score and Mental Component Summary (MCS) score will be evaluated. Mixed design ANOVAs will be used to measure QoL and self-efficacy differences for the three groups before and after treatment, while linear- regression will be used to see the association between step count and QoL while adjusting for group differences.
Data analysis will be carried out using the Statistical Package for the Social Sciences (SPSS) software at a significant level (p <0.05).

Sample size: Assuming an effect size of d = 0.5 (medium effect size), an alpha of 0.05, a power of 80% and a standard deviation of 1498 step/day (Bai et al., 2022), a power analysis is done to determine a sample size. Considering 10% attrition rat a total of 209 participants required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
8/09/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 318621 0
Commercial sector/Industry
Name [1] 318621 0
HealthCare Software
Country [1] 318621 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 321170 0
None
Name [1] 321170 0
Address [1] 321170 0
Country [1] 321170 0
Other collaborator category [1] 283480 0
Commercial sector/Industry
Name [1] 283480 0
St. Lukes Health
Address [1] 283480 0
Country [1] 283480 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317224 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 317224 0
Ethics committee country [1] 317224 0
Australia
Date submitted for ethics approval [1] 317224 0
28/05/2025
Approval date [1] 317224 0
Ethics approval number [1] 317224 0

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

Contacts
Principal investigator
Name 140402 0
Dr Scott Pedersen
Address 140402 0
University of Tasmania - Newnham Campus, Newnham Dr., Launceston TAS 7248
Country 140402 0
Australia
Phone 140402 0
+61 03 6324 3554
Fax 140402 0
Email 140402 0
[email protected]
Contact person for public queries
Name 140403 0
Scott Pedersen
Address 140403 0
University of Tasmania - Newnham Campus, Newnham Dr., Launceston TAS 7248
Country 140403 0
Australia
Phone 140403 0
+61 03 6324 3554
Fax 140403 0
Email 140403 0
[email protected]
Contact person for scientific queries
Name 140404 0
Scott Pedersen
Address 140404 0
University of Tasmania - Newnham Campus, Newnham Dr., Launceston TAS 7248
Country 140404 0
Australia
Phone 140404 0
+61 03 6324 3554
Fax 140404 0
Email 140404 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    WATCH Study Protocol.docx


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.