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Trial registered on ANZCTR


Registration number
ACTRN12620001280998
Ethics application status
Approved
Date submitted
3/09/2020
Date registered
26/11/2020
Date last updated
28/10/2024
Date data sharing statement initially provided
26/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Let's Grow: Evaluating the efficacy of a mobile-web app on sedentary behaviour, physical activity and sleep in 2-year-old children.
Scientific title
A randomised controlled trial (RCT) examining the efficacy of a parent-focused, mobile-web app delivered intervention on sedentary behaviour, physical activity and sleep in 2-year-old children.
Secondary ID [1] 301218 0
NHMRC Project Grant GNT1162980
Universal Trial Number (UTN)
U1111-1252-0599
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour 317385 0
Physical inactivity 317386 0
Sleep 317387 0
Condition category
Condition code
Public Health 315492 315492 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention content will be delivered via a mobile web app (named “Let’s Grow”) and SMS notifications. Participants in the intervention group will work through eight modules within the app in their own time over 12 months. There will be 'refresher' notifications pushing participants back to the app for those who complete the modules in less than 12 months.

Each module contains content on parenting and a combination of behaviours (physical activity, sedentary behaviour and sleep), highlighting the interplay between the behaviours in line with the 24-hour movement paradigm (e.g. replacing screen time with active play). In addition, core content is contained within a ‘toolkit’ e.g. parenting strategies, active play ideas, screen free ideas, common sleep issues. Intervention content has been developed by a team of experts and incorporates practical advice, established behaviour change techniques (e.g., goal setting, self-monitoring), and tips and tools to assist parents/caregivers to improve their child’s physical activity, sleep and sedentary behaviour. This includes information about the behaviours, guidelines in early childhood, ideas for promoting each of the behaviours, parenting strategies, and tasks to put participant learning into action, e.g., quizzes, goal setting, self monitoring, creation of routines. Information will be presented using text, infographics, animations and live action videos. The app will also contain a social forum that parents will have the option to participate in should they wish to. Module content takes approximately 10min to read/view; the interactive tasks conducted offline with assistance from notifications are undertaken over a period of 2-5 weeks (e.g. goal setting) per module.

Parents will also receive SMS notifications over the course of the intervention to assist with monitoring progress of ongoing activities (e.g. goal setting and self monitoring), to remind them of key messages, and to push them back to app content. Notifications will be personalised to include the parent and child names and their chosen goal/s (where appropriate).

Intervention adherence will be monitored by app usage data. Automated notifications will be sent after predetermined periods of app inactivity to encourage participants to re-engage and complete the program. If there is continued inactivity after two automated notifications, research staff will contact participants to encourage continuation of the program.
Intervention code [1] 317528 0
Behaviour
Intervention code [2] 317529 0
Lifestyle
Comparator / control treatment
The control group will not have access to the app. They will receive eight electronic newsletters on unrelated topics (e.g., common childhood illnesses, basic child first aid, common parent concerns such as hearing or speech development) across the course of the 12-month intervention period for cohort retention and will continue with any usual care.
Control group
Active

Outcomes
Primary outcome [1] 323732 0
Average daily proportion of time spent in physical activity, sedentary behaviour and sleep (composite outcome).
Assessed concurrently using ActiGraph GT3X+ accelerometers, worn continuously for 24-h across eight consecutive days.
Timepoint [1] 323732 0
Pre-intervention (baseline/T0); following completion of 12 month intervention phase (T2 – primary outcome); 1 year post intervention follow-up (T3); 3 years post intervention follow-up (T4)
Secondary outcome [1] 384485 0
Parent-report of child physical activity. Parents will report the amount of time their child spends in a range of physical activities (e.g. organised activities, unstructured active play). This outcome will be assessed via a study-specific questionnaire using a mix of established and purpose-designed items.
Timepoint [1] 384485 0
Pre-intervention (baseline/T0); following completion of 12 month intervention phase (T2 – primary outcome); 1 year post intervention follow-up (T3); 3 years post intervention follow-up (T4)
Secondary outcome [2] 388225 0
Parent-report of child sedentary behaviour. Parents will report the amount of time their child spends in a range of screen and non-screen based sedentary behaviours (e.g. TV, computer, tablet, smart phone; seated play, situations that restrict movement such as strollers). This outcome will be assessed via a study-specific questionnaire using a mix of established and purpose-designed items.
Timepoint [2] 388225 0
Pre-intervention (baseline/T0); following completion of 12 month intervention phase (T2 – primary outcome); 1 year post intervention follow-up (T3); 3 years post intervention follow-up (T4)
Secondary outcome [3] 388226 0
Parent-report of child sleep. Parents will report the amount of time their child spends sleeping (e.g. usual bedtime and wake time, night waking, sleep routines). This outcome will be assessed via relevant subscales from the Child Sleep Habits Questionnaire (CSHQ) and the Brief Infant Sleep Questionnaire-Revised (BISQ-R).
Timepoint [3] 388226 0
Pre-intervention (baseline/T0); following completion of 12 month intervention phase (T2 – primary outcome); 1 year post intervention follow-up (T3); 3 years post intervention follow-up (T4)

Eligibility
Key inclusion criteria
Parent or primary caregiver of an 18-month-old child, resides in Australia, has a web-enabled mobile phone, can complete assessments in English, and child is walking.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child has a condition that impacts movement (e.g. requires a walking frame or wheelchair) or sleep (clinical sleep disorder, screened by relevant item in the Brief Infant Sleep Questionnaire).

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)
Automated concealed allocation by software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised generation of 14 sequences to allow stratified allocation based on geographical location (state and city/regional city vs rural/remote)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit 1100 families to ensure complete accelerometry data on approximately 700 children at intervention conclusion (T2) and 620 at 12 month and 3-year follow-up (T3 and T4). Retention figures use conservative estimates and are based on the extensive experience of the investigator team, published papers in the field and on established statistical methods. This will provide us with >85% power to detect meaningful changes in our primary outcome (average daily proportion of time spent in physical activity, sedentary behaviour and sleep) at these time points.

All analyses will be conducted on an intention-to-treat basis. Compositional analysis will be undertaken. Proportion of time-use data will be transformed into log-ratios; the fraction of daily time spent in physical activity (x1), sedentary behaviour (x2) and sleep (x3) will be transformed to new variables y1=log(x1/x3) and y2=log(x1/x3) using the proportion of time spent sleeping as a reference. This transformation converts the vector of proportions (x1, x2, x3), which sum to 1, into a bi-dimensional vector (y1, y2) whose components are no longer constrained and can be analysed using standard multivariate data analysis. The intervention effect on the log-ratio transformed time-use data will be estimated using a multivariate linear mixed-effect model with trial arm as fixed effect and a 2×2 unstructured variance-covariance matrix to account for the correlation between components’ proportions. To facilitate interpretation, estimated mean log-ratios will be back transformed into proportion of time (minutes/day) in each behaviour. We will further estimate the longitudinal effect of the intervention on the log-ratio transformed proportions using a multivariate linear mixed-effect model with trial arm, time (T0, T1, T2, T3, T4) and interaction arm × time as fixed effects, child as a random effect to account for the repeated measures, and a 2×2 unstructured variance-covariance matrix.

Intervention effects on parent reported time in various movement behaviours will be estimated using generalized estimating equation models with link and distribution selected according to the outcome. All models will include trial arm, time and arm × time effects. Mediation effects will be explored using the counterfactual framework. The mediated (indirect) effect will be computed through G-estimation incorporating confounders of the mediator-outcome association.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/01/2021
Actual
2/03/2021
Date of last participant enrolment
Anticipated
2/08/2021
Actual
16/06/2022
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
1100
Accrual to date
Final
1367
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305665 0
Government body
Name [1] 305665 0
NHMRC Project Grant
Country [1] 305665 0
Australia
Funding source category [2] 317713 0
Charities/Societies/Foundations
Name [2] 317713 0
National Heart Foundation
Country [2] 317713 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 306076 0
None
Name [1] 306076 0
Address [1] 306076 0
Country [1] 306076 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305949 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 305949 0
Ethics committee country [1] 305949 0
Australia
Date submitted for ethics approval [1] 305949 0
13/03/2020
Approval date [1] 305949 0
10/09/2020
Ethics approval number [1] 305949 0
2020-077

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

Contacts
Principal investigator
Name 102174 0
Prof Kylie Hesketh
Address 102174 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Country 102174 0
Australia
Phone 102174 0
+61392446812
Fax 102174 0
Email 102174 0
kylie.hesketh@deakin.edu.au
Contact person for public queries
Name 102175 0
Savannah Simmons
Address 102175 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Country 102175 0
Australia
Phone 102175 0
+61392445629
Fax 102175 0
Email 102175 0
savannah.simmons@deakin.edu.au
Contact person for scientific queries
Name 102176 0
Kylie Hesketh
Address 102176 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Country 102176 0
Australia
Phone 102176 0
+61392446812
Fax 102176 0
Email 102176 0
kylie.hesketh@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified individual participant outcome data.
When will data be available (start and end dates)?
Following publication, with no end date.
Available to whom?
Researchers who provide a methodologically sound proposal, and on a case-by-case basis at the discretion of lead investigator.
Available for what types of analyses?
For analysis related to the aims of this study, in line with ethics requirements.
How or where can data be obtained?
From lead study investigator: Professor Kylie Hesketh at kylie.hesketh@deakin.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8908Study protocolHesketh KD, Downing KL, Galland BC, et al. Protocol for the Let's Grow randomised controlled trial: examining efficacy, cost-effectiveness and scalability of a m-Health intervention for movement behaviours in toddlers. BMJ Open 2022;12:e057521. doi: 10.1136/bmjopen-2021-057521https://doi.org/10.1136/bmjopen-2021-057521 



Results publications and other study-related documents

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