Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000628448
Ethics application status
Approved
Date submitted
12/05/2016
Date registered
16/05/2016
Date last updated
22/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mini Movers: A study evaluating the efficacy of a program to reduce sedentary behaviour in 2- to 4-year-old children.
Scientific title
A pilot randomised controlled trial (RCT) examining the efficacy of a parent-focused information program to reduce sedentary behaviour in 2- to 4-year-old children.
Secondary ID [1] 289119 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour 298589 0
Condition category
Condition code
Public Health 298664 298664 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will participate in one group session (approximately 30 minutes), where they will be provided with information about sedentary behaviour, screen time and active play for their child. The session will be delivered by the PhD Candidate/Project Manager during the participants' playgroup time (at the usual playgroup setting). At this session they will receive, and be talked through, a booklet with information about the behaviours, guidelines for sedentary behaviour and physical activity in early childhood, ideas for active play and limiting screen time, and information about goal setting. They will then be asked to set two SMART (Specific, Measurable, Attainable, Relevant, Time-bound) goals relating to the outcomes of the study: one for increasing active play and one for limiting screen time. Parents will also receive 2-3 tailored text messages per week (for 6 weeks), which will include tips for limiting sedentary behaviour, ideas for active play, and prompts to check their progress with their goals.
Intervention code [1] 294708 0
Behaviour
Comparator / control treatment
The control group will be a wait-list control; they receive the full program after the follow up measurements are taken (i.e., 7 weeks after the intervention group starts the program).
Control group
Active

Outcomes
Primary outcome [1] 298243 0
Change in screen time (minutes per day) measured by parent-report (reliability previously established)
Timepoint [1] 298243 0
Pre-intervention (baseline) and post-intervention (6 weeks post intervention commencement)
Primary outcome [2] 298244 0
Change in sedentary time (minutes per day) measured objectively with activPAL accelerometers (valid and reliable in this population). activPALs will be worn for 7 consecutive days at both timepoints.
Timepoint [2] 298244 0
Pre-intervention (baseline) and post-intervention (6 weeks post intervention commencement)
Secondary outcome [1] 323697 0
Feasibility: recruitment and retention - recruitment numbers will be recorded and retention calculated by the number of participants still enrolled in the program post-intervention
Timepoint [1] 323697 0
Post-intervention (i.e. 6 weeks post intervention commencement)
Secondary outcome [2] 323812 0
Feasibility: dose delivered - measured by attendance at the group session and with purposed-designed parent survey questions (e.g., "How many of the text messages did you read/click through to the links?")
Timepoint [2] 323812 0
Post-intervention (i.e. 6 weeks post intervention commencement)
Secondary outcome [3] 323813 0
Feasibility: engagement in the intervention - measured by parent responses to goal-checking text messages and qualitative telephone interviews (asking questions usefulness/relevance of the session and text messages)
Timepoint [3] 323813 0
Post-intervention (i.e. 6 weeks post intervention commencement)

Eligibility
Key inclusion criteria
Parents will be eligible to be included in the study if their child is between 2 to 4 years and they can speak, read and write fluent English.
Minimum age
2 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Allocation concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using online computer software will be used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2016
Actual
14/07/2016
Date of last participant enrolment
Anticipated
1/11/2016
Actual
27/10/2016
Date of last data collection
Anticipated
31/03/2017
Actual
23/03/2017
Sample size
Target
100
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293567 0
Government body
Name [1] 293567 0
NHMRC Postgraduate Scholarship
Country [1] 293567 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 292387 0
None
Name [1] 292387 0
Address [1] 292387 0
Country [1] 292387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295010 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 295010 0
Ethics committee country [1] 295010 0
Australia
Date submitted for ethics approval [1] 295010 0
04/04/2016
Approval date [1] 295010 0
02/06/2016
Ethics approval number [1] 295010 0
2016-103

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

Contacts
Principal investigator
Name 65458 0
A/Prof Kylie Hesketh
Address 65458 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Country 65458 0
Australia
Phone 65458 0
+61392446812
Fax 65458 0
Email 65458 0
[email protected]
Contact person for public queries
Name 65459 0
Katherine Downing
Address 65459 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Country 65459 0
Australia
Phone 65459 0
+61392446088
Fax 65459 0
Email 65459 0
[email protected]
Contact person for scientific queries
Name 65460 0
Katherine Downing
Address 65460 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Country 65460 0
Australia
Phone 65460 0
+61392446088
Fax 65460 0
Email 65460 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseA mobile technology intervention to reduce sedentary behaviour in 2- to 4-year-old children (Mini Movers): Study protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s13063-017-1841-7
N.B. These documents automatically identified may not have been verified by the study sponsor.