Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000999437
Ethics application status
Approved
Date submitted
22/07/2016
Date registered
28/07/2016
Date last updated
28/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Playing Actively Together (pit-a-PAT) Study: Pilot testing an innovative program for parents to increase young children’s active play and reduce screen time for a healthy start to life
Scientific title
Playing Actively Together (pit-a-PAT) Study: Pilot testing an innovative program for parents to increase young children’s active play and reduce screen time for a healthy start to life
Secondary ID [1] 289666 0
None
Universal Trial Number (UTN)
Trial acronym
pit-a-PAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 299466 0
Sedentary behaviour 299467 0
Condition category
Condition code
Public Health 299446 299446 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pit-a-PAT intervention is remotely-delivered to parents over six weeks via twice weekly mobile phone text messages and online content. The text messages provide short motivational or informational messages as well as links to content on the website. Website content includes downloadable videos, infographics, and written material proving information to assist parents with strategies to increase active play and reduce screentime in their young children (1-3 years of age). There is no requirement for parents to go to the website or spend a set amount of time on it, this is at their own discretion. Examples of modules covered: physical activity and sedentary behaviour guidelines for young children; ideas for active play; strategies for getting children off screens and engaging in active play.
Intervention code [1] 295291 0
Behaviour
Intervention code [2] 295407 0
Prevention
Intervention code [3] 295408 0
Lifestyle
Comparator / control treatment
The control group is a wait-list control; they received the full program after the follow up measures are taken (i.e., 6 weeks after their baseline assessments).
Control group
Active

Outcomes
Primary outcome [1] 298932 0
Time child spends in physical activity (total activity including light-, moderate-, and vigorous-intensity) assessed by accelerometers worn for one week.
Timepoint [1] 298932 0
Baseline (T1), post-intervention (6 weeks after baseline), and follow-up (12 weeks after baseline).
Primary outcome [2] 298933 0
Parent proxy-reported time child spends watching television and using other screens (screen-time).
Timepoint [2] 298933 0
Baseline (T1), post-intervention (6 weeks after baseline), and follow-up (12 weeks after baseline).
Secondary outcome [1] 325673 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] 325673 0
Post-intervention (6 weeks after baseline).
Secondary outcome [2] 325879 0
Physical activity parenting practices - assessed using a parent-report questionnaire developed by the research group.
Timepoint [2] 325879 0
Baseline (T1), post-intervention (6 weeks after baseline), and follow-up (12 weeks after baseline).
Secondary outcome [3] 326026 0
Parental efficacy for influencing their child's physical activity and sedentary behaviours - assessed using a parent-report questionnaire developed by the research group.
Timepoint [3] 326026 0
Baseline (T1), post-intervention (6 weeks after baseline), and follow-up (12 weeks after baseline).
Secondary outcome [4] 326027 0
Parental knowledge of recommended levels of physical activity and sedentary behaviour and benefits of these behaviours for young children - assessed using a parent-report questionnaire developed by the research group.
Timepoint [4] 326027 0
Baseline (T1), post-intervention (6 weeks after baseline), and follow-up (12 weeks after baseline).
Secondary outcome [5] 326028 0
Parental modelling: parents own physical activity and sedentary behaviour levels - assessed using the Active Australia Survey and previously validated questions on adult screen time (Salmon J, Owen N, Crawford D, Bauman A, Sallis JF. Physical activity and
sedentary behavior: a population-based study of barriers, enjoyment,
and preference. Health Psychol 2003;22:178-88).
Timepoint [5] 326028 0
Baseline (T1), post-intervention (6 weeks after baseline), and follow-up (12 weeks after baseline).
Secondary outcome [6] 326029 0
Program evaluation - assessed by the following: (1) open ended questions asking parents to report on what they liked and didn't like about the program overall and what (if anything) it made them do differently with their child; (2) 5-point likert scale responses on the usefulness and relevance of different aspects of the program; (3) number of text messages of different types (e.g. with links to videos, infographics, website) they read and number of each that gave them ideas that they used with their child.
Timepoint [6] 326029 0
Post-intervention (6 weeks after baseline)

Eligibility
Key inclusion criteria
Parents were eligible to participate if their child was aged between 1 and 3 years and had commenced walking. Parents were also required to be fluent in English.
Minimum age
1 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child not yet walking or outside the 1-3 year age range at commencement of the program. Parent not fluent in English

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)
A researcher not involved in recruitment or delivery of the intervention held the randomisation schedule and was contacted to provide the allocation once a participant consented and was deemed eligible.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using online computer software was used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear regression with bootstrapping for continuous outcomes and logistic regression for binary outcomes. Analyses on intention to treat basis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/10/2014
Date of last participant enrolment
Anticipated
Actual
8/05/2015
Date of last data collection
Anticipated
Actual
21/11/2015
Sample size
Target
100
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294057 0
University
Name [1] 294057 0
Institute for Physical Activity and Nutrition, Deakin University
Country [1] 294057 0
Australia
Primary sponsor type
University
Name
Institute for Physical Activity and Nutrition, Deakin University
Address
Deakin University
221 Burwood Highway,
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 292885 0
None
Name [1] 292885 0
Address [1] 292885 0
Country [1] 292885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295471 0
Deakin University
Ethics committee address [1] 295471 0
221 Burwood Highway,
Burwood VIC 3125
Ethics committee country [1] 295471 0
Australia
Date submitted for ethics approval [1] 295471 0
Approval date [1] 295471 0
08/09/2014
Ethics approval number [1] 295471 0
147_2014

Summary
Brief summary
This pilot intervention was tested in a randomised controlled trial involving approximately 100 families. It involves an innovative intervention remotely-delivered to parents (via mobile phone text messaging and online) which aims to increase physical activity (active play) and reduce screentime in their young children (1-3 years of age). A wait-list control design was implemented where control families received the intervention following a wait-list period. This design involved data collection at 3 time points, baseline (0 weeks), post intervention (6 weeks) and follow up/post wait list control receiving intervention (12 weeks). Children's physical activity and time spent in screen-based behaviors was measured via parent proxy reported surveys and also measured objectively using accelerometers at the 3 time points throughout the study. Measures of parental physical activity-related parenting practices, confidence, knowledge and modelling (parents' own physical activity and screen viewing) were also collected by self report. Being a pilot-trial, measures of feasibility and acceptability including retention and parent evaluation of the study components were also collected.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67394 0
A/Prof Kylie Hesketh
Address 67394 0
Deakin University
Institute for Physical Activity and Nutrition
221 Burwood Highway,
Burwood 3125
VIC
Country 67394 0
Australia
Phone 67394 0
+61 3 924 46812
Fax 67394 0
Email 67394 0
[email protected]
Contact person for public queries
Name 67395 0
A/Prof Kylie Hesketh
Address 67395 0
Deakin University
Institute for Physical Activity and Nutrition
221 Burwood Highway,
Burwood 3125
VIC
Country 67395 0
Australia
Phone 67395 0
+61 3 924 46812
Fax 67395 0
Email 67395 0
[email protected]
Contact person for scientific queries
Name 67396 0
A/Prof Kylie Hesketh
Address 67396 0
Deakin University
Institute for Physical Activity and Nutrition
221 Burwood Highway,
Burwood 3125
VIC
Country 67396 0
Australia
Phone 67396 0
+61 3 924 46812
Fax 67396 0
Email 67396 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

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