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Trial registered on ANZCTR


Registration number
ACTRN12617000959370
Ethics application status
Approved
Date submitted
13/06/2017
Date registered
4/07/2017
Date last updated
4/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Active Minds, Happy Families: healthy lifestyles for preschoolers and their mums - a program targeting healthy levels of physical activity and sedentary behaviours in preschool children and their mums, and improvements in social skills and cognitive development in children
Scientific title
Active Minds, Happy Families: a family- and preschool-based intervention targeting physical activity and sedentary behaviours in preschool children and their mothers, children's social skills and cognitive functioning, and mothers' well-being
Secondary ID [1] 291381 0
Nil
Universal Trial Number (UTN)
Trial acronym
AMHF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 302394 0
Sedentary behaviour 302395 0
Screen time 302396 0
Emotional wellbeing 302397 0
Condition category
Condition code
Public Health 301971 301971 0 0
Health promotion/education
Mental Health 303223 303223 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active minds, happy families targets improvements in physical activity and sedentary behaviours in preschoolers' and their mothers. The program directly engages mothers, targets early childhood settings and utilises a stealth approach. The study is a pilot group randomised trial with a wait-list control group, involving a 10 week intervention and pre- and post-intervention assessments. Preschools and mothers with a child aged 3-5 years will be targeted. One hundred families across ten groups will be recruited and randomised to either a wait-list control or intervention group.

The intervention consists of face-to-face training for teachers, provision of equipment to preschools and online activities for mothers and preschool teachers. The program draws on constructs from the social cognitive and family systems theories and the ecological model. All strategies implemented are aimed at changing preschool social (e.g. practices, interactions with children) and physical (e.g. removal of chairs, provision of equipment) environments. Teachers will be provided with a 60 minute, in-house training session by experienced research staff (all teachers at each centre will be trained at the same time if available; training will be tailored to meet teacher and centre needs). Teachers will also receive access to a teacher-specific website which includes information addressing the individual (e.g. knowledge), social and physical environment levels of the ecological model through six modules.

These modules are: 1. outline of the program aims; 2. summary of program actions; 3. detailed information on each of the strategies of the program such as when it might be applicable to use each strategy and how they link with the Early Years Learning Framework; 4. an overview of the Early Years Learning Framework; 5. information on the background, need and rationale for the program; and 6. additional resources.

Teachers will be provided with on-going support by researchers throughout implementation, by request through phone call, email and/or speaking to teachers in person if required. Research staff will contact centre staff at least fortnightly throughout implementation of the program to provide an opportunity for questions and support. Centres will also be provided with equipment to support physical activity to the value of $200. The comprehensive website also targets mothers and consists of 5-10 minute modules which mothers will work through each week to develop skills and knowledge to support their behaviour change. Strategies will focus on activities aimed to support children's psychosocial wellbeing while encouraging behaviour change in both children and their mothers. Mothers will also receive targeted SMS messages to provide further information and support. Mothers will receive 2 SMS each week targeting awareness raising (e.g. impact of too much screen time) and strategies for behaviour change (e.g. activities to use to replace screen time).

Intervention code [1] 297441 0
Behaviour
Intervention code [2] 297442 0
Prevention
Comparator / control treatment
The study is a pilot group randomised trial with a wait-list control group, involving a ten week intervention and pre- and post-intervention assessments. Those in the control group will have the opportunity to participate in the intervention once follow-up data is collected.
Control group
Active

Outcomes
Primary outcome [1] 301502 0
Change in time spent in physical activity measured using ActiGraph accelerometer (internationally recognised and used activity monitors). Children will be wearing the monitor for a week at each timepoint to measure activity levels.
Timepoint [1] 301502 0
This outcome will be assessed immediately following the 10 week intervention.
Primary outcome [2] 301503 0
Change in time spent in sedentary behaviour measured using ActivPAL (internationally recognised and used activity monitors). Children will be wearing the monitor for a week at each timepoint to measure activity levels.
Timepoint [2] 301503 0
This outcome will be assessed immediately following the 10 week intervention.
Secondary outcome [1] 332874 0
Change in child screen time pre- to post-intervention. Outcome assessed by parent questionnaire. The questionnaire will capture the child's time in a number of types of screen time including TV viewing, computer use, smart phones and digital tablets. The questionnaire is based on the previously published HAPPY survey (Hinkley et al, 2012).
Timepoint [1] 332874 0
This outcome will be assessed immediately following the 10 week intervention.
Secondary outcome [2] 332876 0
Change in child's social skills pre- to post-intervention. Outcome assessed by parent report of child social skills using the "Social Skills Rating System".
Timepoint [2] 332876 0
This outcome will be assessed immediately following the 10 week intervention.
Secondary outcome [3] 332877 0
Changes in child cognitive functioning pre- to post-intervention. Children’s cognitive functioning, such as language skills and executive functioning, will be assessed using the NIH toolbox. The test is suitable for children aged 3-years and older.

Timepoint [3] 332877 0
This outcome will be assessed immediately following the 10 week intervention.
Secondary outcome [4] 332878 0
Centre environments: Trained research assistants will audit centre environment characteristics (e.g. availability and placement of equipment, use of chairs) and changes in preschool practices. This will be assessed using an observation instrument specifically designed for this study.
Timepoint [4] 332878 0
This outcome will be assessed immediately following the 10 week intervention.
Secondary outcome [5] 336478 0
Change in mother's screen time pre- to post-intervention. Outcome assessed by self-report. The questionnaire will capture the mother's time in a number of types of screen time including TV viewing, computer use, smart phones and digital tablets. Items are taken from the Active Australia Survey.
Timepoint [5] 336478 0
This outcome will be assessed immediately following the 10 week intervention.
Secondary outcome [6] 336479 0
Change in mother's physical activity pre- to post-intervention. Outcome assessed by self-report. The questionnaire will capture the mother's time in a number of types of physical activity, including leisure time PA and various intensities. Items are taken from the Active Australia Survey.
Timepoint [6] 336479 0
This outcome will be assessed immediately following the 10 week intervention.
Secondary outcome [7] 336480 0
Maternal mood will be assessed using the Center for Epidemiologic Studies Depression Scale.
Timepoint [7] 336480 0
This outcome will be assessed immediately following the 10 week intervention.

Eligibility
Key inclusion criteria
In 2017, eligible participating families will have one child aged between 3-5 years who attends preschool at one of the participating preschools. The only inclusion criteria for families is having a child aged between 3 to 5 years old enrolled at one of the participating centres. Key inclusion criteria for centres is participation of ten families and willingness to undertake intervention activities and implementation of strategies. This is our ONLY key inclusion criteria.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
We do not have any exclusion criteria

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
One hundred families across 10 groups will be recruited and randomised to either a wait-list control (n=50) or intervention (n=50) group. A random number generator will be used grouping participants into category 1 or category 2 which will correspond to the wait-list control or intervention groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
4/03/2017
Date of last participant enrolment
Anticipated
Actual
14/06/2017
Date of last data collection
Anticipated
28/07/2017
Actual
Sample size
Target
100
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295854 0
University
Name [1] 295854 0
Deakin University
Country [1] 295854 0
Australia
Primary sponsor type
Individual
Name
Trina Hinkley
Address
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country
Australia
Secondary sponsor category [1] 294716 0
None
Name [1] 294716 0
Address [1] 294716 0
Country [1] 294716 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297138 0
Deakin University Human Ethics Advisory Group - Health
Ethics committee address [1] 297138 0
Ethics committee country [1] 297138 0
Australia
Date submitted for ethics approval [1] 297138 0
19/12/2016
Approval date [1] 297138 0
31/01/2017
Ethics approval number [1] 297138 0
HEAG-H 207_2016

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

Contacts
Principal investigator
Name 73102 0
Dr Trina Hinkley
Address 73102 0
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country 73102 0
Australia
Phone 73102 0
+61392445480
Fax 73102 0
Email 73102 0
trina.hinkley@deakin.edu.au
Contact person for public queries
Name 73103 0
Trina Hinkley
Address 73103 0
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country 73103 0
Australia
Phone 73103 0
+61392445480
Fax 73103 0
Email 73103 0
trina.hinkley@deakin.edu.au
Contact person for scientific queries
Name 73104 0
Trina Hinkley
Address 73104 0
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country 73104 0
Australia
Phone 73104 0
+61392445480
Fax 73104 0
Email 73104 0
trina.hinkley@deakin.edu.au

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
No additional documents have been identified.