ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

AMHF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Physical activity

Sedentary behaviour

Screen time

Emotional wellbeing

Condition category

Condition code

Public Health

Health promotion/education

Mental Health

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]

Behaviour

Intervention code [2]

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]

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]