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Trial registered on ANZCTR


Registration number
ACTRN12614000597695
Ethics application status
Approved
Date submitted
30/05/2014
Date registered
5/06/2014
Date last updated
1/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity in disadvantaged pre-schools
Scientific title
Increasing physical activity among young children from disadvantaged communities via a multi-component, multi-setting intervention: a group randomised controlled effectiveness trial
Secondary ID [1] 284696 0
Nil
Universal Trial Number (UTN)
U1111-1157-5060
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 292050 0
sedentary behaviour 292051 0
Condition category
Condition code
Public Health 292389 292389 0 0
Health promotion/education
Diet and Nutrition 292421 292421 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We propose a group RCT using a nested-cohort design implemented over an 18-mo period. This design allows us to assess intervention effects at the 6- and 18-month follow-ups when the children assessed at baseline will still be attending the child care service (i.e., not transitioned to primary school).

Our intervention has one intervention arm that incorporates four main intervention components;
1. Motor development program to increase physical activity (Jump In and Jump Out).
2. Promoting physical activity through active ‘energy’ breaks (Jump Up).
3. Integrating physical activity with other learning areas (Jump Through).
4. Reinforcing child care programs with home-based interventions (Jump Home).


Intervention component 1: Gross motor development program (the Jump In and Jump Out program)

Educators will be trained to implement the Jump Start program in their service. (This program comprises of a 20 minute structured and 30 minute unstructured Physical Activity program that will be implemented in the centres.) Training will comprise a 1-day intensive workshops and five booster sessions for educators, delivered to all intervention services through the virtual connection (i.e. skype) provided through the Early Start Facility or face-to-face. The training will commence one month before the start of the intervention and booster sessions will occur every month following the 1-day intensive workshop for 5 months lasting for approximately 2 hours each. Thirteen motor skills will be covered to accommodate the longer intervention period in this study. In each 20-min structured session, children are encouraged to explore the different movement concepts and components of a motor skill and then to practise the skill through a series of fun and developmentally appropriate skill activities. Structured sessions will usually occur in the mornings and unstructured sessions in the afternoons following the structured lessons. In each 30-min unstructured session, children are encouraged to participate in free-play games and activities that align with the skill taught in the structured lessons. Based on our pilot studies, services will implement these sessions 5 days/wk as they find this easier to incorporate into their daily schedule.

Intervention component 2: Promoting physical activity through active ‘energy’ breaks (Jump Up)

Educators in each service will identify two periods in the day (excluding lunch and nap/quiet time) when children are indoors and can self-select sedentary activities of at least 20-min duration. During designated ‘target periods’, an automatic timer will be programmed to sound at a pre-selected time after 20 min has elapsed. Educators will instruct children to transition to a space where they can move freely and safely, and will lead children through a set activity using one of the cards from the Energise Me! Resource. The Energise Me! resource comprises a set of 27 cards, each describing a 3-min energy break, which educators used to facilitate the energy breaks 2 times/day. Training for this component of the intervention will be built into the professional development workshops for the Jump Start program, which will occur one month prior to the commencement of the intervention. Training will comprise a 1-day intensive workshops and five booster sessions for educators, delivered to all intervention services through the virtual connection (i.e. skype) provided through the Early Start Facility or face-to-face.

Intervention Component 3: Integrating physical activity with other learning areas (Jump Through)

Educators will be trained to integrate the Jump Through program into their service over the intervention period. The Jump Through program integrates gross motor movement into learning experiences, such as maths, language, social studies and science activities. For example, "Count your kicks" is a math activity which encourages children to count how many balloons they can kick in one minute. Training will comprise a 1-day intensive workshops and five booster sessions for educators, delivered to all intervention services through the virtual connection (i.e. skype) provided through the Early Start Facility or face-to-face. Educators within each service will work together as a team to plan for integrating at least two Jump Through activities each lasting at least 10 min each day.

Intervention Component 4. Reinforcing child care programs with home-based interventions (Jump Home)

Parents will be given opportunities to learn about Jump Start and participate in the same activities at home that the children have been participating in at the service. Parents/caregivers will be emailed and provided with hard copies of the home challenges each week. These challenges will focus on the same motor skill covered during the week in the Jump Start program and include the same activities the children participate in.

Process evaluation:

To determine the level of fidelity to the intervention for each childcare service, we will monitor the delivery of the intervention by asking educators to complete a brief online checklist for each Jump start component at the end of each week. In addition, we will observe one randomly-selected day using a purposively developed observation checklist in each service every 6 months and conduct an online survey to collect qualitative information on their experiences with Jump Start at the 6-month and 18-month time points. We will also collect data on days children attend each service. To determine the level of fidelity of the home-based component, parents will be asked to indicate the number of home challenges they completed with their child using a checklist provided online or hard copy.
Intervention code [1] 289488 0
Behaviour
Comparator / control treatment
We will compare our intervention with the current usual practice in this area. In most of the services this is the Munch and Move healthy eating and motor skills program. Munch and Move uses a 1-day (7hr) workshop to train educators (same length of training as our intervention) and provides resources and contact with health promotion officers from the local area health service. Although Munch and Move includes some physical activity education, it does not focus specifically on increasing physical activity and does not include components from our intervention model such as energy breaks, integration of physical activity with other learning areas, and home-based motor activities.
Control group
Active

Outcomes
Primary outcome [1] 292251 0
Time spent in total physical activity (minutes in light, moderate, vigorous physical activity [LMVPA]) over a usual day at preschool as measured by Actigraph GT3X+ accelerometers.
Timepoint [1] 292251 0
Accelerometers will be worn for 1 week at baseline, and at 6- and 18-months after intervention commencement.
Secondary outcome [1] 308539 0
Motor skill development as assessed by the second edition of the Test of Gross Motor Development (TGMD-2)
Timepoint [1] 308539 0
Baseline, and at 6- and 18-months after intervention commencement.
Secondary outcome [2] 308540 0
Time spent in moderate-to-vigorous physical activity (MVPA) and sedentary behaviour as assessed by Actigraph GT3X+ accelerometers.
Timepoint [2] 308540 0
Accelerometers will be worn for 1 week at baseline, and at 6- and 18-months after intervention commencement.
Secondary outcome [3] 308541 0
Adiposity as assessed by measuring height and weight and calculating BMI.
Timepoint [3] 308541 0
Baseline, and at 6- and 18-months after intervention commencement.
Secondary outcome [4] 308542 0
Bone density using the quantitative transaxial ultrasound method.
Timepoint [4] 308542 0
Baseline, and at 6- and 18-months after intervention commencement.
Secondary outcome [5] 308543 0
Behavioural self-regulation (inhibitory control, working memory, attention focusing) as assessed using a battery of assessment tasks, including the Head-Toes-Knees-Shoulder task, Card sort, Fish and shark task, Mr Ant task, Not This task, Temperament scale, Approaches to Learning scale.
Timepoint [5] 308543 0
Baseline, and at 6- and 18-months after intervention commencement.
Secondary outcome [6] 308544 0
Parent and educator self-efficacy as assessed using the Parent Self-efficacy Instrument and the Educator Self-efficacy Instrument.
Timepoint [6] 308544 0
Baseline, and at 6- and 18-months after intervention commencement.
Secondary outcome [7] 308545 0
Demographic measures (child age, sex, Aboriginal or Torres Strait Islander (ATSI), cultural and Linguistic Diversity (CALD); family education, income, ATSI, CALD and family structure; educators’ age, sex, qualifications, years of experience (in child care and in this service), level of training and experience in physical activity and motor skill development) as assessed by a questionnaire.
Timepoint [7] 308545 0
Baseline
Secondary outcome [8] 308546 0
Economic measures will be assessed including intervention and control costs associated with researchers' and educator' training and educator time to implement programs across the intervention period.
Timepoint [8] 308546 0
At the conclusion of the intervention.
Secondary outcome [9] 308571 0
Project fidelity (process evaluation) using online checklists and observation checklists documenting implementation, attendance records, and face-to-face interviews.
Timepoint [9] 308571 0
Online checklists and attendance records: weekly after intervention commencement. Observation checklist: every month after intervention commencement. Interviews: at 6- and 18-months after intervention commencement.

Eligibility
Key inclusion criteria
All children aged 3 at baseline who attend their childcare service for at least 2 days/week will be invited to participate.

Childcare services need to have at least 5 consenting participants to be eligible for the study.
Minimum age
3 Years
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not applicable

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)
The participants will be contacted through all 38 Early Start Engagement Centres, who have already signed a letter of collaboration as part of being an Engagement Centre, and 10 non-Early Start Engagement Centres.

Parents of children who are currently enrolled in each early childhood service will be approached and asked to participate.

Parents/Guardians will receive a Participant Information Sheet and consent form. This information sheet will inform the parent/guardian of the project description and the child’s involvement in the project. It will describe what data will be collected from the child and what activities they will be involved in. A recruitment video will also be shown to the parents and caregivers explaining the study.

Centres will be paired according to the number of educators and children in attendance. Following recruitment and baseline testing, each pair will be randomised to the intervention or control group by the statistician using a concealed computerised random number generator. The statistician will communicate the allocation to the Project Manager, who will inform each child care service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All preschool centres will be paired according to the number of educators and children in attendance. Each pair will be randomised to the intervention or control group by the statistician using simple randomisation using a randomisation table created by a computerised random number generator.
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
Sample size and power estimates are based on the formula to adjust for a clustered (nested) cohort design. We anticipate a between- group difference of 45 min/day of physical activity with an effect size of 0.4 and an intraclass correlation (ICC) of 0.01–0.05. The proposed design has 38 services (19 per group) and 16 children completing per service. Allowing for participation of 20 eligible with four dropouts per service [20%] gives a total sample size of 608. The degrees of freedom for the adjusted t test calculation are 36. Given this design, the power estimates at alpha = 0.05 are greater than 86% for the ICC range proposed.

Primary analysis. Analysis of the primary outcome will be conducted using a linear or generalized mixed model in SAS V9.2 (or higher). The mixed model will contain a random effect for time and child care service nested within group. Degrees of freedom will be altered manually in the code to adjust for the effect of clustering. These established procedures are well documented and have been used previously by the authors to analyse a similar study in primary schools. No interim analyses are planned.

Secondary analyses. Mixed models will also be used to analyse the differences between treatment and control groups for all continuous secondary outcome variables.

Mediation and moderation analyses. Two types of analyses will be conducted to explore the theoretical assumptions of the intervention. First, hypothesised mediators of change in physical activity (e.g., staff self-efficacy and child motor skills) will be examined using multilevel linear analysis and a product-of-coefficients test appropriate for cluster RCTs. Potential moderators of the intervention effects (e.g., child age and sex) will also be explored using multi-level modelling.

Per-protocol analyses. A per-protocol or dose-response analysis will also be performed at the service and child levels. Child-level compliance will be defined completing greater than or equal to 50% of home-based activities, and having worn the accelerometers for the entire week. Service-level compliance will be defined as: implementing greater than or equal to 90% of planned structured and unstructured activity sessions; greater than or equal to 80% of scheduled energy breaks implemented; and greater than or equal to 80% of Move and Learn activities implemented. Although all children and services will be included in the intention-to-treat analyses, only children and services that comply with all of the above requirements will be included in the per-protocol analysis. These compliance measures will also allow us to determine the relative effectiveness of each component which will be important to guide further translational work.

Economic analyses
Over the intervention period, incremental effects on the primary outcome will be compared with incremental costs to inform within-trial cost-effectiveness. This will provide the basis for modelling cost-effectiveness beyond the study. Within the trial, incremental costs and effects under uncertainty and their bivariate distribution will be estimated with bootstrapping (re-sampling with replacement) on paired service level costs and effects (with service level effects in turn bootstrapping on individual student effects). This approach allows robust estimation of the joint distribution under uncertainty and for the relationship (covariance) between costs and effects observed within the study and the uncertainty of effects across children within services. Standard summary measures for cost-effectiveness analysis, including net benefit curves, cost-effectiveness acceptability curves, and expected net loss curves and frontiers will be presented to best inform societal decision makers of the net benefit of the intervention and value of future research.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
19/01/2015
Actual
19/01/2015
Date of last participant enrolment
Anticipated
13/04/2015
Actual
1/06/2015
Date of last data collection
Anticipated
24/02/2017
Actual
Sample size
Target
608
Accrual to date
Final
658
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289322 0
Government body
Name [1] 289322 0
National Health and Medical Research Council
Country [1] 289322 0
Australia
Primary sponsor type
Individual
Name
Professor Tony Okely
Address
University of Wollongong
Wollongong NSW Australia 2522
Country
Australia
Secondary sponsor category [1] 287993 0
Individual
Name [1] 287993 0
Professor Stewart Trost
Address [1] 287993 0
Queensland University of Technology
GPO Box 2434
Brisbane, QLD 4001
Country [1] 287993 0
Australia
Secondary sponsor category [2] 287994 0
Individual
Name [2] 287994 0
Professor Donna Bethelsen
Address [2] 287994 0
Queensland University of Technology
GPO Box 2434
Brisbane, QLD 4001
Country [2] 287994 0
Australia
Secondary sponsor category [3] 287995 0
Individual
Name [3] 287995 0
Professor Jo Salmon
Address [3] 287995 0
Deakin University
221 Burwood Highway
Burwood Victoria 3125 Australia
Country [3] 287995 0
Australia
Secondary sponsor category [4] 287996 0
Individual
Name [4] 287996 0
Professor John Reilly
Address [4] 287996 0
University of Strathclyde
16 Richmond Street, Glasgow G1 1XQ
Scotland, United Kingdom
Country [4] 287996 0
United Kingdom
Secondary sponsor category [5] 287997 0
Individual
Name [5] 287997 0
Dr Dylan Cliff
Address [5] 287997 0
University of Wollongong
Wollongong NSW Australia 2522
Country [5] 287997 0
Australia
Secondary sponsor category [6] 287998 0
Individual
Name [6] 287998 0
Dr Rachel Jones
Address [6] 287998 0
University of Wollongong
Wollongong NSW Australia 2522
Country [6] 287998 0
Australia
Secondary sponsor category [7] 287999 0
Individual
Name [7] 287999 0
Dr Marika Batterham
Address [7] 287999 0
University of Wollongong
Wollongong NSW Australia 2522
Country [7] 287999 0
Australia
Secondary sponsor category [8] 288000 0
Individual
Name [8] 288000 0
Professor Ngiare Brown
Address [8] 288000 0
University of Wollongong
Wollongong NSW Australia 2522
Country [8] 288000 0
Australia
Secondary sponsor category [9] 288001 0
Individual
Name [9] 288001 0
Professor Simon Eckermann
Address [9] 288001 0
University of Wollongong
Wollongong NSW Australia 2522
Country [9] 288001 0
Australia
Secondary sponsor category [10] 288002 0
Individual
Name [10] 288002 0
Dr Karen Mickle
Address [10] 288002 0
Victoria University Melbourne VIC Australia 3011
Country [10] 288002 0
Australia
Secondary sponsor category [11] 288003 0
Individual
Name [11] 288003 0
Professor Paul Chandler
Address [11] 288003 0
University of Wollongong
Wollongong NSW Australia 2522
Country [11] 288003 0
Australia
Secondary sponsor category [12] 288004 0
Individual
Name [12] 288004 0
Dr Steven Howard
Address [12] 288004 0
University of Wollongong
Wollongong NSW Australia 2522
Country [12] 288004 0
Australia
Secondary sponsor category [13] 288005 0
Individual
Name [13] 288005 0
Dr Trina Hinkley
Address [13] 288005 0
Deakin University
221 Burwood Highway
Burwood Victoria 3125 Australia
Country [13] 288005 0
Australia
Secondary sponsor category [14] 288006 0
Individual
Name [14] 288006 0
Dr Xanne Janssen
Address [14] 288006 0
University of Strathclyde
16 Richmond Street, Glasgow G1 1XQ
Scotland, United Kingdom
Country [14] 288006 0
United Kingdom
Secondary sponsor category [15] 288007 0
Individual
Name [15] 288007 0
Dr Bianca Suesse
Address [15] 288007 0
University of Wollongong
Wollongong NSW Australia 2522
Country [15] 288007 0
Australia
Secondary sponsor category [16] 288008 0
Individual
Name [16] 288008 0
Dr Rebecca Stanley
Address [16] 288008 0
University of Wollongong
Wollongong Australia NSW 2522
Country [16] 288008 0
Australia
Secondary sponsor category [17] 288009 0
Individual
Name [17] 288009 0
Mrs Penny Cross
Address [17] 288009 0
University of Wollongong
Wollongong NSW Australia 2522
Country [17] 288009 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291089 0
University of Wollongong, Illawarra, Shoalhaven Local Health District Human Research Ethics Committee
Ethics committee address [1] 291089 0
Ethics committee country [1] 291089 0
Australia
Date submitted for ethics approval [1] 291089 0
02/04/2014
Approval date [1] 291089 0
27/05/2014
Ethics approval number [1] 291089 0
HE14/137

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1409 1409 0 0
/AnzctrAttachments/366440-art%3A10.1186%2Fs12889-016-3743-0.pdf (Protocol)

Contacts
Principal investigator
Name 48818 0
Prof Tony Okely
Address 48818 0
University of Wollongong
Wollongong NSW 2522
Country 48818 0
Australia
Phone 48818 0
+61 2 4221 4641
Fax 48818 0
Email 48818 0
[email protected]
Contact person for public queries
Name 48819 0
Tony Okely
Address 48819 0
University of Wollongong
Wollongong NSW 2522
Country 48819 0
Australia
Phone 48819 0
+61 2 4221 4641
Fax 48819 0
Email 48819 0
[email protected]
Contact person for scientific queries
Name 48820 0
Tony Okely
Address 48820 0
University of Wollongong
Wollongong NSW 2522
Country 48820 0
Australia
Phone 48820 0
+61 2 4221 4641
Fax 48820 0
Email 48820 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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