Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000715279
Ethics application status
Approved
Date submitted
19/08/2009
Date registered
19/08/2009
Date last updated
29/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Transform-Us!: an intervention promoting children's health.
Scientific title
A multi-setting intervention to reduce sedentary behaviour, promote physical activity and improve children's health.
Secondary ID [1] 295363 0
ISRCTN83725066
Universal Trial Number (UTN)
Trial acronym
Transform-Us!
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour in children 243537 0
Physical activity in children 243538 0
Cardiovascular disease risk in children 243539 0
Diabetes risk in children 243540 0
Condition category
Condition code
Public Health 239837 239837 0 0
Epidemiology
Public Health 239838 239838 0 0
Health promotion/education
Cardiovascular 239839 239839 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 2-year behavioural intervention targeted at reducing sedentary behaviour (SB-I) and increasing physical activity (PA-I) alone or in combination (SB+PA-I) among 8-9 year old children will be delivered through primary schools, with home-based components. A current practice, control arm (C) will serve as a comparison. The materials are based on Social Cognitive Theory, Behavioural Choice Theory and Ecological Systems Theory.

School based component:
- Teachers in the SB-I program will increase the proportion of class time that children spend continuously active by delivering one lesson (30-minutes per day) of their standard curriculum via an alternative method which requires the children to be standing (eg 30-minute standing lessons) and reducing periods of continuous sitting by including short (2-minunte) ‘standing breaks’ every 30 minutes during teaching blocks (eg. children stand and discuss the current activity);
- Teachers in the PA -I program will increase children’s physical activity during recess and lunch times through increased teacher supervision and encouragement (ie teachers actively encourage children to be active during school breaks); our provision of additional signage in the school grounds (eg ground court markings); and our provision of additional equipment (eg bats and balls).
- Teachers in the SB +PA-I program will combine the above strategies to both interrupt extended periods of sitting and increase time spent in physical activity during breaks.
- Teachers in the C schools are will continue their current procedures, policy and practice.

Over the two years, class teachers in the SB-I, PA-I and SB+PA-I groups will also deliver to their students a series of 18 ‘key messages’ developed by the research team, targeted at their intervention arms’ relevant behaviours (eg selective viewing, behavioural contracts). The messages are designed to be easily incorporated into the current learning theme. The researchers will provide resources for this component and teachers are encouraged to incorporate them into their current curriculum.

Home-based component
Teachers will give children regular homework activities which will focus on reducing time spent in sedentary leisure activities at home (SB-I), increasing physical activity at home (PA-I) or a combination of these (SB+PA-I). Ideas and resources will be provided by the researchers and the teachers will be encouraged to adapt their current homework tasks to match the aim of their intervention arm. Examples of such homework include
SB-I: “Switch off the TV ...” contracts, or
PA-I: ‘walking around the neighbourhood’ tasks that incorporate current learning (eg. counting letterboxes), and
SB+PA-I: “Switch off the computer and go for a family walk” tasks.

In addition, parents will receive eight newsletters and will be invited to attend and two parent information nights to provide families with information about the program aims and progress and to reinforce the behavioural changes.
Intervention code [1] 241146 0
Prevention
Intervention code [2] 241147 0
Behaviour
Intervention code [3] 241148 0
Lifestyle
Comparator / control treatment
No treatment. Schools will continue with current practices. Eight generic newsletters of equivalent size to those used in the intervention groups will be sent to parents during the 2 years which will contain educational material unrelated to physical activity or sedentary behaviour.
Control group
Active

Outcomes
Primary outcome [1] 240602 0
Sedentary time and physical activity, objectively assessed using Manufacturing Technology Inc. (MTI) Actigraph Model, AM7164-2.2C accelerometers and activPALs. Children wear the accelerometers and activPALs during waking hours for eight days at each measurement point. Movement count thresholds (based on age-specific energy expenditure prediction equations) will be used to calculate the average time spent being sedentary, number of breaks to sedentary time, and time spent in moderate- and vigorous- intensity activity. Accelerometry data from specific times of the day (eg, after-school hours, during class time) will be extracted to identify when changes in physical activity or sedentary behaviour occurred. A random sample of children will wear an activPAL. Data obtained will be used to identify periods of sitting, standing and walking.
Timepoint [1] 240602 0
Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).
Primary outcome [2] 240606 0
Behavioural information on the types of activities in which children participate, collected by a parental proxy-report version of the validated Children's Leisure Activities Study (CLASS) questionnaire which assesses children's participation (frequency and duration) in 30 physical activities (eg, walking to school, playing various sports), and 9 sedentary behaviours (eg, homework, watching TV, reading) during a typical week and weekend. Time spent outdoors will be assessed using a previously validated proxy-report measure.
Timepoint [2] 240606 0
Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).
Secondary outcome [1] 257235 0
Body Mass Index (BMI) (kg/m2), obtained via height and weight assessments without shoes, using a portable stadiometer and digital scales, performed by trained research staff privately at school. BMI will be calculated and converted as recommended for analysis of longitudinal adiposity data. Children will also be categorised as healthy weight or overweight/obese based on International Obesity Task Force definitions.
Timepoint [1] 257235 0
Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).
Secondary outcome [2] 257236 0
Waist circumference, assessed using a flexible tape measure at the level of the narrowest point between the lower costal border and the iliac crest (or the midpoint if not obvious) by trained research staff privately at school. Sex and age-specific waist circumference thresholds for children that correspond to clustering of cardiovascular disease risk factors will be applied.
Timepoint [2] 257236 0
Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).
Secondary outcome [3] 257237 0
Biomarkers in a fasting blood sample, collected at school at the beginning of the school day by a paediatric phlebotomist. Levels of insulin, glucose, total cholesterol, high-density lipoprotein (HDL) cholesterol, calculated low-density lipoprotein (LDL) cholesterol, triglycerides, C -Reactive Protein, Vitamin D and insulin resistance (homeostasis model assessment (HOMA)) will be assessed by a commercial pathology laboratory.
Timepoint [3] 257237 0
Baseline, 24 months (post-intervention), 36 months (12-months follow-up).
Secondary outcome [4] 257240 0
Blood pressure, assessed using an A&D Mercury (Model US-767 PC) home blood pressure digital monitor with a paediatric cuff by trained research staff.
Timepoint [4] 257240 0
Baseline, 24 months (post-intervention), 36 months (12-months follow-up).
Secondary outcome [5] 257244 0
The mediators (how did the intervention work) and moderators (who did the intervention work for) of the intervention, will be determined through parent proxy-report and children's self-report questionnaires.
Timepoint [5] 257244 0
Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).
Secondary outcome [6] 257245 0
Cost-effectiveness of each intervention arm, determined through cost-utility analysis (CUA), whereby outcomes are expressed in terms of '$ cost per Disability-Adjusted Life Year saved'. Cost-effectiveness analysis (CEA) will also be undertaken, where the intermediate results will be expressed as '$ cost per Unit of Body Mass Index (BMI) saved'.
Timepoint [6] 257245 0
Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).

Eligibility
Key inclusion criteria
Participants will be children entering Grade 3 in 2010 at one of the 22 randomly selected Primary Schools in Metropolitan Melbourne where the study will be conducted.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
On ethical grounds, there will be no exclusion criteria for participants; however, potential confounders will be assessed using parent report of their child’s health.

Potential participant Primary Schools will undergo an audit of current policies and strategies targeted at physical activity and sedentary behaviour and those that already have relevant action plans or programs in place will be excluded.

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)
Randomisation will occur at the school level in a cluster design. All children in the target year levels (Grades 3 in 2010 and 4 in 2011) at participating schools will receive the intervention arm that the school has been allocated, as the intervention will be embedded in the school curriculum (with previous consent given by the school council).
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be randomised to one of the four groups (three intervention or one control) using computer-generated blocks of 4.
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
1/09/2009
Actual
19/11/2009
Date of last participant enrolment
Anticipated
Actual
19/11/2012
Date of last data collection
Anticipated
Actual
21/12/2012
Sample size
Target
1640
Accrual to date
Final
1519
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237515 0
Government body
Name [1] 237515 0
National Health and Medical Research Council (NHMRC).
Country [1] 237515 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
School of Exercise and Nutrition Sciences
221 Burwood Highway
BURWOOD VIC 3125
Country
Australia
Secondary sponsor category [1] 236994 0
None
Name [1] 236994 0
Address [1] 236994 0
Country [1] 236994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243646 0
Deakin University Human Research Ethics Committee (EC00213)
Ethics committee address [1] 243646 0
Ethics committee country [1] 243646 0
Australia
Date submitted for ethics approval [1] 243646 0
10/08/2009
Approval date [1] 243646 0
19/10/2009
Ethics approval number [1] 243646 0

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

Contacts
Principal investigator
Name 30066 0
Address 30066 0
Country 30066 0
Phone 30066 0
Fax 30066 0
Email 30066 0
Contact person for public queries
Name 13313 0
Ms Lauren Arundell
Address 13313 0
Centre for Physical Activity and Nutrition Research (C-PAN)
School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy Burwood, Vic 3125
Country 13313 0
Australia
Phone 13313 0
+61 3 9251 7357
Fax 13313 0
+61 3 9244 6017
Email 13313 0
[email protected]
Contact person for scientific queries
Name 4241 0
Associate Professor Jo Salmon
Address 4241 0
Centre for Physical Activity and Nutrition Research (C-PAN)
School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy Burwood, Vic 3125
Country 4241 0
Australia
Phone 4241 0
+61 3 9251 7254
Fax 4241 0
+61 3 9244 6017
Email 4241 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
EmbaseIntervention effects on children's movement behaviour accumulation as a result of the Transform-Us! school- and home-based cluster randomised controlled trial.2022https://dx.doi.org/10.1186/s12966-022-01314-z
EmbaseIs level of implementation linked with intervention outcomes? Process evaluation of the TransformUs intervention to increase children's physical activity and reduce sedentary behaviour.2022https://dx.doi.org/10.1186/s12966-022-01354-5
N.B. These documents automatically identified may not have been verified by the study sponsor.