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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]

ISRCTN83725066

Universal Trial Number (UTN)

Trial acronym

Transform-Us!

Linked study record

Health condition

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

Physical activity in children

Diabetes risk in children

Sedentary behaviour in children

Cardiovascular disease risk in children

Condition category

Condition code

Public Health

Epidemiology

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Public Health

Health promotion/education

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).

Primary outcome [2]

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]

Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).

Secondary outcome [1]

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 [1]

Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).

Secondary outcome [2]

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]

Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).

Secondary outcome [3]

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 [3]

Baseline, 24 months (post-intervention), 36 months (12-months follow-up).

Secondary outcome [4]

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 [4]

Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).

Secondary outcome [5]

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]

Baseline, 12 months (mid-intervention), 24 months (post-intervention), 36 months (12-months follow-up).

Secondary outcome [6]

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 [6]

Baseline, 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]

Government body

Name [1]

National Health and Medical Research Council (NHMRC).

Address [1]

GPO Box 1421, Canberra ACT 2601
Level 5, 20 Allara Street, Canberra City ACT

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee (EC00213)

Ethics committee address [1]

Human Ethics Office, Research Services Division, Deakin University, 221 Burwood Hwy, Burwood VIC 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/08/2009

Approval date [1]

19/10/2009

Ethics approval number [1]

Summary

Brief summary

Schools within a within 50km of Melbourne may be invited to participate.

Trial website

Trial related presentations / publications

Publications	
1. Mine Yildirim, Lauren Arundell, Ester Cerin, Valerie Carson, Helen Brown, David Crawford, Kylie D Hesketh, Nicola D Ridgers, Saskia J te Velde, Mai JM Chinapaw, Jo Salmon. What helps children to move more at school recess and lunchtime? Mid-intervention results from Transform-Us! cluster-randomized controlled trial. British Journal of Sports Medicine. October 11, 2013.

2.	Barnett LM, Ridgers ND, Hanna L, Salmon J. Parents’ and children’s views on whether active video games are a substitute for the ‘real thing’. Qualitative Research in Sport, Exercise and Health. 2013:1-16

3.	Carson, V, Salmon, J, Arundell, L, Ridgers, N, Cerin, E, Brown, H, Hesketh, K, Ball, K, Chinapaw, M, Yildirim, M, Daly, R, Dunstan, D & Crawford, D. Examination of mid-intervention mediating effects on objectively assessed sedentary time among children in the Transform-Us! cluster-randomized controlled trial. International Journal of Behavioral Nutrition and Physical Activity, 2013 vol. 10, no. 1, p. 62.

4.	Arundell, L, Salmon, J, Veitch, J, O'Connell, E, Hinkley, T & Hume, C. Standardising the 'after-school' period for children's physical activity and sedentary behaviour. Health Promotion Journal of Australia, 2013 vol. 24, no. 1, pp. 65-7.

5.	Ridgers N, Salmon J, Ridley K, O'Connell E, Arundell L, Timperio A. Agreement between activPAL and ActiGraph for assessing children's sedentary time. International Journal of Behavioral Nutrition and Physical Activity, 2012. 9(1): p. 15.

6.	Salmon J, Arundell L, Hume C, Brown H, Hesketh K, Dunstan D, Daly R, Pearson N,Cerin E, Moodie M, Sheppard L, Ball K, Bagley S, Paw M, Crawford D. A cluster-randomized controlled trial to reduce sedentary behavior and promote physical activity and health of 8-9 year olds: the Transform-Us! study. BMC Public Health, 2011. 11: p. 759-759.

7.	Salmon J. Novel Strategies to Promote Children's Physical Activities and Reduce Sedentary Behavior. Journal of Physical Activity & Health 2010: 7: S299-S306.

8.	Salmon J, Hume C, Arundell L, Brown H, Hesketh K, Daly R, Dunstan D, Cerin E, Ball K, Crawford D. Reducing children’s sedentary time at school and at home (abstract). Journal of Science and Medicine in Sport (Supplement): 2009 12(6); p. 26.

Presentations
1.	Jo Salmon, Lauren Arundell, Nicky Ridgers, Ester Cerin, Helen Brown, Robin Daly, David Dunstan, Kylie Ball, David Crawford, Clare Hume, Mai Chinapaw, Lauren Sheppard, Marj Moodie, Kylie Hesketh. SBRN Sedentary Behaviour Symposium (accepted) . A cluster randomised controlled trial to reduce sedentary behaviour and promote physical activity and health of 8-9 year olds: Main findings from the Transform Us! Study. International Congress on Physical Activity and Public Health. Rio de Janeiro, Brazil. April 2014.
2.	Nicola D. Ridgers, Kylie D. Hesketh, Lauren Arundell, Anna Timperio, Trina Hinkley, Mai Chin A Paw, Ester Cerin, David W. Dunstan and Jo Salmon (accepted). Assessment of accelerometer non-wear time in children. ISBNPA 2014 San Diego, California, USA.May 2014.
3.	Jo Salmon, Lauren Arundell, Nicky Ridgers, Ester Cerin, Helen Brown, Robin Daly, David Dunstan, Kylie Ball, David Crawford, Clare Hume, Mai Chinapaw, Lauren Sheppard, Marj Moodie, Kylie Hesketh (accepted). A cluster randomised controlled trial to reduce sedentary behaviour and promote physical activity and health of 8-9 year olds: Main findings from the Transform Us! Study. ISBNPA 2014 San Diego, California, USA, May 2014.
4.	J. Salmon, V. Carson, M. Yildirim, L. Arundell, E. Cerin, M. Chinapaw, K. Hesketh, K. Ball, N. Ridgers, H. Brown, R.M. Daly, D.W. Dunstan, D Crawford. Preventing diabetes in children and adolescents: School- and family-based approaches to diabetes prevention. Int Diabetes Federation Conference, Melbourne, Dec 2013.
5.	Jo Salmon, Lauren Arundell, Helen Brown, Ester Cerin, Kylie Hesketh, David Crawford Mai Chin A Paw, Kylie Ball. Symposium: Parents’ engagement in an Australian school- and home-based group RCT to reduce children’s sitting time and promote physical activity: Transform-Us! ISBNPA 2013, Gent, June 2013. 
6.	Salmon J, Robinson S, Daly R, Dunstan D, Arundell L, Carson V, Ridgers ND. Symposium. Patterns of children’s sedentary and sitting time and metabolic health indicators: the Transform-Us! study. ISBNPA 2013 Gent, June 2013.
7.	Valerie Carson, Jo Salmon, Lauren Arundell, Kylie D. Hesketh, Kylie Ball, Robin M. Daly, David W Dunstan, David Crawford. Mid-intervention mediated effects on objectively assessed total sedentary time among children in the Transform-Us! intervention. ISBNPA 2013 Gent June 2013. 
8.	Lauren Arundell, Jo Salmon, Mine Yildirim, Ester Cerin, Kylie Hesketh, Kylie Ball, Helen Brown, Mai Chin A Paw, Clare Hume and David Crawford. Strategies to promote children’s school based physical activity: Transform-Us! Mid-intervention findings. Be Active. Sydney, Australia Nov 2012.

9.	Jo Salmon, Lauren Arundell, Helen Brown, Nicky Ridgers, Ester Cerin, Kylie Ball, Clare Hume, Mai Chin A Paw, Kylie Hesketh, David Crawford. Children’s Sitting Time at School and Home and What Parents Think about it. International Congress of Behavioral Medicine. Budapest, Hungary, Aug 2012.
10.	Jo Salmon, Lauren Arundell, Nicola D Ridgers. The contribution of class time to children's daily sitting time.ASBHM Melbourne, Feb 2012.
11.	Jo Salmon, Lauren Arundell, Helen Brown, Kylie Ball, Clare Hume, Kylie Hesketh, Ester Cerin, Mai Chin A Paw, David Crawford. Parental perceptions of the benefits of standing lessons and active homework tasks. ASBHM Melbourne, Feb 2012.
12.	Lauren Arundell, Jo Salmon, Jenny Veitch, Clare Hume. Associations between children’s after-school activity preference and after-school physical activity and sedentary behavior. ASBHM, Melbourne Feb 2012.
13.	Jo Salmon, Lauren Arundell, Robin Daly, David Dunstan and Sarah Robinson. Associations between sedentary and sitting time and 25-hydroxyvitamin d status among Australian 8-year olds. SMA, Fremantle June 2011.
14.	Lauren Arundell, Jo Salmon, Jenny Veitch, Clare Hume. Children’s sedentary behaviour during the after-school period. SMA, Fremantle, October 2011.
15.	Jo Salmon, Lauren Arundell, Robin Daly, David Dunstan and Sarah Robinson, Associations between sedentary and sitting time and 25-hydroxyvitamin d status among Australian 8-year olds (symposium). ISBNPA, Melbourne, June 2011.
16.	Lauren Arundell, Jo Salmon, Jenny Veitch, Clare Hume. Children’s health behaviours during the after-school period. ISBNPA, Melbourne, June 2011.
17.	Sarah Robinson, Jo Salmon, Clare Hume, Robin Daly. Objectively measured sedentary time and the association with waist circumference, cholesterol and blood pressure among 8 year old Australian children (Poster). ISBNPA, Melbourne, June 2011.
18.	Lauren Arundell, Jo Salmon, Jenny Veitch, Clare Hume, Eoin O’Connell. Defining the after-school period for children’s health behaviours (Poster), ISBNPA, Melbourne, June 2011.
19.	Helen Brown and Lauren Arundell. Intervention for reducing children’s sedentary behaviour at school & home: Transform-Us! VCAA Curriculum Branch presentation. East Melbourne, May 2010
20.	Jo Salmon. Novel Strategies to Promote Physical Activity & Reduce Sedentary Time among Children. International Society for Physical Activity and Health  ISPAH, Toronto, May 2010.
21.	Jo Salmon. Can obesity be prevented through reducing sedentary time? ANZOS Child Obesity Symposium, Sydney, 21-23 October 2010.
22.	Salmon J, Hume C, Arundell L, Brown H, Hesketh K, Daly R, Dunstan D, Cerin E, Ball K, Crawford D. Reducing children’s sedentary time at school and at home. Seventh National Physical Activity Conference, Brisbane, Australia, Oct 2009

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Ms Lauren Arundell

Address

Centre for Physical Activity and Nutrition Research (C-PAN)
School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy Burwood, Vic 3125

Country

Australia

Phone

+61 3 9251 7357

Fax

+61 3 9244 6017

lauren.arundell@deakin.edu.au

Contact person for scientific queries

Name

Associate Professor Jo Salmon

Address

Centre for Physical Activity and Nutrition Research (C-PAN)
School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy Burwood, Vic 3125

Country

Australia

Phone

+61 3 9251 7254

Fax

+61 3 9244 6017

jo.salmon@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

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Intervention effects on children's movement behaviour accumulation as a result of the Transform-Us! school- and home-based cluster randomised controlled trial.	2022	https://dx.doi.org/10.1186/s12966-022-01314-z
Embase	Is level of implementation linked with intervention outcomes? Process evaluation of the TransformUs intervention to increase children's physical activity and reduce sedentary behaviour.	2022	https://dx.doi.org/10.1186/s12966-022-01354-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

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