Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001235291
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
23/07/2018
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining children’s short-term responses to increases and decreases in physical activity
Scientific title
Examining children’s short-term activity compensatory responses to increases and decreases in physical activity
Secondary ID [1] 295385 0
None
Universal Trial Number (UTN)
Trial acronym
Reactivity to Activity (REACT) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 308618 0
Condition category
Condition code
Public Health 307567 307567 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this cross-over controlled experiment, children will complete three, one-off conditions in the school setting, each separated by at least a 7 day washout period. The three conditions are:
a) Additional moderate-to-vigorous physical activity: A single 90 minute sports class focusing on skills, fitness, and competitive games during class time. Activities undertaken during the sports class include soccer and basketball games, playground games, and dribbling, throwing and catching activities.
b) Additional light physical activity: A single 90 minute standing lesson delivered during class time. Easels and clipboards are provided in the classroom to facilitate the completion of class work whilst standing.
c) Restriction of light and moderate-to-vigorous activity: Children engage in seated indoor play activities during recess and lunchtime on one day. Indoor play activities include card and board games, reading, and drawing.

The experimental conditions will be delivered in a random order. The conditions are delivered on Tuesdays or Wednesdays in school to enable the monitoring of activity levels on the day of the session and the following day. All conditions are delivered and supervised by research staff, which includes qualified teachers.
Intervention code [1] 301703 0
Behaviour
Comparator / control treatment
Children will participate in their usual school week routine (Monday-Friday) to obtain a baseline measure of behaviour and activity levels a week before the first experimental condition.
Control group
Active

Outcomes
Primary outcome [1] 306546 0
Physical activity will be objectively assessed using hip-worn accelerometers, Children will wear the monitors during waking hours for 5 days (Monday-Friday). Time spent engaged in light-, moderate-, and vigorous-intensity physical activity will be calculated..
Timepoint [1] 306546 0
Each assessment period (baseline, experimental conditions). The experimental conditions will occur on Tuesday or Wednesday, and data will be collected for that school week (Monday-Friday).
Primary outcome [2] 306836 0
Sedentary time will be objectively assessed using hip-worn accelerometers, Children will wear the monitors during waking hours for 5 days (Monday-Friday). Time spent engaged in sedentary time will be calculated..
Timepoint [2] 306836 0
Each assessment period (baseline, experimental conditions). The experimental conditions will occur on Tuesday or Wednesday, and data will be collected for that school week (Monday-Friday
Secondary outcome [1] 348825 0
Sitting time: Children will wear inclinometers on their thigh for 5 consecutive days (Monday-Friday). Time spent sitting per day will be obtained.
Timepoint [1] 348825 0
Each assessment period (baseline, experimental conditions). The experimental conditions will occur on Tuesday or Wednesday, and data will be collected for that school week (Monday-Friday).
Secondary outcome [2] 348833 0
Behavioural information on the types of activities in which children participate will be collected using surveys designed for this study.
Timepoint [2] 348833 0
Each assessment period (baseline, experimental conditions). Survey data will be collected for each corresponding school week (Monday-Friday).
Secondary outcome [3] 348836 0
Daily energy expenditure: A sub-sample of children will wear an accelerometer on their upper arm for 5 consecutive days (Monday-Friday).
Timepoint [3] 348836 0
Each assessment period (baseline, experimental conditions). The experimental conditions will occur on Tuesday or Wednesday, and data will be collected for that school week (Monday-Friday).
Secondary outcome [4] 349761 0
Objectively-measured standing time: Children will wear inclinometers on their thigh for 5 consecutive days (Monday-Friday). Time spent standing per day will be obtained.
Timepoint [4] 349761 0
Each assessment period (baseline, experimental conditions). The experimental conditions will occur on Tuesday or Wednesday, and data will be collected for that school week (Monday-Friday).

Eligibility
Key inclusion criteria
Children in Years 4, 5 and 6 will be invited to participate.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no specific exclusion criteria for children participating in the study.

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)
The order in which the experimental conditions are delivered at school is randomised. This is conducted by an independent researcher. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple, manual randomisation method was used to determine the order of experimental condition delivery within schools. The conditions were drawn out of a hat by an independent researcher not associated with the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined using previous research examining compensatory changes in children's physical activity levels. There is sufficient statistical power (80%) to assess a small effect size in physical activity while adopting a two-tailed 5% probability level and adjusting for ~5 confounders.

Generalised linear latent and mixed models (GLLAMMs) accounting for clustering effects
at the class and participant levels will be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/09/2017
Date of last participant enrolment
Anticipated
3/05/2019
Actual
26/10/2018
Date of last data collection
Anticipated
28/06/2019
Actual
21/12/2018
Sample size
Target
270
Accrual to date
Final
368
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299977 0
Government body
Name [1] 299977 0
Australian Research Council (ARC)
Country [1] 299977 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University,
Institute for Physical Activity and Nutrition (IPAN),
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Hwy Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 299358 0
None
Name [1] 299358 0
Address [1] 299358 0
Country [1] 299358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300835 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 300835 0
Ethics committee country [1] 300835 0
Australia
Date submitted for ethics approval [1] 300835 0
27/04/2017
Approval date [1] 300835 0
30/05/2017
Ethics approval number [1] 300835 0
HEAG-H 54_2017

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

Contacts
Principal investigator
Name 84970 0
Dr Nicola Ridgers
Address 84970 0
Institute for Physical Activity and Nutrition (IPAN),
Deakin University,
221 Burwood Highway,
Burwood,
VIC 3125.
Country 84970 0
Australia
Phone 84970 0
+61 3 9244 6718
Fax 84970 0
Email 84970 0
[email protected]
Contact person for public queries
Name 84971 0
Abbe Moriarty
Address 84971 0
Institute for Physical Activity and Nutrition (IPAN),
Deakin University,
221 Burwood Highway,
Burwood,
VIC 3125.
Country 84971 0
Australia
Phone 84971 0
+61 3 9246 8951
Fax 84971 0
Email 84971 0
[email protected]
Contact person for scientific queries
Name 84972 0
Nicola Ridgers
Address 84972 0
Institute for Physical Activity and Nutrition (IPAN),
Deakin University,
221 Burwood Highway,
Burwood,
VIC 3125.
Country 84972 0
Australia
Phone 84972 0
+61 3 9244 6718
Fax 84972 0
Email 84972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will not be available at this point in time. Metadata will be made available for researchers.


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.