Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002008202
Ethics application status
Approved
Date submitted
11/12/2018
Date registered
14/12/2018
Date last updated
5/09/2019
Date data sharing statement initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Life on Holidays: How do changes in diet and activity during school term and the summer holidays relate to changes in fitness and fatness in school children?
Scientific title
Life on holidays: a 3 year longitudinal study tracking changes in South Australian primary school children's fitness and fatness during the in-school versus summer holiday period
Secondary ID [1] 294115 0
Nil known
Universal Trial Number (UTN)
U1111-1209-6266
Trial acronym
LoH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fitness 306707 0
Fatness 306708 0
Condition category
Condition code
Public Health 305807 305807 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will occur in 2 phases, an initial pilot phase followed by the main study. During the initial pilot phase 3 schools wil be recruited. This phase will be used to refine precedures for effective running of the main study, and be conducted over a shortened time period from June to November 2018.

The main study will commence in at start of the 2019 school year (Jan/Feb). This study will explore changes in children's fitness and fatness during in-school and summer holiday periods over three successive years and relate these changes to changes in diet and activity patterns. This study will also assess cross-sectional and longitudinal associations of diet and activity patterns with academic achievement.

Activity patterns will be assessed in school hours for beginning (Term 1) and end of year (Term 4) assessments, and via telephone for summer holiday assessments. Diet assessments will be administered outside of normal school hours. Assessments of diet and activity patterns will be conducted at the beginning and end of each school year (Term 1 and Term 4), and once during each summer holiday period (December/January).

Activity patterns will be assessed using both objective and self-report measures. GENEActiv accelerometers will be used to provide an objective measure of time spent sleeping, sitting and in light-, moderate- and vigorous- intensity physical activity. These devices will be worn 24 hours/day for 7 consecutive days. The GENEActiv accelerometer has excellent convergent validity (r=0.98) when compared to other accelerometers, as well as good test-retest reliability (ICC=0.67–0.87). Data will be collected at 50 Hz and collapsed into 60-s epochs. The cutpoints identified by Phillips et al. will be used to identify time spent sedentary, and in each intensity of physical activity. Participants’ accelerometry data will be included in analyses if they wear the accelerometer for at least 10 waking hours, on at least three weekdays and one weekend day. The Multimedia Activity Recall for Children and Adults (MARCA) will be used to provide a valid (r=0.4–0.7) and reliable (ICC=0.88–1.00) measure of time spent in specific types of activity. During one 30-minute computer-assisted telephone interview, participating children will recall every activity (e.g. sports, reading, household chores) they did over a 2-day period each time. Each activity is linked to a compendium of energy expenditures so that overall and activity-specific energy costs can be estimated.

Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24), Australian version (2016), developed by the National Cancer Institute, Bethesda, MD, United States. This is an online tool for collecting 24-hour dietary recall data. The ASA24 will be interviewer administered. At each study time point, parents/carers will complete the ASA24 on one occasion (~30 minutes/recall). The Australian Food Supplement and Nutrient Database (AUSNUT) 2011 will be used to estimate food group intake, energy and nutrient intake. Usual energy and macronutrient intake will be derived using the web-based statistical modelling technique Multiple Source Method.
Intervention code [1] 300392 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304871 0
Percent body fat will be measured via InBody 270 Bioelectrical Impedance Analyser (BIA) scales (InBody Co., Ltd, USA). This measure will be taken twice. A third measure will be taken if there is more than 1.0% difference between the first and second measurements, with the mean of two or median of three measurements used in the analyses. The InBody BIA has evidence of validity (r=0.69–0.79 for children of this age) and reliability (CVintra=3%).
Timepoint [1] 304871 0
Percentage body fat will be measured during Term 1 and during Term 4 of each school year (i.e. within 10 weeks of the start and end of the school year).
Primary outcome [2] 304872 0
Fitness
Fitness will be measured using a composite score calculated as the average z-scores for 20-m shuttle run and standing broad jump. The 20-m shuttle run test (Australian Sports Commission) will be used to provide a measure of aerobic fitness. This test involves children running continuously between two lines 20 metres apart, to the pace of an audio beep. The test ends when the child can no longer keep up with the pace of the beep for two consecutive laps. The shuttle run test has evidence of validity (r=0.78) and reliability (r=0.78–0.93), compared with indirect calorimetry. Explosive lower body strength will be measured using a standing broad jump test. This test involved the child jumping as far forward as possible from a standing position. The best of three jump attempts will be used in analyses. The standing broad jump test has very high test-retest reliability among children aged 5 to 12 years (ICC=0.88). This test is also strongly associated with other lower body muscular strength tests (R2=0.83–86), as well as with upper body muscular strength tests (R2=0.69–0.85).
Timepoint [2] 304872 0
Fitness will be measured during Term 1 and during Term 4 of each school year (i.e. within 10 weeks of the start and end of the school year).
Secondary outcome [1] 343429 0
Academic achievement will be assessed using the school-administered Progressive Achievement Test (PAT) in mathematics and reading comprehension. These standardised tests developed for the Australian school context are designed to assess content of the Australian national curriculum. PAT mathematics and reading comprehension tests are compulsory for children attending Australian Government schools and form a part of routine testing in many Catholic and Independent schools. The PAT mathematics test covers content across the six strands of number, algebra, geometry, measurement, statistics and probability. This test takes 40 minutes to complete and consists of 35 (Grades 4 and 5) to 40 questions (Grade 6). The PAT reading comprehension test assesses retrieving and interpreting information and assessing texts. The test takes 40-minutes to complete and consists of 30 (Grade 4), 34 (Grade 5) and 35 questions (Grade 6).
Timepoint [1] 343429 0
Pilot study
Academic achievement will be measured once during one in-school period.

Main study
Academic achievement will be measured once per year over 3 successive years (during term 3 to align with Government mandated testing times).
Secondary outcome [2] 374555 0
Body mass index (BMI) will be derived from measured height and weight using the World Health Organisation Child Growth Standards. Height and weight will be obtained using a Seca 213 stadiometer (Hamburg, Germany) and InBody BIA scales (InBody Co., Ltd, USA), respectively. This measure will be taken twice. A third measure will be taken if there is more than 0.5cm or 0.5kg difference between the first and second measurements, with the mean of two or median of three measurements used in the analyses.
Timepoint [2] 374555 0
BMI will be measured at the start (Term 1) and end (Term 4) of each school year.
Secondary outcome [3] 374556 0
Waist circumference will be measured using a steel Lufkin W606PM anthropometric tape held at the midpoint between the bottom of the rib cage and the top of the iliac crest. This measure will be taken twice. A third measure will be taken if there is more than 0.5cm difference between the first and second measurements, with the mean of two or median of three measurements used in the analyses.
Timepoint [3] 374556 0
Waist circumference will be measured at the start (Term 1) and end (Term 4) of each school year.

Eligibility
Key inclusion criteria
Participants will initially be enrolled in Grade 4 classes at a participating Government, Catholic or Independent school in the Adelaide metropolitan area.


Minimum age
9 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Hypothesis 1 (Whether rates of change in fitness and fatness differ between in-school and summer holiday periods) will be analysed using linear mixed effects modelling, with the rate of change in fitness and fatness scores across the in-school period and holiday period fitted as marginal fixed-slope effects, with age, sex and weight status (where appropriate), as covariates and random intercept and slope coefficients for student, class and school to account for repeated measurements and clustering at different levels of the hierarchy.

Differences between rates of change during in-school (S) and holiday (H) periods will be calculated using model parameter estimate contrasts. We will test Hypothesis 2 (Whether the difference between in-school and summer holiday rates of change in fitness and fatness differ by SEP (familial level), sex and weight status)) using similar model parameter estimate contrasts from the linear mixed effects models, with S–H as the dependent variable, and SEP, sex and weight status as the grouping factors (individually and conjointly), and age, sex and weight status where appropriate as covariates.

Rates of change in outcomes during in-school periods will be operationalised as the change per unit time between the February and December measurements. Rates of change in the summer holiday period will be operationalised as the change per unit time between the point where the fitted line connecting the February and December measurements intersects with the start of the summer holidays, and the point where the fitted line connecting the February and December measurements of the following year intersects with the end of the summer holidays of the previous year. This procedure estimates the unmeasured change between the December measurement and the end of the school term, and between the start of the school term and the February measurement.

Use of time will be quantified as activity compositions, using both accelerometry-determined energy expenditure bands (sleep, sitting, light, moderate and vigorous PA) and MARCA activity superdomains (e.g. chores, physical activity, school). Compositions will be expressed as isometric log ratios to enable their inclusion in the linear mixed effects models. Differences in rates of change in outcome variables will be regressed against differences between the in-school composition and the holiday composition to test Hypothesis 3 (whether differences in rates of change in fitness and fatness between in-school and summer holiday periods will be associated with differences in diet and activity composition between in-school and holiday periods). Compositional isotemporal substitution analysis will allow us to quantify the change in fitness and fatness of replacing a given quantum of one component of the activity composition (e.g. 30 min of sitting) with the same quantum of another (e.g. 30 min of MVPA), while holding the remaining components constant. A similar analysis will be performed for diet, with macronutrient mix or food group intake as the composition, and total energy intake as a covariate.

Cross-sectional and longitudinal assoications of diet and activity patterns with academic achievement will be assessed using linear regression. Analyses will adjust for age, sex, SEP, parenting style, weight status and pubertal status.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/06/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
300
Accrual to date
228
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 298748 0
Government body
Name [1] 298748 0
NHMRC - Project Grant
Country [1] 298748 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
108 North Terrace, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 297931 0
None
Name [1] 297931 0
Address [1] 297931 0
Country [1] 297931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299687 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 299687 0
Ethics committee country [1] 299687 0
Australia
Date submitted for ethics approval [1] 299687 0
22/03/2018
Approval date [1] 299687 0
17/05/2018
Ethics approval number [1] 299687 0
Ethics committee name [2] 299692 0
Department for Education and Child Development
Ethics committee address [2] 299692 0
Ethics committee country [2] 299692 0
Australia
Date submitted for ethics approval [2] 299692 0
30/04/2018
Approval date [2] 299692 0
27/06/2018
Ethics approval number [2] 299692 0
Ethics committee name [3] 299693 0
Adelaide Catholic Education Centre
Ethics committee address [3] 299693 0
Ethics committee country [3] 299693 0
Australia
Date submitted for ethics approval [3] 299693 0
30/04/2018
Approval date [3] 299693 0
26/06/2018
Ethics approval number [3] 299693 0

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

Contacts
Principal investigator
Name 81298 0
Prof Timothy Olds
Address 81298 0
Alliance for Research in Exercise Nutrition and Activity (ARENA)
Sansom Institute
School of Health Sciences
University of South Australia
City East Campus, 108 North Terrace, Adelaide SA 5001
Country 81298 0
Australia
Phone 81298 0
+61 8 830 21411
Fax 81298 0
Email 81298 0
[email protected]
Contact person for public queries
Name 81299 0
Timothy Olds
Address 81299 0
Alliance for Research in Exercise Nutrition and Activity (ARENA)
Sansom Institute
School of Health Sciences
University of South Australia
City East Campus, 108 North Terrace, Adelaide SA 5001
Country 81299 0
Australia
Phone 81299 0
+61 8 830 21411
Fax 81299 0
Email 81299 0
[email protected]
Contact person for scientific queries
Name 81300 0
Timothy Olds
Address 81300 0
Alliance for Research in Exercise Nutrition and Activity (ARENA)
Sansom Institute
School of Health Sciences
University of South Australia
City East Campus, 108 North Terrace, Adelaide SA 5001
Country 81300 0
Australia
Phone 81300 0
+61 8 830 21411
Fax 81300 0
Email 81300 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


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.