Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001335189
Ethics application status
Approved
Date submitted
9/09/2019
Date registered
30/09/2019
Date last updated
30/09/2019
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Built Environment Changes on Active Transport to School among Adolescents (BEATS-2 Study)
Scientific title
Built Environment Changes and Active Transport to School among Adolescents: BEATS Natural Experiment
Secondary ID [1] 299227 0
None
Universal Trial Number (UTN)
U1111-1239-9113
Trial acronym
BEATS-NE
Linked study record
BEATS Natural Experiment is an extension of the original BEATS Study (Mandic S et al. 2016) which collected data from adolescents in Dunedin, New Zealand in 2014-2015 and provides baseline data for BEATS Natural Experiment.

Mandic S, Williams J, Moore A, Hopkins D, Flaherty C, Wilson G, García Bengoechea E, Spence JC. Built Environment and Active Transport to School (BEATS) Study: protocol for a cross-sectional study. BMJ Open. 2016;6:e011196. DOI: https://doi.org/10.1136/bmjopen-2016-01119

Health condition
Health condition(s) or problem(s) studied:
physical activity 314349 0
Condition category
Condition code
Public Health 312687 312687 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The built environment changes in Dunedin, New Zealand, that began in 2014 included changes in the cycling and pedestrian infrastructure include both macro-scale features (e.g., building of new cycle lanes, creation of quiet streets) and micro-scale features (improvement in intersection design, pedestrian infrastructure, safety features (traffic calming measures and aesthetics). The neighbourhoods of six out of 12 secondary schools in Dunedin, New Zealand, are affected with these built environment changes. Those schools will be considered "intervention" or "exposure" schools. Those built environment changes occurred regarding of whether the BEATS Natural Experiment Study was conducted or not.
Baseline data collection was completed in 2014-2015. Environmental scan of the school neighbourhoods of all 12 Dunedin secondary schools was completed between September 2017 and January 2018 (Pocock et al., 2019). The BEATS Natural Experiment follow-up assessments including the student survey, accelerometer assessments and mapping will be conducted in 2020. Focus groups will be conducted in 2021.

Reference: Pocock T, Moore A, Keall M, Mandic S. Physical and Spatial Assessment of School Neighbourhood Built Environments for Active Transport to School in Adolescents from Dunedin (New Zealand). Health & Place. 2019;55:1-8. (Epub: 13 Nov 2018); DOI: https://doi.org/10.1016/j.healthplace.2018.10.003
Intervention code [1] 315678 0
Not applicable
Comparator / control treatment
The six Dunedin secondary schools that did not have built environment changes in the cycling and pedestrian infrastructure in their neighbourhood since 2014 will be considered "control" schools.
Control group
Active

Outcomes
Primary outcome [1] 321338 0
Proportion of adolescents usually travelling to school using active transport (i.e. walking and/or cycling to school). Adolescents will self-report their mode of travel to school as part o the BEATS Student Survey completed online survey at the time of data collection. BEATS Student Survey has been designed specifically for this study. All questions
have been developed for use in school students, and most have been validated and used successfully in similar populations.

Survey items used for assessing transport to school among adolescents have been described in detail in our published journal article (Mandic et al, 2017).
Mandic S, Hopkins D, García Bengoechea E, Flaherty C, Williams J, Sloane L, Moore A, Spence JC. Adolescents’ perceptions of cycling versus walking to school: Understanding the New Zealand context. Journal of Transport & Health. 2017;4:294-304 DOI: http://dx.doi.org/10.1016/j.jth.2016.10.007
Timepoint [1] 321338 0
Follow-up adolescent survey data will be collected in 2020 which will be 5-6 years after baseline data were collected from adolescents in the same schools in 2014-2015.
Secondary outcome [1] 374698 0
Proportion of adolescents meeting physical activity guidelines using self-report. All adolescents participating in the study will self-report their physical activity as part of the online questionnaire using a validated question from the Health Behaviour in School Children (HBSC) survey (Currie at al., 2008). Briefly, moderate-to-vigorous physical activity will be assessed using the question “Over the past 7 days, on how many days were you physically active for a total of at least 60 minutes per day?”(Currie at al., 2008). A threshold value of 60 or more minutes of moderate-to-vigorous physical activity per day will be used to identify adolescents meeting physical activity guidelines (World Health Organisation, 2010).



Currie C, Nic Gabhainn S, Godeau E, et al. The Health Behaviour in School-aged Children: WHO Collaborative Cross-National (HBSC) study: origins, concept, history and development 1982-2008. Int J Public Health. 2009;54(Suppl 2):131-139.

World Health Organization (WHO). Global Recommendations on Physical Activity for Health. Geneva, Switzerland: WHO Press; 2010.
Timepoint [1] 374698 0
Follow-up adolescent survey data will be collected in 2020 which will be 5-6 years after baseline data were collected from adolescents in the same schools in 2014-2015.
Secondary outcome [2] 375295 0
Proportion of adolescents meeting physical activity guidelines using objectively measured physical activity. A subset of 420 adolescents will be provided an accelerometer (ActiGraph, GT3XPlus, Pensacola, FL, USA) to wear for one week approximately one to three weeks after completing the survey using a previously published protocol (Kek et al., 2019). An accelerometer assessment of physical activity will include assessment of light, moderate and vigorous intensity physical activity as well as time spent sedentary. A threshold value of 60 or more minutes of moderate-to-vigorous physical activity per day will be used to identify adolescents meeting physical activity guidelines (World Health Organisation, 2010).

Kek CC, García Bengoechea E, Spence J, Mandic S. The relationship between transport-to-school habits and physical activity in a sample of New Zealand adolescents. Journal of Sport and Health Science (in press; E-pub: 28 Feb 2019) DOI: https://doi.org/10.1016/j.jshs.2019.02.006

World Health Organization (WHO). Global Recommendations on Physical Activity for Health. Geneva, Switzerland: WHO Press; 2010.
Timepoint [2] 375295 0
Follow-up accelerometer data will be collected in 2020 which will be 5-6 years after baseline data were collected from adolescents in the same schools in 2014-2015.

Eligibility
Key inclusion criteria
Adolescents of both genders attending one of the 12 Dunedin secondary schools at the time of the data collection. Age 13 to 18 years.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Adolescents without signed consent and those with invalid consent for participation in this study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To examine the associations between active transport to school and the exposure (built environment changes), we will use multilevel logistic models with a binary outcome (active travel or not) to estimate rates of walking and cycling to school. Explanatory factors will include the exposure (or for the controls, no exposure), distance to school and time period (baseline or post-exposure). Gender will be considered a moderator. Exposure effects will be determined from the coefficient of the interaction term between time period and exposure status. The regression models will also examine the effects of parental attitudes (as reported by adolescents), season, school neighbourhood topography (hillside/flat) and schools’ decile on active transport to school rates. To address the various threats to the validity of a natural experiment, we are using a robust design with pre- and post- measurements of both exposed and unexposed groups. At baseline (2014/2015), ~40% of adolescents used some form of active transport to school (alone or with motorised transport). Some students will live in neighbourhoods with built environment improvements but attend control schools. We will conduct sensitivity analyses excluding such students, and another analysis looking at the shortest route to school as an exposure at the student level (which may have benefitted from built environment improvements, or not). Using multi-level models (such as GLIMMIX in SAS), we will also examine differences in adolescents’ perceptions and levels of physical activity as measured by the accelerometers for adolescents in the ‘exposure’ and ‘control’ schools. The latter analysis will also provide estimates of the contribution provided by active transport to school to overall physical activity for this group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2020
Actual
Date of last participant enrolment
Anticipated
30/11/2021
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment outside Australia
Country [1] 21850 0
New Zealand
State/province [1] 21850 0
Otago

Funding & Sponsors
Funding source category [1] 303764 0
Government body
Name [1] 303764 0
The Health Research Council of New Zealand
Country [1] 303764 0
New Zealand
Funding source category [2] 303765 0
University
Name [2] 303765 0
Division of Sciences, University of Otago
Country [2] 303765 0
New Zealand
Funding source category [3] 303766 0
University
Name [3] 303766 0
School of Physical Education, Sport and Exercise Sciences, University of Otago
Country [3] 303766 0
New Zealand
Primary sponsor type
Individual
Name
Sandra Mandic
Address
Active Living Laboratory
School of Physical Education, Sport and Exercise Sciences
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 303888 0
None
Name [1] 303888 0
Not applicable.
Address [1] 303888 0
Not applicable.
Country [1] 303888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304287 0
University of Otago Human Ethics Committee
Ethics committee address [1] 304287 0
Ethics committee country [1] 304287 0
New Zealand
Date submitted for ethics approval [1] 304287 0
28/11/2017
Approval date [1] 304287 0
14/12/2017
Ethics approval number [1] 304287 0
Ref num: 17/188

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

Contacts
Principal investigator
Name 96402 0
A/Prof Sandra Mandic
Address 96402 0
Active Living Laboratory
School of Physical Education, Sport and Exercise Sciences
PO Box 56
Dunedin 9054
New Zealand
Country 96402 0
New Zealand
Phone 96402 0
+64 3 4795415
Fax 96402 0
Email 96402 0
[email protected]
Contact person for public queries
Name 96403 0
Sandra Mandic
Address 96403 0
Active Living Laboratory
School of Physical Education, Sport and Exercise Sciences
PO Box 56
Dunedin 9054
New Zealand
Country 96403 0
New Zealand
Phone 96403 0
+64 3 4795415
Fax 96403 0
Email 96403 0
[email protected]
Contact person for scientific queries
Name 96404 0
Sandra Mandic
Address 96404 0
Active Living Laboratory
School of Physical Education, Sport and Exercise Sciences
PO Box 56
Dunedin 9054
New Zealand
Country 96404 0
New Zealand
Phone 96404 0
+64 3 4795415
Fax 96404 0
Email 96404 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
Due to sensitivity of the collected data, BEATS-NE data will not be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4670Study protocolJournal article describing the details of the study protocol is currently in preparation and will be submitted for publication in an open-access journal by the end of 2019. [email protected]
4671Informed consent form https://www.otago.ac.nz/beats/index.html[email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBuilt environment changes and active transport to school among adolescents: BEATS Natural Experiment Study protocol.2020https://dx.doi.org/10.1136/bmjopen-2019-034899
N.B. These documents automatically identified may not have been verified by the study sponsor.