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Trial registered on ANZCTR


Registration number
ACTRN12616000980437
Ethics application status
Approved
Date submitted
18/07/2016
Date registered
26/07/2016
Date last updated
12/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Whole of Systems Trial Of Prevention Strategies for childhood obesity: WHO STOPS
childhood obesity
Scientific title
Whole of Systems Trial Of Prevention Strategies for childhood obesity: WHO STOPS
childhood obesity
Secondary ID [1] 289701 0
Nil
Universal Trial Number (UTN)
U1111-1185-4846
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 299516 0
Condition category
Condition code
Public Health 299493 299493 0 0
Other public health
Diet and Nutrition 299551 299551 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a quasi-experimental interventional study will be conducted over a five year period (2016-2021). We will conduct a stepped wedge cluster randomised trial in ten communities in the Great South Coast Region of Victoria.. Five communities will be randomised into the study in year one and all communities will be included in year 3. An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison and will help assess the potential diffusion of the intervention between regions within this trial. We will assess whether the adoption of systems change interventions rapidly increases community capacity to apply evidence-informed action across community systems. The primary outcome is childhood obesity prevalence and this will be collected by the community-led monitoring system already established with partners, AIs and CIs to this grant. In 2015, baseline data were collected from 3,000 children (90% participation rate (PR)) across the 10 study communities in the Great South Coast Region of Victoria, Australia. The intervention is intensive training and support within each intervention community oriented around strengthening the WHO systems building blocks (leadership, workforce development, resources, partners and networks,intelligence). This includes mapping existing systems and using these maps to develop whole of system change with community members (using the Group Model Building Process described below) and implementation support to optimize interventions. In each community the system intervention will be implemented with community members (parents and leaders from local government, education, clubs, agencies and business) with the jurisdiction or who can influence on environments in which children experience the key risk factors for obesity. Partners will convene new and existing coalitions of community leaders who have the authority, capacity, and networks to lead systems change across the community. These leaders have prioritized changing community systems to healthier food choices, physical activity and childhood obesity prevention. The workshops and evaluation sessions will be facilitated by a systems science specialist from Deakin University plus a number of other researchers from the Global Obesity Centre at Deakin University. Participants will be involved in the following activities over a 6-week period with follow up sessions every six months. 3hr Workshop 1: Background, evidence, plan presentation; fill in community capacity index; develop system logic model for ‘causes of childhood obesity in their community’ (outcomes evidence translation, baseline measurements, base systems model).3hr Workshop 2: Further evidence presentation; fill in social network analysis questionnaires; validation of system logic model on contextualised causes of childhood obesity constructed from the previous workshop (outcomes - further baseline data and knowledge translation and first validation of model). Half-day workshop: Steering Group recruits 100 champions from across the community who validate the systems logic model and identify priority actions for each sub-systems related to them (outcomes; wider community validation of model and action plans). 2-hour workshop: review the consolidated priority actions (outcomes; translate actions to institutional action plans). 1-2hr evaluation sessions: 6-monthly sessions to identify subsystem changes and modifications to the systems map (outcomes; follow up systems measures). Actions are developed and implemented by community working groups. Examples of community-led interventions include removing sugar sweetened beverages from health services, schools and local council workplaces; introducing healthy procurement processes for local governments; making drinking water freely accessible in public places; setting up no drive zones 800m from schools to encourage active transport. The community working groups are formed from the 100 community champions. These champions volunteer to any working group to which they have the time, remit and capacity to contribute.
Intervention code [1] 295329 0
Prevention
Intervention code [2] 295374 0
Lifestyle
Intervention code [3] 295375 0
Behaviour
Comparator / control treatment
A group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison and will help assess the potential diffusion of the intervention between regions within this trial.
Control group
Active

Outcomes
Primary outcome [1] 299032 0
Prevalence of childhood obesity, assessed using BMI-z score from height and weight measurements taken by trained research assistants using stadiometres and scales.
Timepoint [1] 299032 0
Data collection timepoints 2017 2019 2021
Secondary outcome [1] 325787 0
Composite outcome: Change in children’s PA and sedentary behaviours measured using validated surveys at each time point; the Modified Core Indicators and Measures of Youth Health and School Health Action, Planning and Evaluation System
Timepoint [1] 325787 0
At baseline (2015) and 2, 4 and 6 years post commencement of intervention at first clusters.
Secondary outcome [2] 325910 0
Change in physical activity, assessed using accelerometers worn for 7 days at each timepoint.
Timepoint [2] 325910 0
At baseline (2015) and 2, 4 and 6 years post commencement of intervention at first clusters.
Secondary outcome [3] 325912 0
Change in school environments will be measured using Environments will be measured using Environment audit tools.
The Schools Environmental Audit was developed for previous interventions from this group: Be Active Eat Well and It’s Your Move
Timepoint [3] 325912 0
At baseline (2015) and 2, 4 and 6 years post commencement of intervention at first clusters.
Secondary outcome [4] 325914 0
Change in health related quality of life in children will be measured using validated surveys;
Paediatric Quality of Life Inventory (PedsQL) and the CHU-9D Child Health Utility Index.
Timepoint [4] 325914 0
At baseline (2015) and 2, 4 and 6 years post commencement of intervention at first clusters.
Secondary outcome [5] 325987 0
Change in children’s diet behaviours measured using surveys at each time point using a validated survey; Modified Simple Dietary Questionnaire
Timepoint [5] 325987 0
At baseline (2015) and 2, 4 and 6 years post commencement of intervention at first clusters.

Eligibility
Key inclusion criteria
The intervention is community-wide and has no other inclusion criteria other than living in the community.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria for the intervention

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures - coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The intervention design is a step wedge; two intervention groups each of 5 clusters with delayed start.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The effect of the intervention on the main outcome (BMI-z) will be assessed using a linear mixed model with cluster as a random effect (community) and time (step), intervention and interaction of time*intervention as fixed effects. Because enrolment in intervention is staggered data will be analysed following two different approaches: 1) an intention to treat principle irrespective of when the enrolment effectively occurred; and 2) considering actual time enrolled. Secondary outcomes will be analysed by fitting a generalized linear mixed model with link and distribution selected according to the variable. Missing outcomes (we anticipate will be sparse due to the selection criteria “child present at school on the day of data collection”) will be managed using an inverse probability weighting approach.

Based on school enrolment data, we estimate that there are 4,757 children in the GSCRV in Grades 2, 4 or 6. Using an opt-out consent process, which delivers a 90% response rate, we expect to measure more than 3,000 children at each study wave in the 10 communities involved in the study. Taking a conservative approach, we expect at least 3,000 observations at each step and 9,000 across the three study data points. BMI-z standard deviation (1.2) and intra-cluster correlation (0.027) were estimated from our baseline external control study of >2,500 Victorian school children (2014-2015). Under the stepped wedge design (10 clusters, three data collection points, 5 clusters randomized to intervention at step one) and an average of 300 children in each cluster) the minimum detectable difference in BMI-z between groups with 80% power will be 0.13.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/05/2016
Date of last participant enrolment
Anticipated
29/03/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
3000
Accrual to date
1200
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13625 0
3305 - Portland
Recruitment postcode(s) [2] 13626 0
3300 - Hamilton
Recruitment postcode(s) [3] 13627 0
3250 - Colac
Recruitment postcode(s) [4] 13628 0
3260 - Camperdown
Recruitment postcode(s) [5] 13629 0
3280 - Warrnambool
Recruitment postcode(s) [6] 13630 0
3268 - Timboon
Recruitment postcode(s) [7] 13631 0
3264 - Terang
Recruitment postcode(s) [8] 13632 0
3284 - Port Fairy

Funding & Sponsors
Funding source category [1] 294085 0
Government body
Name [1] 294085 0
National Health and Medical Research Council
Country [1] 294085 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Geelong Waterfront Campus,
1 Gheringhap Street
Geelong, VIC 3220
Country
Australia
Secondary sponsor category [1] 292915 0
Other Collaborative groups
Name [1] 292915 0
Western Alliance
Address [1] 292915 0
c/o Department of Medicine, Barwon Health,
Myers House, Geelong,
PO Box 281, Geelong 3220
Victoria,
Country [1] 292915 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295501 0
Deakin University
Ethics committee address [1] 295501 0
Ethics committee country [1] 295501 0
Australia
Date submitted for ethics approval [1] 295501 0
04/08/2014
Approval date [1] 295501 0
07/10/2014
Ethics approval number [1] 295501 0
HEAG-H 155_2014

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

Contacts
Principal investigator
Name 67494 0
Prof Steven Allender
Address 67494 0
Deakin University
Waterfront Campus
1 Gheringhap Street
Geelong, Vic, 3220
Australia
Country 67494 0
Australia
Phone 67494 0
+61 3 522 78305
Fax 67494 0
Email 67494 0
steven.allender@deakin.edu.au
Contact person for public queries
Name 67495 0
Steve Allender
Address 67495 0
Deakin University
Waterfront Campus
1 Gheringhap Street
Geelong, Vic, 3220
Australia
Country 67495 0
Australia
Phone 67495 0
+61 3 522 78305
Fax 67495 0
Email 67495 0
steven.allender@deakin.edu.au
Contact person for scientific queries
Name 67496 0
Steve Allender
Address 67496 0
Deakin University
Waterfront Campus
1 Gheringhap Street
Geelong, Vic, 3220
Australia
Country 67496 0
Australia
Phone 67496 0
+61 3 522 78305
Fax 67496 0
Email 67496 0
steven.allender@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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWhole of systems trial of prevention strategies for childhood obesity: WHO STOPS childhood obesity.2016https://dx.doi.org/10.3390/ijerph13111143
EmbaseAssociations between combined overweight and obesity, lifestyle behavioural risk and quality of life among Australian regional school children: Baseline findings of the Goulburn Valley health behaviours monitoring study.2019https://dx.doi.org/10.1186/s12955-019-1086-0
EmbaseIs the physical activity environment surrounding primary schools associated with students' weight status, physical activity or active transport, in regional areas of Victoria, Australia? A cross-sectional study.2021https://dx.doi.org/10.1136/bmjopen-2020-045785
EmbaseGenerating change through collective impact and systems science for childhood obesity prevention: The GenR8 Change case study.2022https://dx.doi.org/10.1371/journal.pone.0266654
EmbasePotential Mediating Roles of Children's Health-Related Quality of Life and Weight-Related Behaviors in the Relationship Between Socio-Educational Advantage and Weight Status.2023https://dx.doi.org/10.1089/chi.2023.0054
N.B. These documents automatically identified may not have been verified by the study sponsor.