ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1185-4846

Trial acronym

Linked study record

Health condition

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

Childhood obesity

Condition category

Condition code

Public Health

Other public health

Diet and Nutrition

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

Data collection timepoints 2017 2019 2021

Secondary outcome [1]

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]