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Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND)

Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND): a cluster randomised controlled trial in Victorian communities

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001986268
Acronym
RESPOND
Enrollment
3750
Registered
2018-12-11
Start date
2019-03-27
Completion date
2023-06-30
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Community leaders in ten local government areas in Victoria’s north-east will take part in an innovative program to reduce the region’s childhood obesity rates, in partnership with Deakin University’s Global Obesity Centre. The initiative – called RESPOND – will work with each of the communities in driving positive and practical changes from the ground up, to make them world leaders in promoting healthy weight among children. Over the next five years, RESPOND will engage with 14 of the region’s health services and 116 schools, reaching more than 30,000 children aged up to 12 years.

Interventions

This is a stepped-wedged cluster randomised controlled trial to be conducted over five years (2018 to 2023). The study will be conducted across 10 local government areas in the north-east of Victoria, Australia. Five local government areas have been randomised into the study for Step 1 (2018-2019), the remaining five local government areas have been randomised into step 2 (2021-2023). This research will assess whether the adoption of systems change interventions increase community capacity (s

This is a stepped-wedged cluster randomised controlled trial to be conducted over five years (2018 to 2023). The study will be conducted across 10 local government areas in the north-east of Victoria, Australia. Five local government areas have been randomised into the study for Step 1 (2018-2019), the remaining five local government areas have been randomised into step 2 (2021-2023). This research will assess whether the adoption of systems change interventions increase community capacity (specifically community knowledge, engagement, resources and networks) in the application of community-led intervention activity across community systems. The RESPOND intervention comprises FIVE components. These are: 1. Systems approach capacity building; a. Face-to-face training b. Online support 2. Community-led intervention activity; 3. School Monitoring System and analysis of weight status of infants and young children aged 2 and 3.5 years (via de-identified Maternal and Child Health Data) 4. Knowledge, engagement and social network analyses; 5. Collaborative Governance and Implementation Structure (Collective Impact); each is now outlined in more detail. 1a. Systems approach capacity building intervention: Stage 1 of the intervention will train local community leaders to facilitate group model building (GMB) workshops for the purpose of developing locally relevant causal loop diagrams (CLD) of determinants of obesity and how these determinants interlink. This will be conducted in two phases: a. Face-to-face training of community leaders in systems thinking approaches will be conducted in the communities. Our particular approach utilises community-based system dynamics and group model building. b. This face-to-face training will be strengthened and further supported through on-line training, also conducted by staff of the Global Obesity Centre at Deakin University (DU). This training (a and b) will build capacity of these community leaders to facilitate group model building (GMB) workshops with their communities to identify locally relevant drivers of obesity and build causal loop diagrams. The GMB sessions that community members facilitate can be localised to community context under guidance of staff from the Global Obesity Centre at Deakin University (DU) and are typically conducted over three workshop sessions: Workshop 1 (2 to 3 hrs): Invites key stakeholders from diverse organizations, it includes relevant background to the overall work of RESPOND, and an introduction to community based system dynamics, particularly group model building (GMB). This workshop will produce an initial causal loop diagram (CLD) of the local physical activity and healthy eating system. The workshop takes the form of a series of guided activities, facilitated by a small team of people being trained in the online sessions and involving up to 20 stakeholders. During the guided activities, participants are introduced to the nature and scope of the problem being investigated, work to identify the various factors contributing to the problem over time, and finally identify the interconnections between those factors. Throughout the discussion, facilitators make written notes of the general discussion and points raised by participants. Post workshop 1, facilitators work with DU staff to further develop and refine the CLD. Workshop 2 (2 to 3 hrs): Participants from the initial GMB workshop are invited to return for a second workshop, where the revised CLD will be presented. Participants are led through an abbreviated version of the Step 1 process, to validate and finalise the revised CLD. Workshop 3 (2 to 3 hrs): Community session: Members of the community are invited to a forum where they will be guided through reading and understanding the CLD. This broader group will review the developed CLD, brainstorm action ideas to address the problem of obesity relevant to their local context, and commit to taking action. 1b. Online support: The 10-session online support is offered by DU staff to the trained facilitators who have attended the face-to-face training (1a). These trained facilitators will conduct the Workshops 1 to 3 outlined above in their own communities. This online support will be offered concurrently with the workshops being conducted within communities. 2. Community-led intervention activity Actions are developed and implemented by community members forming a locally relevant coalition (perhaps short or longer term working groups). Examples of actions may include removal of sugar sweetened beverages from health services, or increasing the availability of healthy food options in food premises, or improvements to physical activity infrastructure. DU is available to provide evidence-informed advice to complement and support these activities but is not involved in the conduct of these interventions. 3. School monitoring system: The monitoring of BMIz of school-aged children (Yrs 2, 4 and 6) and selected health behaviours and in the 10 local government areas covered by the study. The RESPOND School Monitoring proposal aims to evaluate the impact of community led systems intervention to address childhood weight status and related behaviours. In addition, the RESPOND School Monitoring proposal aims to unpack implementation, cost and evaluation considerations required for the universal delivery of a childhood obesity monitoring system at scale. The 10 local government areas within the study, all of which are within the Goulburn Valley and Ovens Murray Region of North East Victoria will be invited to join the school monitoring proposal. There are 179 primary schools across this region. This monitoring is a repeat cross-sectional observation study within the wider RESPOND cluster randomised control trial. School Monitoring will be conducted across Term 1 and 2 (Feb-June) in each of the three monitoring waves (2019, 2021 and 2023). At the 2016 Census there were 28,865 children aged 5-12 years enrolled in these schools. Our study plans to recruit children in Grade 2, Grade 4 and Grade 6, we estimate a maximum population of 12,371. Across the three waves of data collection this reflects a maximum of 37,113 children as participants. The monitoring involves: a. Students in Year 2, Year 4 and Year 6 will be invited to have their height and weight measured in a private area by trained researchers (2-3 mins) per child. b. Students in Year 4 and Year 6 will be invited to complete a self-report electronic questionnaire on their physical activity, sedentary behaviours, diet intake, sleep and wellbeing (approx. 30 mins) in class-time. Additionally, a sub-sample of these students will be invited to wear an activity monitor (ActiGraph wGT3X-BT) (like a fitbit) for the next 7-days on their wrist (non-dominant hand). Data will also be collected via a school environment audit from leader in each school community. Early years The weight status of infants and young children aged 2 and 3.5 years will be calculated from previously obtained de-identified Maternal and Child Health Data. 4. Knowledge, engagement and social network analyses: Online surveys will be conducted to collect data on changes over time in knowledge and engagement with the issue of childhood obesity and in changes to social networks over time relevant to childhood obesity. 5. Collaborative Governance and Implementation Structure (Collective Impact) The RESPOND intervention comprises four Primary Care Partnerships, 10 local governments, up to 179 primary schools and multiple community partners. Therefore an overarching collaborative framework will be applied to this work. The Collective Impact Framework utilises five core conditions: common agenda, mutually reinforcing activities, shared measurement system, continuous communication and a backbone governance structure. These five conditions will guide the implementation, evaluation and governance of these collaborative efforts and will be supported by DU and local collaborators.

Sponsors

Deakin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
Yes

Inclusion criteria

There are several inclusion criteria related to different intervention components: The overall inclusion criteria is at 'community' level, rather than individual level in the first instance. The principal inclusion criteria are: Communities that are included within the geographical area represented by the RESPOND NHMRC funded grant. At an individual level, any person of any age who lives, works or attends school in any of the RESPOND catchment areas are eligible for inclusion. These 10 local government areas in Victoria are: 1. Strathbogie 2. Murrundindi 3. Mansfield 4. Indigo 5. Wodonga 6. Mitchell 7. Benalla 8. Wangaratta 9. Alpine 10. Towong Intervention Stage 1: Systems approach capacity building: community leaders and community members. This will include nominated employees within partner agencies named on the NHMRC funded grant (Primary Care Partnerships) and other community members, employed or volunteers who choose to be part of the RESPOND project. Intervention Stage 2: Community-led intervention activity: Community members will self-select into prioritised activities that arise from the GMB 3 workshop. There is no specific exclusion criteria. Intervention Stage 3: School monitoring System and MCH data: Inclusion criteria: primary school-aged children in either Grades 2, 4 and 6 who attend one of the 116 schools in the area, A total of 8,196 children. School Principals will be approached by letter, email and phone to participate in the monitoring. Subsequent inclusion criteria is currently reliant on an submitted ethics application for an opt-out approach for recruitment at student level. De-identified data will be obtained from the centralised Maternal and Child Health database on the infant weight status of up to 11,000 children per year. Intervention Stage 4: Knowledge, engagement and social network analyses. The published Knowledge Engagement and Networks tool will be used for data collection. (Korn AR, et al Development and testing of a novel survey to assess Stakeholder-driven Community Diffusion of childhood obesity prevention efforts. BMC Public Health. 2018). Inclusion: All members of the RESPOND regional partners group will be invited to complete this Knowledge, Engagement and Network Survey. All participants of GMB sessions 1, 2 and 3 will also be invited to complete the survey. The final question on the survey asks participants to provide their email addresses if they are willing to be contacted again to complete the survey. If email addresses are provided, this will constitute the inclusion criteria for future surveys. Initial recruitment is via third party partner agencies. All members of the governance structures and attendees at GMB 1, 2 and 3 will be invited by the workshop facilitators to complete the initial Knowledge, Engagement, Networks Survey. Intervention Stage 5: Establishment of Government and Implementation Structures Key inclusion criteria: Partner Agencies on the NHMRC grant, community members of the 10 LGAs within the RESPOND catchment.

Exclusion criteria

There are no specific exclusion criteria other than participants must live, work or attend school within the defined catchment of the RESPOND intervention. As many of the included communities are on the border of NSW, there may be 'spillover' effects. The research team will not work directly with or evaluate any activity in neighbouring communities.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026