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Trial registered on ANZCTR


Registration number
ACTRN12618001986268
Ethics application status
Approved
Date submitted
21/11/2018
Date registered
11/12/2018
Date last updated
8/08/2019
Date data sharing statement initially provided
11/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND)
Scientific title
Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND): a cluster randomised controlled trial in Victorian communities
Secondary ID [1] 294589 0
NHMRC APP1132792
Universal Trial Number (UTN)
U1111-1212-3081
Trial acronym
RESPOND
Linked study record
not applicable

Health condition
Health condition(s) or problem(s) studied:
Obesity 307388 0
Condition category
Condition code
Diet and Nutrition 306485 306485 0 0
Obesity
Public Health 306488 306488 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 300886 0
Prevention
Intervention code [2] 300887 0
Behaviour
Intervention code [3] 300888 0
Lifestyle
Comparator / control treatment
Stepped-wedged cluster randomised controlled trial, Five local government areas have been randomised to step 1, five local government areas have been randomised to step 2.
Control group
Dose comparison

Outcomes
Primary outcome [1] 307714 0
The primary outcome measure will be change in BMIz score among the children in the intervention group, (2 years and 3.5 years of age, children in Grade 2, Grade 4, Grade 6, )
Timepoint [1] 307714 0
2 years and 4 years after intervention commencement.
The intervention is deemed to commence after the completion of the third Group Model Building (GMB) workshop is held within the communities. It is during this workshop that community stakeholders will identify and prioritise strategies to implement and commence intervention activity within the community. GMB 3 will be scheduled at a time suitable to the communities, For Step 1 communities this is likely to occur sometime between February and April 2019.
Data is collected via a stadiometer and digital scale and/or de-identified previously collected data obtained from the central repository Maternal and Child Health Service.
Primary outcome [2] 308216 0
The second primary outcome measure will be change in the overweight and obesity prevalence calculated using the WHO cut points of children in the intervention group, (2 years and 3.5 years of age, children in Grade 2, Grade 4, Grade 6, )
Timepoint [2] 308216 0
2 years and 4 years after intervention commencement.
The intervention is deemed to commence after the completion of the third Group Model Building (GMB) workshop is held within the communities. It is during this workshop that community stakeholders will identify and prioritise strategies to implement and commence intervention activity within the community. GMB 3 will be scheduled at a time suitable to the communities, For Step 1 communities this is likely to occur sometime between February and April 2019.
Data is collected via a stadiometer and digital scale and/or de-identified previously collected data obtained from the central repository Maternal and Child Health Service.
Primary outcome [3] 308217 0
The third primary outcome measure will be change in the overweight and obesity prevalence calculated using the IOTF cut points (Cole & Lobstein 2012) of children in the intervention group, (2 years and 3.5 years of age, children in Grade 2, Grade 4, Grade 6, )
Timepoint [3] 308217 0
2 years and 4 years after intervention commencement.
The intervention is deemed to commence after the completion of the third Group Model Building (GMB) workshop is held within the communities. It is during this workshop that community stakeholders will identify and prioritise strategies to implement and commence intervention activity within the community. GMB 3 will be scheduled at a time suitable to the communities, For Step 1 communities this is likely to occur sometime between February and April 2019.
Data is collected via a stadiometer and digital scale and/or de-identified previously collected data obtained from the central repository Maternal and Child Health Service.
Secondary outcome [1] 352626 0
Change in the proportion of participants meeting the national physical activity guidelines.

Modified questionnaire containing items from the Core Indicators and Measures of Youth
Health (Card, Mansket et al (2012) and SHAPES Wong, Leaderdale et al (2006) surveys. A sub-sample of participants will also wear accelerometers.

Timepoint [1] 352626 0
Baseline and 2 and 4 years after GMB 3
Secondary outcome [2] 352627 0
This is a composite measure

Change in levels of perceived psychosocial influences on physical activity participation.

Modified questionnaire containing items from the Core Indicators and Measures of Youth
Health (Card, Mansket et al (2012) and SHAPES Wong, Leaderdale et al (2006) surveys. A sub-sample of participants will also wear accelerometers.
Timepoint [2] 352627 0
Baseline and 2 and 4 years after GMB 3
Secondary outcome [3] 353995 0
Change in typical/usual serves of fruit consumed daily by students in Grades 4 and 6

Modified version of the simple dietary questionnaire
Parlette & Frensham (2013); Parletta & Cooper et al (2013)
Timepoint [3] 353995 0
Baseline and 2 and 4 years after GMB 3

Secondary outcome [4] 354193 0
Change in typical/usual serves of non-core (discretionary) foods consumed daily by students in Grades 4 and 6

Modified version of the simple dietary questionnaire
Parlette & Frensham (2013); Parletta & Cooper et al (2013)
Timepoint [4] 354193 0
2 years and 4 years after intervention commencement (GMB 3).
Secondary outcome [5] 354194 0
Change in typical/usual serves of sugar-sweetened beverages consumed daily by students in Grades 4 and 6

Modified version of the simple dietary questionnaire
Parlette & Frensham (2013); Parletta & Cooper et al (2013)
Timepoint [5] 354194 0
2 years and 4 years after intervention commencement (GMB 3).
Secondary outcome [6] 354195 0
Change in the proportion of participants meeting the Australian Dietary guidelines for fruit intakes

Modified version of the simple dietary questionnaire
Parlette & Frensham (2013); Parletta & Cooper et al (2013)
Timepoint [6] 354195 0
2 years and 4 years after intervention commencement (GMB 3).
Secondary outcome [7] 354213 0
Change in proportion meeting the sleep guidelines of 8-10 hrs/night in grade 4 and grade 6 children.

Modified sleep behaviour questionnaire containing items from the Adolescent
Sleep Health Survey (ASHS) (LeBourgeois, Giannotti et al (2005), the School Sleep Hygiene Survey (SSHS) and the Children’s Sleep Health Questionnaire (CSHQ),, the Pittsburgh Sleep Quality Index (PSQI) Shahid, Wilkinson et al (2012),
Timepoint [7] 354213 0
Baseline, 2 years and 4 years after intervention commencement (GMB 3).
Secondary outcome [8] 354252 0
Changes in the proportion of participants meeting the national screen-time recommendations.

Modified questionnaire containing items from the Core Indicators and Measures of Youth
Health (Card, Mansket et al (2012) and SHAPES Wong, Leaderdale et al (2006) surveys. A sub-sample of participants will also wear accelerometers.
Timepoint [8] 354252 0
Baseline, 2 years and 4 years after intervention commencement (GMB 3).
Secondary outcome [9] 354253 0
Effectiveness of collaborative governance structure

Evaluation of collective impact through structured likert scale online survey.

Adapted from: Preskill, H., Parkhurst, M. and Juster, J. S., Guide to Evaluating Collective Impact, http://collectiveimpactforum.org/, 2012.
Timepoint [9] 354253 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [10] 354255 0
Change in typical/usual serves of vegetable daily by grade 4 and grade 6 children

Modified version of the simple dietary questionnaire
Parlette & Frensham (2013); Parletta & Cooper et al (2013)
Timepoint [10] 354255 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [11] 354256 0
Change in the proportion of participants meeting the Australian Dietary guidelines for vegetable intakes

Modified version of the simple dietary questionnaire
Parlette & Frensham (2013); Parletta & Cooper et al (2013)
Timepoint [11] 354256 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [12] 354274 0
Changes in school physical environment

Measured by school environment assessment tool (Katzmarzyk, P. T., Barreira, T. V., , et al., The International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE): design and methods, BMC Public Health, 2013, 13, 900)
Timepoint [12] 354274 0
Baseline, 2 years and 4 years post GMB 3

Measured by school environment assessment tool (Katzmarzyk, P. T., Barreira, T. V., , et al., The International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE): design and methods, BMC Public Health, 2013, 13, 900)
Preschools, Primary Schools: Be Active Eat Well Environment Questionnaire
Secondary outcome [13] 354275 0
Changes in school economic environment

Measured by school environment assessment tool (Katzmarzyk, P. T., Barreira, T. V., , et al., The International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE): design and methods, BMC Public Health, 2013, 13, 900)
Preschools, Primary Schools: Be Active Eat Well Environment Questionnaire
Timepoint [13] 354275 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [14] 354276 0
Changes in school socio-cultural environment

Measured by school environment assessment tool (Katzmarzyk, P. T., Barreira, T. V., , et al., The International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE): design and methods, BMC Public Health, 2013, 13, 900)
Preschools, Primary Schools: Be Active Eat Well Environment Questionnaire
Timepoint [14] 354276 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [15] 354277 0
Changes in food and beverage availability in school environments

Measured by school environment assessment tool (Katzmarzyk, P. T., Barreira, T. V., , et al., The International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE): design and methods, BMC Public Health, 2013, 13, 900)
Preschools, Primary Schools: Be Active Eat Well Environment Questionnaire
Timepoint [15] 354277 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [16] 354278 0
Changes in the school policy environment

Measured by school environment assessment tool (Katzmarzyk, P. T., Barreira, T. V., , et al., The International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE): design and methods, BMC Public Health, 2013, 13, 900)
Preschools, Primary Schools: Be Active Eat Well Environment Questionnaire
Timepoint [16] 354278 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [17] 354297 0
Estimating the cost-effectiveness of the trial

Two methods of economic evaluation will be used to address this outcome.
Both cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will be conducted prospectively alongside the trial, measuring the costs and benefits of the intervention incrementally against current practice in comparator regions. The economic evaluations will be conducted from a local authorities perspective at the community level. CEA will measure costs per reduction in obesity prevalence (study primary outcome) and cost per BMI unit saved. CUA will measure the cost per quality adjusted life year (QALY, based on the CHU-9D) gained, allowing for comparison of the cost-effectiveness results with other interventions using the QALY metric. Costs and benefits will be modelled over the lifetime using a cohort simulation Markov model, with extensive sensitivity analyses to gauge the impact on overall results of variations in key modelling parameters. The dollar value of community resources harnessed for $1 invested will be collected via governance stakeholder records and reports. Methods for the economic evaluation will be based on: Sweeney R, Moodie M, Nguyen P, et al Protocol for an economic evaluation of WHO STOPS childhood obesity stepped-wedge cluster randomised controlled trial. BMJ Open 2018;8:e020551. doi: 10.1136/bmjopen-2017-020551
Timepoint [17] 354297 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [18] 354299 0
Paediatric Quality of Life Scores (Varni 1998)

Change in psychosocial health summary score
Change in physical health summary score

This is a composite score
Timepoint [18] 354299 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [19] 354300 0
The diffusion of understanding of the issue of obesity through community networks.

This outcome is assessed via likert scale questions included in an online survey distributed to all signed partners of the NHMRC grant, all levels of governance and community stakeholders engaged with the group model building and implementation of RESPOND. The survey was validated in the study by Korn et al 2018.

Korn, A. R., Hennessy, E., Hammond, R. A., et al., Development and testing of a novel survey to assess Stakeholder-driven Community Diffusion of childhood obesity prevention efforts, BMC public health, 2018, 18, 681.
Timepoint [19] 354300 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [20] 354301 0
Changes in the level of resources allocated to addressing obesity through community networks.

Two questions specifically related to resources have been added to the online survey, these are:
Within our organisation we have paid staff who can be involved in the RESPOND project.
Our community has volunteers who can be involved in the RESPOND project.

Both questions are answered on a five-point likert scale from strongly disagree to strongly agree.


Timepoint [20] 354301 0
Baseline, 2 years and 4 years post GMB 3
Secondary outcome [21] 354302 0
The diffusion of action surrounding obesity through community networks over time.

This outcome is assessed as part of the online survey with specific questions that relate to social network analysis. Composite network characteristics at each time point will be derived from the survey data.
Questions are adapted from the Korn et al (2018) study and include:
1. Please provide the names of people with whom you discuss issues related to early childhood obesity in your area. You can mention up to 20 names and please enter the name of each person in its own entry box. The order of the names is not important. If you cannot remember a person’s full name, try to include as much descriptive information as you can.

2. To the best of your knowledge, please select each person’s group affiliation from the drop down list. If applicable, try to also enter each person’s organization or department and title in the spaces provided. It is okay to leave their organization/department blank if you think that their group affiliation is self-explanatory. It is also okay to leave category(s) blank if you are not sure.

Person Group affiliation Organization/department Title
[NAME 1] [DROP DOWN LIST]
[NAME 2] [DROP DOWN LIST]
[NAME 3] [DROP DOWN LIST]
The following questions ask about your relationships with the people you listed in the previous section.

3. How frequently do you typically interact with each person (in person, by mail, telephone, or Internet) about early childhood obesity in [name of area]?

Person Daily Weekly Monthly Quarterly Yearly
[NAME 1]
[NAME 2]
[NAME 3]

4. How close is your relationship with each person on a scale of 1 to 5, where 1 means not close and 5 means very close?

Person 1 (not close) 2 (a little close) 3 (neutral) 4 (close) 5 (very close)
[NAME 1]
[NAME 2]
[NAME 3]

5. How influential is each person in shaping your understanding of issues related to early childhood obesity in [name of area][?

Person 1 (not influential) 2 (a little influential) 3 (neutral) 4 (influential) 5 (very influential)
[NAME 1]
[NAME 2]
[NAME 3]
…
Korn, A. R., Hennessy, E., Hammond, R. A., et al., Development and testing of a novel survey to assess Stakeholder-driven Community Diffusion of childhood obesity prevention efforts, BMC public health, 2018, 18, 681.
Timepoint [21] 354302 0
Baseline, 2 years and 4 years post GMB 3

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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)
No allocation concealment. Allocation at the level of whole communities to intervention or control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation at the level of whole communities (local government areas) conducted by a statistician with no knowledge of the communities.
The ten LGAs will be ranked in order of population size and divided in five pairs.
One community from each pair will be randomly allocated to receive the intervention at Step one using a random list generated by CI Orellana (study statistician) who will not be involved with any aspect of the enrolment process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped-wedge (waitlist) design. Communities randomised to step 1 commence intervention in first year of trial, communities randomised to step 2 commence intervention 2 years later.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis will include analysis of BMIz scores, overweight and obesity prevalence and trend analysis.
Child behaviours and quality of life
Social Network analysis
Cost-effectiveness analysis
Cost-utility analysis
Descriptive statistics

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/01/2019
Actual
27/03/2019
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
10000
Accrual to date
3750
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 24721 0
3717 - Murrindindi
Recruitment postcode(s) [2] 24722 0
3722 - Mansfield
Recruitment postcode(s) [3] 24724 0
3676 - Wangaratta
Recruitment postcode(s) [4] 24725 0
3688 - Indigo Valley
Recruitment postcode(s) [5] 24728 0
3707 - Towong
Recruitment postcode(s) [6] 24781 0
3666 - Euroa
Recruitment postcode(s) [7] 24782 0
3608 - Goulburn Weir
Recruitment postcode(s) [8] 24783 0
3664 - Avenel
Recruitment postcode(s) [9] 24784 0
3669 - Creek Junction
Recruitment postcode(s) [10] 24785 0
3631 - Cosgrove
Recruitment postcode(s) [11] 24786 0
3523 - Heathcote
Recruitment postcode(s) [12] 24787 0
3714 - Alexandra
Recruitment postcode(s) [13] 24788 0
3658 - Hazeldene
Recruitment postcode(s) [14] 24789 0
3711 - Buxton
Recruitment postcode(s) [15] 24790 0
3777 - Badger Creek
Recruitment postcode(s) [16] 24791 0
3660 - Hilldene
Recruitment postcode(s) [17] 24792 0
3720 - Bonnie Doon
Recruitment postcode(s) [18] 24793 0
3723 - Gaffneys Creek
Recruitment postcode(s) [19] 24794 0
3673 - Benalla
Recruitment postcode(s) [20] 24795 0
3672 - Benalla West
Recruitment postcode(s) [21] 24796 0
3675 - Glenrowan
Recruitment postcode(s) [22] 24797 0
3725 - Boxwood
Recruitment postcode(s) [23] 24798 0
3726 - Bungeet
Recruitment postcode(s) [24] 24799 0
3723 - Archerton
Recruitment postcode(s) [25] 24800 0
3669 - Violet Town
Recruitment postcode(s) [26] 24811 0
3691 - Wodonga Forward
Recruitment postcode(s) [27] 24812 0
3690 - West Wodonga
Recruitment postcode(s) [28] 24813 0
3737 - Myrtleford
Recruitment postcode(s) [29] 24814 0
3741 - Bright
Recruitment postcode(s) [30] 24815 0
3699 - Mount Beauty
Recruitment postcode(s) [31] 24817 0
3697 - Tawonga
Recruitment postcode(s) [32] 24818 0
3698 - Tawonga South
Recruitment postcode(s) [33] 24819 0
3738 - Ovens
Recruitment postcode(s) [34] 24820 0
3739 - Eurobin
Recruitment postcode(s) [35] 24821 0
3740 - Mount Buffalo
Recruitment postcode(s) [36] 24822 0
3898 - Omeo
Recruitment postcode(s) [37] 24823 0
3690 - Wodonga
Recruitment postcode(s) [38] 24824 0
3691 - Allans Flat
Recruitment postcode(s) [39] 24825 0
3713 - Eildon
Recruitment postcode(s) [40] 24826 0
3715 - Merton
Recruitment postcode(s) [41] 24827 0
3722 - Barwite
Recruitment postcode(s) [42] 24828 0
3723 - Jamieson
Recruitment postcode(s) [43] 24829 0
3714 - Acheron
Recruitment postcode(s) [44] 24830 0
3670 - Tarnook
Recruitment postcode(s) [45] 24831 0
3677 - Wangaratta
Recruitment postcode(s) [46] 24832 0
3678 - Bobinawarrah
Recruitment postcode(s) [47] 24833 0
3682 - Lilliput
Recruitment postcode(s) [48] 24834 0
3685 - Rutherglen
Recruitment postcode(s) [49] 24835 0
3691 - Bandiana
Recruitment postcode(s) [50] 24836 0
3695 - Charleroi
Recruitment postcode(s) [51] 24837 0
3700 - Tallangatta
Recruitment postcode(s) [52] 24838 0
3701 - Mitta Mitta
Recruitment postcode(s) [53] 24839 0
3704 - Koetong
Recruitment postcode(s) [54] 24840 0
3705 - Cudgewa
Recruitment postcode(s) [55] 24841 0
3707 - Corryong
Recruitment postcode(s) [56] 24842 0
3708 - Tintaldra
Recruitment postcode(s) [57] 24843 0
3709 - Burrowye
Recruitment postcode(s) [58] 24844 0
3712 - Rubicon
Recruitment postcode(s) [59] 24845 0
3713 - Lake Eildon
Recruitment postcode(s) [60] 24846 0
3714 - Cathkin
Recruitment postcode(s) [61] 24847 0
3715 - Ancona
Recruitment postcode(s) [62] 24848 0
3717 - Flowerdale
Recruitment postcode(s) [63] 24849 0
3718 - Molesworth
Recruitment postcode(s) [64] 24850 0
3719 - Gobur
Recruitment postcode(s) [65] 24851 0
3723 - Barjarg
Recruitment postcode(s) [66] 24852 0
3733 - Whitfield
Recruitment postcode(s) [67] 24853 0
3735 - Bowmans Forest
Recruitment postcode(s) [68] 24854 0
3746 - Eldorado
Recruitment postcode(s) [69] 24856 0
3747 - Beechworth
Recruitment postcode(s) [70] 24857 0
3753 - Beveridge
Recruitment postcode(s) [71] 24858 0
3756 - Chintin
Recruitment postcode(s) [72] 24859 0
3757 - Eden Park
Recruitment postcode(s) [73] 24860 0
3758 - Heathcote Junction
Recruitment postcode(s) [74] 24862 0
3762 - Bylands
Recruitment postcode(s) [75] 24863 0
3763 - Kinglake
Recruitment postcode(s) [76] 24864 0
3764 - Forbes
Recruitment postcode(s) [77] 24865 0
3777 - Healesville
Recruitment postcode(s) [78] 24866 0
3778 - Fernshaw
Recruitment postcode(s) [79] 24867 0
3779 - Cambarville

Funding & Sponsors
Funding source category [1] 299205 0
Government body
Name [1] 299205 0
NHMRC
Country [1] 299205 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gheringhap Street
Geelong 3220
Victoria
Australia
Country
Australia
Secondary sponsor category [1] 300432 0
None
Name [1] 300432 0
Address [1] 300432 0
Country [1] 300432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300129 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 300129 0
Ethics committee country [1] 300129 0
Australia
Date submitted for ethics approval [1] 300129 0
15/11/2018
Approval date [1] 300129 0
15/01/2019
Ethics approval number [1] 300129 0
DUHREC 2018-381

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

Contacts
Principal investigator
Name 82658 0
Prof Steven Allender
Address 82658 0
Global Obesity Centre (GLOBE)
Deakin University
1 Gheringhap St
Geelong 3220 Victoria
Australia
Country 82658 0
Australia
Phone 82658 0
+61 03 5227 8305
Fax 82658 0
Email 82658 0
steven.allender@deakin.edu.au
Contact person for public queries
Name 82659 0
Joshua Hayward
Address 82659 0
Global Obesity Centre (GLOBE)
Deakin University
1 Gheringhap St
Geelong 3220
Victoria
Australia
Country 82659 0
Australia
Phone 82659 0
+61 03 5247 9694
Fax 82659 0
Email 82659 0
joshua.hayward@deakin.edu.au
Contact person for scientific queries
Name 82660 0
Joshua Hayward
Address 82660 0
Global Obesity Centre (GLOBE)
Deakin University
1 Gheringhap St
Geelong 3220
Victoria
Australia
Country 82660 0
Australia
Phone 82660 0
+61 03 5247 9694
Fax 82660 0
Email 82660 0
joshua.hayward@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be shared due to privacy and confidentiality as per ethics applications.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3889Ethical approval  melanie.nichols@deakin.edu.au
3890Study protocol  melanie.nichols@deakin.edu.au


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3889OtherAllender, S., Gaskin, C. J., Becker, D., Jackson, M., Orellana, L., Hayward, J., Bell, C., Nichols, M., Brown, V., Hillenaar, M., Moodie, M., Peeters, A., Brown, A. D., Whelan, J., Swinburn, B., & Strugnell, C. (2024). Three-year behavioural, health-related quality of life, and body mass index outcomes from the RESPOND randomized trial. Public Health, 237, 344-353.https://www.sciencedirect.com/science/article/pii/S0033350624004268?via%3DihubSteven.allender@deakin.edu.au 374900-(Uploaded-19-12-2024-11-47-34)-Allender et al 2024 - Outcomes paper.pdf
3890Study protocolWhelan J, Hayward J, Nichols M, Brown AD, Orellana L, Brow V, Becker D, Bell C, Swinburn B, Peeters A, Moodie M, Geddes SA, Chadwick C, Allender S, Strugnell C. Reflexive Evidence and Systems interventions to Prevention Obesity and Non-communicable Disease (RESPOND): protocol and baseline outcomes for a stepped-wedge cluster-randomised prevention trial. BMJ Open 2022; 12:e057187. doi:10.1136/bmjopen-2021-057187 knowledge and engagement in the stepped wedge cluster randomised trial for childhood obesity prevention in Australia: (Reflexive Evidence and Systems interventions to Prevent Obesity and Noncommunicable Disease (RESPOND))https://bmjopen.bmj.com/content/12/9/e057187Steven.allender@deakin.edu.au 374900-(Uploaded-19-12-2024-11-41-29)-Whelan et al 2020 KE Protocol.pdf
24416OtherStrugnell, C., Jackson, M., Hayward, J., Becker, D., Hillenaar, M., Bell, C., Allender, S. (2023). RESPOND Regional Childhood Health Behaviours and Anthropometry Report (2019-2022): Ovens Murray & Goulburn Valley Regional Reporthttps://iht.deakin.edu.au/wp-content/uploads/sites/153/2022/05/RESPOND-Regional-Report-2019.pdfSteven.allender@deakin.edu.au 374900-(Uploaded-19-12-2024-11-42-50)-RESPOND Regional Report 2019-2022 final.pdf

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
5292Study results articleYeshttps://doi.org/10.1016/j.puhe.2024.10.015 https://doi.org/10.1016/j.puhe.2024.10.015 Allender et al 2024 - Outcomes paper.pdf
5293Study results articleYeshttps://doi.org/doi: 10.1371/journal.pone.0302047 https://pubmed.ncbi.nlm.nih.gov/38696541/ Yoong et al 2024 - Action Respond.pdf
5294Study results articleYeshttps://doi.org/DOI: 10.1089/chi.2023.0054 https://pubmed.ncbi.nlm.nih.gov/37972074/ bell-et-al-2024-potential-mediating-roles-of-children-s-health-related-quality-of-life-and-weight-related-behaviors-in.pdf
5295Study results articleYeshttps://doi.org/10.1111/ajr.12996 Vargas, C, Hillenaar, M, Strugnell, C, Allender, S... [More Details] Australian J Rural Health - 2023 - Vargas - Lived experience of participants who engaged in the co-creation of initiatives.pdf
5296Study results articleYeshttps://doi.org/DOI: 10.1017/S1368980023000198 Jacobs J, Strugnell C, Becker D, Whelan J, Hayward... [More Details] Jacobs et al 2022.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for the measurement of changes in knowledge and engagement in the stepped wedge cluster randomised trial for childhood obesity prevention in Australia: (Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND)).2020https://dx.doi.org/10.1186/s13063-020-04692-6
EmbaseA Theory of Change for Community-Based Systems Interventions to Prevent Obesity.2022https://dx.doi.org/10.1016/j.amepre.2021.10.006
EmbaseReflexive Evidence and Systems interventions to Prevention Obesity and Non-communicable Disease (RESPOND): Protocol and baseline outcomes for a stepped-wedge cluster-randomised prevention trial.2022https://dx.doi.org/10.1136/bmjopen-2021-057187
N.B. These documents automatically identified may not have been verified by the study sponsor.