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

INTERVENTION: 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 capacit CONDITION: Diet and Nutrition ‐ Obesity Obesity; ; Obesity Public Health ‐ Health promotion/education SECONDARY OUTCOME: 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)[2 years and 4 years after intervention commencement (GMB 3).] 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), [Baseline, 2 years and 4 years after intervention commencement (GMB 3).] 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)[2 years and 4 years after intervention commencement (GMB 3).] 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) ; ; [Baseline, 2 years and 4 years post GMB 3] 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. PRIMARY OUTCOME: 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, )[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.; ] 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, )[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.; ] 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, ); [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.; ] ; ; [Baseline and 2 and 4 years after GMB 3 ] 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)[Baseline and 2 and 4 years after GMB 3 ; ; ] 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 ; ; ] Paediatric Quality of Life Scores (Varni 1998) ; ; Change in psychosocial health summary score ; Change in physical health summary score ; ; This is a composite score [Baseline, 2 years and 4 years post GMB 3] The diffusion of action surrounding obesity through community networks over time. ; ; Questions are adapted from the Korn et al (2018) study and include: ; ; ; Person Group affiliation Organization/department Title ; [NAME 1] [DROP DOWN LIST] ; [NAME 2] [DROP DOWN LIST] ; Parlette & Frensham (2013); Parletta & Cooper et al (2013)[2 years and 4 years after intervention commencement (GMB 3).] 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) ; [Baseline, 2 years and 4 years post GMB 3] 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[Baseline, 2 years and 4 years post GMB 3 ; ; ] 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[Baseline, 2 years and 4 years post GMB 3 ; ; ; ; ] 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) ; [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 ; ] 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 ; [Baseline, 2 years and 4 years post GMB 3 ; ; ; ] 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. ; ; ; [Baseline, 2 years and 4 years post GMB 3] 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. ; [Baseline, 2 years and 4 years after intervention commencement (GMB 3). ; ] Changes in the school policy environment ; ; Preschools, Primary Schools: Be Active Eat Well Environment Questionnaire[Baseline, 2 years and 4 years post GMB 3] Effectiveness of collaborative governance structure ; ; Evaluation of collective impact through structured likert scale online survey. ; ; ; Two methods of economic evaluation will be used to address this outcome. ; 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) ; Adapted from: Preskill, H., Parkhurst, M. and Juster, J. S., Guide to Evaluating Collective Impact, http://collectiveimpactforum.org/, 2012.[Baseline, 2 years and 4 years post GMB 3] Estimating the cost‐effectiveness of the trial ; 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[Baseline, 2 years and 4 years post GMB 3 ; 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. ; 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. ; [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. ; [Baseline, 2 years and 4 years post GMB 3] 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. ; ; ; ; [Baseline, 2 years and 4 years post GMB 3] 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. ; [Baseline and 2 and 4 years after GMB 3 ] 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 member