ACTRN12618001986268招募中未知
Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND): a cluster randomised controlled trial in Victorian communities
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 10,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit(—)
- 性别
- All
入选标准
- •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
- •5. Wodonga
- •6. Mitchell
- •7. Benalla
- •8. Wangaratta
- •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:
- •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.
排除标准
- •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.
研究者
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