IMplementation and Evaluation of the School-based Family Support PRogramme A Healthy School Start to Promote Child Health and Prevent OVErweight and Obesity (IMPROVE) - Study Protocol for a Cluster-randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,634
- 试验地点
- 3
- 主要终点
- Change in fidelity (A) assessed by questionnaire to parents and school staff
研究概览
简要总结
IMPROVE is an implementation study aiming to explore the effects of two bundled implementation strategies on the intervention fidelity of the Healthy School Start program (primary outcome) while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). Thirty schools in two municipalities will receive the HSS program reaching about 1400 families per school year, for two years.
详细描述
IMPROVE aims to conduct a hybrid type 3 evaluation design to test the effects of bundled implementation strategies on the intervention fidelity (primary outcome) of the Healthy School Start (HSS) program while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). The HSS is a 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parent risk of developing type 2 diabetes.
IMPROVE is a cluster-randomized controlled trial with two arms to evaluate and compare the effects of two different bundles of implementation strategies on intervention fidelity expressed as adherence and responsiveness at 12 and 24 months. Thirty schools in two municipalities will participate in the study reaching about 1400 families per school year. In stakeholder workshops, key implementation determinants were identified according to the domains of the Consolidated Framework for Implementation Research. Through a consensus process with stakeholders, two bundles of implementation strategies were tailored to address context-specific determinants. Schools randomly assigned to group 1 will receive bundle 1 (Basic) and group 2 will receive bundle 1+2 (Enhanced), consisting mainly of external facilitation, fidelity monitoring and feedback strategies. Secondary outcomes will include acceptability, appropriateness, feasibility, organisational readiness as perceived by school staff, child weight status and diet, and parents' risk of type 2 diabetes. Linear and ordinal regression analysis will be used to test the effect on the primary and secondary outcomes, taking clustering into consideration where needed. Process evaluation will be conducted through key stakeholder interviews to investigate experiences of the program and stakeholder perceptions on sustainability.
This systematic approach to investigating the effects of two different bundles of implementation strategies tailored to context-specific determinants on the fidelity of the HSS intervention will provide new insight into feasible implementation strategies and the external supports needed for a school-based health program like the HSS to be effective and sustainable. Results will help inform how to bridge the gap between the research on school-based health programs and routine practice in schools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Researchers and school personnel will not be blinded to group allocation, but parents and children will be blinded.
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children and their parents at the included schools. All involved personnel at the included schools
排除标准
- 未提供
研究组 & 干预措施
Basic
All schools will receive the HSS program. Schools randomly assigned to group 1 will receive implementation strategy bundle 1 (Basic).
干预措施: Healthy School Start (Behavioral)
Enhanced
All schools will receive the HSS program. Schools randomly assigned to group 2 will receive implementation strategy bundle 1+2 (Enhanced).
干预措施: Healthy School Start (Behavioral)
结局指标
主要结局
Change in fidelity (A) assessed by questionnaire to parents and school staff
时间窗: Measured at 12 and 24 months
Adherence to the four HSS components by indicators developed for this study. Information will be gathered through attendance logs and questionnaires to school staff and parents.
Change in fidelity (R) assessed by questionnaire to parents
时间窗: Measured at 12 and 24 months
Responsiveness to the four HSS components by indicators developed for this study. Information will be gathered through questionnaires to parents.
次要结局
- Change in feasibility of the HSS program measured by questionnaire(Measured at baseline, 12, 24, and 36 months)
- Change in Organisational readiness of school principals assessed by questionnaire(Measured at baseline, 12, 24, and 36 months)
- Change in Organisational readiness by school staff assessed by questionnaire(Measured at baseline, 12, 24, and 36 months)
- Change in child diet assessed by parent questionnaire(Baseline, 12 months, and 24 months)
- Change in appropriateness of the HSS program measured by questionnaire(Measured at baseline, 12, 24, and 36 months)
- Change in acceptability of the HSS program assessed by questionnaire(Measured at baseline, 12, 24, and 36 months)
- Fidelity to implementation strategies assessed by checklist(May each year)
- Change in child weight status assessed through measurement of height (m) and weight (kg)(Measured at baseline and after 24 months)
- Change in child BMI z-score assessed through measurement of height (m) and weight (kg)(Measured at baseline and after 24 months)
- Change in parents' risk of type 2 diabetes assessed by FINDRISC questionnaire(Measured at Baseline, 12 months, and 24 months)
- Change in parental feeding practices assessed by parent questionnaire(Baseline, 12 months, and 24 months)
研究者
Liselotte Schäfer Elinder
professor
Karolinska Institutet