Feasibility of an Intervention to Promote Physical Activity in Preschool Children: A Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Participant Recruitment
研究概览
简要总结
The aim of this study is to develop, implement, and evaluate a novel intervention to increase physical activity and reduce sedentary behaviour among pre-school children, with the ultimate goal of reducing obesity among this age group. This study will provide evidence-based recommendations for reducing the prevalence of obesity among preschool-aged children, and the suggestions will help improve the physical activity intervention programme in preschoolers.
详细描述
The pre-school-based I'm an Active Hero (IAAH) intervention with family involvement was developed in accordance with the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The development phase consists of locating and synthesising existing evidence (such as what is already known about existing interventions) and finding and developing theories (e.g., developing a theoretical understanding of the expected process of behaviour change). The IAAH-intervention components are theory- and evidence-based; they were developed based on a comprehensive identification and evaluation of current and past community, preschool, and family-based physical activity and lifestyle change interventions, as well as recommendations from a recent systematic review and review of reviews.
Additionally, the IAAH-intervention component was informed by conducting a systematic review to identify promising intervention components, including behaviour change techniques, that are associated with interventions that were able to increase PA in the preschool age group. In addition to conducting a qualitative study with teachers and patients/guardians, investigators will also consult them on the intervention's content and duration. Investigators would consider the suggestions and ideas from the preschool practitioners' and parent/guardian focus group meetings, which will establish the meaning of PA for the two distinct stakeholder groups, their influences on this, and considerations for a future intervention. The Template for Intervention Description and Replication (TIDieR) framework was also used to set up the intervention component.
The design of the intervention will employ systematic review and qualitative phases to inform the quantitative, feasibility phase, followed by a further qualitative phase (stakeholders will be involved in the further refinement of the intervention to add richness and depth). Findings from the systematic review and qualitative work will inform the development of the IAAH intervention.
Intervention: This will be a feasibility study of a two-arm cluster-randomised controlled trial (RCT) and will consist of an intervention group and a control group with two data collection time points (i.e., baseline and post-intervention) to test the feasibility and efficacy of a 10-week "I'm an Active Hero (IAAH)" programme intervention with the aim of improving physical activity and decreasing sedentary behaviour of preschool children aged between 3 and 5 years in Taif City, Saudi Arabia.
Process evaluation: This will be a qualitative study including interviews and/or questionnaires with stakeholders (pre-school principals, teachers, classroom assistants, and parents/guardians) to determine the acceptability of the intervention from the participants' perspectives.
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
- None
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children in the preschool years, ages 3 to 5, whose parents or guardians consent to their participation in the study
- •An ambulatory individual who does not require physical assistance
- •Children who able to follow verbal instructions
排除标准
- •Children older than 5 years old
- •Children for whom parental/caregiver consent is not provided
- •Children with a concurrent medical condition that affects their ability to physically walk a certain distance or with health issues that might influence their participation in the intervention
结局指标
主要结局
Participant Recruitment
时间窗: 10 weeks
The expected number of participants to be recruited in this study. (Outcome related to trial feasibility).
Participants Retention
时间窗: 10 weeks post baseline
The proportion of participants who will complete outcome assessments In either (intervention and control group).(Outcome related to trial feasibility).
Preschool Retention
时间窗: 10 weeks post baseline
The percentage of preschools which were retained throughout the study.(Outcome related to trial feasibility)
Baseline Week ActiGraph Accelerometers-GT3X Return Rate at the End of the Baseline Week
时间窗: 1 week
Number of children who will return their ActiGraph accelerometers-GT3X at the end of baseline week on the scheduled day (all children wore the accelerometers simultaneously)
Damaged or Lost ActiGraph Accelerometers-GT3X
时间窗: 11 weeks (1 week at baseline and 10 weeks after baseline
Number of ActiGraph accelerometers-GT3X that may loss or damage during this study
Intervention Fidelity
时间窗: 10 weeks
Intervention fidelity will be undertaken using the teacher's logbook of the number of sessions conducted per week and structure followed in relation to classroom guides) and observing the delivery of interventions, including two sessions of physical activity and sedentary behaviour will be observed at intervention pre-school at the midpoint through the intervention. At the end of the intervention, teachers and parents will be asked to take part in focus group and /or questionnaires.(Outcome related to trial feasibility).
Acceptability : Intervention Acceptance
时间窗: 1 week after the end of the intervention
Intervention acceptance will be assessed via a post-intervention acceptance questionnaire and/or qualitative data from a post-intervention focus group.(outcome related to trial acceptability).
Return of ActiGraph Accelerometers-GT3X on Time by Post-baseline Week Participants
时间窗: 10 weeks after baseline
The number of participants who will return their ActiGraph accelerometers-GT3X to the researcher on the designated day, at end of post-baseline week.
Preschool Facilities that Agreed to Participate
时间窗: 10 weeks
The proportion of preschools that agreed to take part in the study.(Outcome related to trial feasibility)
次要结局
- Change in Body Mass Index (BMI z-score) Measurement(Baseline and 10 weeks post-intervention)
- Change in Participants Sedentary Behaviour from Baseline to Post-intervention(Baseline and 10 weeks post-intervention)
- Change in Participants Physical Activity from Baseline to Post-intervention(Baseline and 10 weeks post-intervention)
研究者
NeilHeron
Principal Investigator, Neil Heron
Queen's University, Belfast