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临床试验/NCT07451535
NCT07451535进行中(未招募)不适用

Effectiveness of an Intervention to Reduce Sedentary Behavior During School Recess Among Adolescents: A Cluster Randomized Controlled Trial

South China Normal University12 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年10月8日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,000
试验地点
12
主要终点
Interruption of sedentary behaviour during school breaks

研究概览

简要总结

This cluster randomized controlled trial evaluated the effectiveness of an 8-week, school-based behavioural intervention grounded in the Multi-Process Action Control (M-PAC) framework in promoting interruption of sedentary behaviour during school breaks among adolescents. Twelve primary and secondary schools in China, were recruited and randomly allocated (at the school level) to either an intervention group or a control group to minimise contamination and support pragmatic delivery within the school setting. Schools assigned to the intervention group implemented a multi-component programme comprising educational materials, teacher-delivered guidance, peer reminders, and health lectures, whereas control schools continued their usual routines without receiving intervention materials. The primary outcome was interruption of sedentary behaviour during school breaks assessed using self-reported measures. Secondary outcomes included physical activity levels, emotional and behavioural problems, executive function, and psychological factors related to behaviour regulation, such as motivation, planning, and habit. Findings from this trial are intended to inform the development and implementation of feasible, theory-informed school strategies to reduce sedentary behaviour during school breaks.

详细描述

This study was a cluster randomized controlled trial designed to evaluate the effectiveness of a school-based intervention grounded in the Multi-Process Action Control (M-PAC) framework to promote interruption of sedentary behaviour during school breaks among adolescents. A cluster randomization design was adopted, with schools as the unit of randomization, to minimise contamination between participants and to enhance the feasibility of intervention delivery within the school setting.

Twelve primary and secondary schools in China were recruited using convenience sampling and randomly allocated to either an intervention group or a control group. Schools were recruited through existing school partnerships and administrative feasibility considerations. The majority of participating schools were located in Guangdong Province (n=9), reflecting the location of the coordinating research team and the primary recruitment network. To enhance the diversity of school contexts and improve the external validity of findings, additional schools were recruited from Hainan (n=1) and Shanxi (n=2) using the same eligibility criteria and standardized implementation procedures across sites. The intervention was implemented over an 8-week period. Schools assigned to the intervention group received a multi-component programme informed by the M-PAC framework, designed to target key behaviour regulation processes relevant to sedentary behaviour interruption, including reflective, regulatory, and reflexive mechanisms. Intervention components included weekly educational leaflets, guidance delivered by physical education teachers, peer reminders during school breaks, and health lectures. Schools assigned to the control group continued their usual school routines and did not receive intervention materials during the study period.

The primary outcome was interruption of sedentary behaviour during school breaks, assessed using self-reported measures. Secondary outcomes encompassed physical activity levels, emotional and behavioural problems, executive function, and social-cognitive variables derived from the M-PAC framework (e.g., attitudes, intention, and habit). In addition, process evaluation indicators (e.g., intervention fidelity) and relevant covariates (e.g., demographic characteristics, academic stress, and the school physical activity environment) were assessed to support interpretation of intervention effects.The study involved a non-clinical population and did not include biomedical or medical health outcomes. The study protocol was approved by the institutional ethics committee, and written informed consent was obtained from all participants prior to participation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of the school-level implementation of the intervention, it was not possible to blind school administrators, teachers, and students to group allocation. However, outcome assessors were kept blinded to the group assignment. Throughout the data collection process, participants were instructed not to disclose their group allocation.

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Students aged 10-17 years
  • Enrolled in participating primary or secondary schools
  • Able to participate in regular school physical activities and daily routines
  • Able to understand and complete study questionnaires
  • Willing to comply with study procedures
  • Written informed consent obtained from parents or legal guardians

排除标准

  • Diagnosed medical conditions that contraindicate participation in physical activity
  • Physical disabilities, injuries, or health conditions that limit normal participation in school-based activities
  • Participation in other structured physical activity or sedentary behavior intervention programs during the study period
  • Cognitive or language difficulties that preclude understanding of study procedures or completion of questionnaires
  • Inability or unwillingness to comply with study procedures

研究组 & 干预措施

Usual Pratice Control

No Intervention

Schools allocated to the control group continued their usual school routines during the 8-week study period and did not receive any intervention materials or behaviour-change components related to sedentary behaviour interruption. No additional guidance, reminders, or educational materials were provided. Data collection procedures were conducted in the same manner as in the intervention group.

Sedentary Interruption Intervention

Experimental

The intervention was grounded in the Multi-Process Action Control (M-PAC) framework and targeted behaviour regulation processes relevant to sedentary interruption. Intervention components included: 1) Weekly educational leaflets providing information on the health risks of prolonged sedentary behaviour and practical strategies to interrupt sitting during school breaks. 2) Guidance delivered by physical education teachers, reinforcing key messages and encouraging active break behaviours. 3) Peer reminders were delivered during school breaks by class-appointed student PE representatives-one student per class nominated by the PE teacher (typically a high-performing student in PE) to support the organization and promotion of physical activity. 4) Health lectures delivered by members of the research team to enhance awareness and motivation related to sedentary behaviour interruption.

干预措施: Sedentary Interruption Intervention (Behavioral)

结局指标

主要结局

Interruption of sedentary behaviour during school breaks

时间窗: Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).

Interruption of sedentary behaviour during routine school breaks (between lessons; excluding longer "big recess" periods) was assessed over the past 7 school days using a single-item self-report measure adapted from the Workplace Sitting Breaks Questionnaire (SITBRQ) for the school context. Students reported the average time spent standing or walking to interrupt sitting during a typical routine class break (0 min, ≤5 min, \>5-\<10 min, ≥10 min); higher categories indicate greater break-time sedentary interruption. The item wording was modified to reflect school break periods while retaining the original construct of sedentary break behaviour.

次要结局

  • Self-reported physical activity(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)
  • Identity toward interrupting sedentary behaviour during school breaks(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)
  • Emotional and behavioural problems(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)
  • Executive function(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)
  • Affective attitude toward interrupting sedentary behaviour during school breaks(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention))
  • Instrumental attitude toward interrupting sedentary behaviour during school breaks(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention))
  • Perceived capability toward interrupting sedentary behaviour during school breaks(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)
  • Intention toward interrupting sedentary behaviour during school breaks(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)
  • Perceived opportunity toward interrupting sedentary behaviour during school breaks(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)
  • Planning toward interrupting sedentary behaviour during school breaks(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)
  • Self-monitoring toward interrupting sedentary behaviour during school breaks(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)
  • Habit strength(Baseline, Week 8 (Post-intervention), Week 16 (Follow-up, 8 weeks post-intervention), and Week 24 (Follow-up, 16 weeks post-intervention).)

研究者

发起方
South China Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ru ZHANG

Associate Professor ; Principal Investigator

South China Normal University

研究点 (12)

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