NCT07451535

Brief Summary

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 27, 2026

Last Update Submit

February 27, 2026

Conditions

Keywords

Cluster randomized controlled trialsedentary interruptionschool breaksMulti-Process Action Control

Outcome Measures

Primary Outcomes (1)

  • Interruption of sedentary behaviour during school breaks

    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.

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

Secondary Outcomes (12)

  • 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).

  • 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)

  • +7 more secondary outcomes

Other Outcomes (1)

  • Process evaluation variables

    Week 8 (Post-intervention)

Study Arms (2)

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.

Behavioral: Sedentary Interruption Intervention

Interventions

A multi-component, school-based behavioural program implemented over 8 weeks to promote interruption of sedentary behaviour during school breaks. The program was informed by the Multi-Process Action Control framework and designed to support behaviour regulation related to break-time sedentary interruption. 1. Educational leaflets (weekly): brief printed materials distributed once per week, providing information on sedentary behaviour and practical strategies to interrupt sitting during school breaks. 2. Teacher guidance: physical education (PE) teachers provided brief guidance and reinforcement of key messages during routine school activities/classes, encouraging students to interrupt sedentary time during breaks. 3. Peer reminders during school breaks: reminders were delivered by class-appointed student PE representatives. 4. Health lectures: health lectures were delivered by members of the research team during the intervention period to support awareness and and motivation.

Sedentary Interruption Intervention

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Jingshi Liyun Experimental School

Foshan, Guangdong, 528300, China

Location

Dongping Primary School, Foshan

Foshan, Guangdong, 528315, China

Location

Zhixin Middle School (Pazhou Experimental School)

Guangzhou, Guangdong, 510006, China

Location

Experimental Secondary School of Guangdong University of Foreign Studies

Guangzhou, Guangdong, 510420, China

Location

Gaotangshi Primary School

Guangzhou, Guangdong, 510520, China

Location

Guangdong University of Education (Panyu Affiliated Junior Secondary School)

Guangzhou, Guangdong, 511436, China

Location

Overseas Chinese Town Primary School

Shenzhen, Guangdong, 518053, China

Location

Lin Weimin Memorial Primary School

Zhuhai, Guangdong, 519040, China

Location

Lihe Primary School

Zhuhai, Guangdong, 519085, China

Location

Haikou No.9 Middle School

Haikou, Hainan, 570102, China

Location

Pingyao Middle School - Junior High Division

Jinzhong, Shanxi, 031100, China

Location

Pingyao Middle School - Primary Division

Jinzhou, Shanxi, China

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ru ZHANG

    South China Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study used a cluster randomized, parallel-group design, with schools as the unit of randomization. Eligible schools were randomly allocated to either the intervention or control condition to minimize contamination between students within the same school. Outcomes were assessed at the individual (student) level following a standardized protocol.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor ; Principal Investigator

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 5, 2026

Study Start

October 8, 2025

Primary Completion

July 30, 2026

Study Completion

July 30, 2026

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations