NCT07452302

Brief Summary

This randomized controlled trial evaluates whether a 12-week school-based physical education program that combines cooperative sports games and ball sports can improve mental health and physical fitness in rural left-behind children. Left-behind children are those who remain in rural areas while one or both parents migrate for work. These children may experience social and emotional challenges in addition to physical health concerns. Forty sixth-grade boarding students who met the criteria for left-behind children were randomly assigned to either a mixed training group or a usual physical education control group. The intervention was delivered during regular school physical education classes three times per week, 90 minutes per session, for 12 weeks. Each session included cooperative physical games designed to promote peer interaction, followed by structured soccer or basketball training activities. Mental health was assessed using the Mental Health Test (MHT), and physical fitness was evaluated using standardized school-based tests including lung function, running performance, flexibility, and coordination. Outcomes were measured before and after the intervention. The study aims to determine whether optimizing the structure of routine school physical education can provide a feasible and scalable strategy to support both psychological well-being and physical development in vulnerable child populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 1, 2026

Last Update Submit

March 1, 2026

Conditions

Keywords

left-behind childrenschool-based interventionphysical educationsports gamesball sportsrandomized controlled trialchild mental healthaerobic fitnesssocial interactioncooperative play

Outcome Measures

Primary Outcomes (1)

  • Mental Health Test (MHT) Total Score

    The Mental Health Test (MHT) is a standardized self-report instrument used to assess psychological status in school-aged children. The total score reflects overall psychological difficulty, with higher scores indicating greater levels of psychological problems.

    Baseline and Week 12 (Immediately Post-Intervention)

Secondary Outcomes (9)

  • Interpersonal Anxiety (MHT Subscale Score)

    Baseline and Week 12 (Immediately Post-Intervention)

  • Self-Blame Tendency (MHT Subscale Score)

    Baseline and Week 12 (Immediately Post-Intervention)

  • Vital Capacity (mL)

    Baseline and Week 12 (Immediately Post-Intervention)

  • 50-Meter Dash Time (seconds)

    Baseline and Week 12 (Immediately Post-Intervention)

  • 8×50-Meter Shuttle Run Time (seconds)

    Baseline and Week 12 (Immediately Post-Intervention)

  • +4 more secondary outcomes

Study Arms (2)

Mixed Training Group (MTG)

EXPERIMENTAL

Participants in this arm received a structured 12-week school-based physical education intervention delivered three times per week (90 minutes per session). Each session included a 20-25 minute cooperative sports game segment followed by 55-60 minutes of structured soccer or basketball training with progressive intensity and small-sided games. The intervention was implemented within the regular physical education curriculum.

Behavioral: Mixed Physical Education Program

Usual Physical Education Control Group (CONG)

ACTIVE COMPARATOR

Participants in this arm followed the standard school physical education curriculum for 12 weeks. The curriculum primarily included calisthenics and general physical fitness training without structured cooperative sports games or systematic ball sports training.

Behavioral: Usual Physical Education

Interventions

Participants received a structured 12-week school-based physical education program delivered three times per week (90 minutes per session). Each session included a cooperative sports game component (20-25 minutes) designed to promote peer interaction and social engagement, followed by structured soccer or basketball training (55-60 minutes) with progressive skill development and small-sided games. Exercise intensity was staged to achieve approximately 60-85% of age-predicted maximal heart rate. The intervention was implemented within the regular school physical education curriculum.

Mixed Training Group (MTG)

Participants followed the standard school physical education curriculum for 12 weeks, consisting primarily of calisthenics and general physical fitness activities. The curriculum did not include structured cooperative sports games or systematic soccer or basketball training as provided in the experimental intervention.

Usual Physical Education Control Group (CONG)

Eligibility Criteria

Age12 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 12 to 13 years
  • Enrolled in the sixth grade of the participating rural primary school
  • Classified as left-behind children, defined as separation from one or both parents for more than six months due to parental migration for work
  • Boarding-school students during the study period
  • Provided written informed consent from legal guardians and written assent from the child

You may not qualify if:

  • Children from single-parent families or orphans
  • Presence of physical, neurological, or medical conditions that would limit participation in regular physical activity
  • Participation in any structured extracurricular physical training program during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rural Primary School in J County

Wuhu, Anhui, 241000, China

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors responsible for physical fitness testing were blinded to group allocation. Participants and the physical education teacher delivering the intervention were not blinded due to the nature of the study design.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to either a mixed training group (MTG) or a usual physical education control group (CONG). Both groups received physical education during the same 12-week period. The MTG received a structured mixed intervention combining cooperative sports games and ball sports, while the CONG followed the standard school curriculum. No crossover occurred between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2026

First Posted

March 5, 2026

Study Start

September 1, 2025

Primary Completion

January 9, 2026

Study Completion

January 9, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations