- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07452302
Mixed PE Program Using Sports Games and Ball Sports in Left-Behind Children (MIXPE-LBC)
A 12-Week School-Based Mixed Physical Education Intervention Combining Cooperative Sports Games and Ball Sports to Improve Mental Health and Physical Fitness in Rural Left-Behind Children
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a single-center, parallel-group randomized controlled trial conducted in a rural primary boarding school in China. The objective was to evaluate the effects of a structured 12-week mixed physical education intervention integrating cooperative sports games and ball sports on mental health and physical fitness in left-behind children.
Eligible participants were sixth-grade students who had been separated from one or both parents for more than six months and met the study's screening criteria for left-behind children. After baseline assessment, participants were randomly allocated in a 1:1 ratio to either the mixed training group (MTG) or the control group (CONG) using block randomization (block size = 4) with allocation concealment via sequentially numbered opaque sealed envelopes. Outcome assessors were blinded to group assignment.
The intervention was delivered within the routine physical education curriculum (three sessions per week, 90 minutes per session, for 12 weeks). Each session included: (1) a 20-25 minute cooperative game segment emphasizing social interaction and group participation; (2) a 55-60 minute structured soccer or basketball training segment with progressive skill development and small-sided games; and (3) a brief cool-down period. Exercise intensity was staged using target heart rate zones corresponding to approximately 60-85% of age-predicted maximal heart rate.
The primary outcome measure was the total score of the Mental Health Test (MHT). Secondary outcomes included MHT subscales and standardized physical fitness indicators (vital capacity, 50-m dash, 8×50-m shuttle run, rope skipping, sit-ups, sit-and-reach, and body mass index). All outcomes were assessed at baseline and immediately post-intervention.
Data were analyzed using two-way repeated-measures analysis of variance to assess group, time, and interaction effects. The study was conducted in accordance with the Declaration of Helsinki and was approved by the institutional ethics committee.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Anhui
-
Wuhu, Anhui, China, 241000
- Rural Primary School in J County
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mixed Training Group (MTG)
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.
|
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.
|
|
Active Comparator: Usual Physical Education Control Group (CONG)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental Health Test (MHT) Total Score
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interpersonal Anxiety (MHT Subscale Score)
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
Interpersonal Anxiety is a subscale of the Mental Health Test (MHT) assessing social anxiety and interpersonal stress.
Higher scores indicate greater levels of interpersonal anxiety.
|
Baseline and Week 12 (Immediately Post-Intervention)
|
|
Self-Blame Tendency (MHT Subscale Score)
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
Self-Blame Tendency is a subscale of the Mental Health Test (MHT) evaluating self-directed negative attribution patterns.
Higher scores indicate greater self-blame.
|
Baseline and Week 12 (Immediately Post-Intervention)
|
|
Vital Capacity (mL)
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
Vital capacity measured in milliliters using standardized school-based pulmonary function testing procedures.
|
Baseline and Week 12 (Immediately Post-Intervention)
|
|
50-Meter Dash Time (seconds)
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
Time required to complete a 50-meter sprint, recorded in seconds.
|
Baseline and Week 12 (Immediately Post-Intervention)
|
|
8×50-Meter Shuttle Run Time (seconds)
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
Total time required to complete eight 50-meter shuttle runs, recorded in seconds.
|
Baseline and Week 12 (Immediately Post-Intervention)
|
|
Rope Skipping Performance (repetitions per minute)
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
Number of rope skipping repetitions completed within one minute.
|
Baseline and Week 12 (Immediately Post-Intervention)
|
|
Sit-Ups Performance (repetitions per minute)
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
Number of sit-ups completed within one minute.
|
Baseline and Week 12 (Immediately Post-Intervention)
|
|
Sit-and-Reach Distance (centimeters)
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
Maximum forward reach distance measured in centimeters using a standardized sit-and-reach test.
|
Baseline and Week 12 (Immediately Post-Intervention)
|
|
Body Mass Index (kg/m²)
Time Frame: Baseline and Week 12 (Immediately Post-Intervention)
|
Body mass index calculated from measured height and weight (kg/m²).
|
Baseline and Week 12 (Immediately Post-Intervention)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHNU-MIXPE-LBC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsNot yet recruitingMental Health | Mental Health Help-Seeking | Mental Health LiteracyUnited States
-
Neslihan LokCompletedAdolescent | Mental Health | Mental Health Care | Mental Health ConditionsTurkey
-
GCS-CCOMSINSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)Active, not recruitingRecovery | Organization of Health Service | Mental Health Services | Mental Health CareFrance
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Universidad Metropolitana de Ciencias de la EducacionNot yet recruitingMental Health | Physical Inactivity | Cardiovascular Health | Mental Health Care | Sedentary BehaviorsChile
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
Chinese University of Hong KongRecruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; The Hong Kong... and other collaboratorsRecruitingMental Well-being | Adolescent Health | Mental Health Help-Seeking | Mental Health Literacy | School Difficulties Associated With Mental Health ProblemsHong Kong
Clinical Trials on Mixed Physical Education Program
-
University of Southern DenmarkUniversity College LillebæltCompletedPhysical Activity | Risk Factor, Cardiovascular | Obesity, Childhood | Motor Activity | Sports InjuryDenmark
-
Inonu UniversityCompletedIntellectual Disability, Mild | Muscular StrengthTurkey (Türkiye)
-
Chonnam National University HospitalNot yet recruiting
-
Case Western Reserve UniversityNational Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States
-
Universidad de Santiago de ChileCompletedPhysical Activity | Health Promotion | Child Health | Sports | Physical Fitness | Sedentary BehaviorsChile
-
University of ValenciaGeneralitat ValencianaRecruiting
-
Saglik Bilimleri UniversitesiRecruitingAutism Spectrum Disorder | Telerehabilitation | Nutrition | Physiotherapy and RehabilitationTurkey
-
Mardin Artuklu UniversityRecruitingLabor; Poor, PrimaryTurkey (Türkiye)
-
Jinan University GuangzhouActive, not recruitingSedentary Behavior | Mental Well-being | Physical Inactivity | Adolescent Mental HealthChina
-
University of VigoCompletedMusculoskeletal PainPortugal