Mental HealthMIXPE-LBCNCT07452302
Mixed PE Program Using Sports Games and Ball Sports in Left-Behind Children
A study testing Mixed Physical Education Program and Usual Physical Education in people with Mental Health and Physical Fitness, run by Anhui Normal University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Physical Fitness, Left-Behind Children
- What is being tested?
- Mixed Physical Education Program and Usual Physical Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Mental Health, Physical Fitness, Left-Behind Children
- Being tested
- Mixed Physical Education Program, Usual Physical Education
- Keywords
- left-behind children, school-based intervention, physical education, sports games, ball sports, randomized controlled trial, child mental health, aerobic fitness, social interaction, cooperative play
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Physical Education ProgramBehavioural
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.
Usual Physical EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Physical Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12 (Immediately Post-Intervention)
Secondary outcomes (9)
Interpersonal Anxiety (MHT Subscale Score)
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.
Measured: Baseline and Week 12 (Immediately Post-Intervention)
Self-Blame Tendency (MHT Subscale Score)
Self-Blame Tendency is a subscale of the Mental Health Test (MHT) evaluating self-directed negative attribution patterns. Higher scores indicate greater self-blame.
Measured: Baseline and Week 12 (Immediately Post-Intervention)
Vital Capacity (mL)
Vital capacity measured in milliliters using standardized school-based pulmonary function testing procedures.
Measured: Baseline and Week 12 (Immediately Post-Intervention)
50-Meter Dash Time (seconds)
Time required to complete a 50-meter sprint, recorded in seconds.
Measured: Baseline and Week 12 (Immediately Post-Intervention)
8×50-Meter Shuttle Run Time (seconds)
Total time required to complete eight 50-meter shuttle runs, recorded in seconds.
Measured: Baseline and Week 12 (Immediately Post-Intervention)
Rope Skipping Performance (repetitions per minute)
Number of rope skipping repetitions completed within one minute.
Measured: Baseline and Week 12 (Immediately Post-Intervention)
Sit-Ups Performance (repetitions per minute)
Number of sit-ups completed within one minute.
Measured: Baseline and Week 12 (Immediately Post-Intervention)
Sit-and-Reach Distance (centimeters)
Maximum forward reach distance measured in centimeters using a standardized sit-and-reach test.
Measured: Baseline and Week 12 (Immediately Post-Intervention)
Body Mass Index (kg/m²)
Body mass index calculated from measured height and weight (kg/m²).
Measured: Baseline and Week 12 (Immediately Post-Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Sep 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Fang, Anhui Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452302
- Sponsor's protocol ID
- AHNU-MIXPE-LBC-01
- Acronym
- MIXPE-LBC
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07452302
- Acronym / sponsor ID
- MIXPE-LBC / AHNU-MIXPE-LBC-01
- Conditions
- Mental Health, Physical Fitness, Left-Behind Children
- Keywords
- left-behind children, school-based intervention, physical education, sports games, ball sports, randomized controlled trial, child mental health, aerobic fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Anhui Normal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mixed Training Group (MTG) | Experimental | Behavioral: Mixed Physical Education ProgramParticipants 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. |
| Usual Physical Education Control Group (CONG) | Active comparator | Behavioral: Usual Physical EducationParticipants 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. |
Who may qualify
- Ages
- 12 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed Physical Education ProgramParticipants 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. | Behavioural | Mixed Training Group (MTG) |
| Usual Physical EducationParticipants 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. | Behavioural | Usual Physical Education Control Group (CONG) |
Primary outcome
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.
9 secondary outcomes
Interpersonal Anxiety (MHT Subscale Score)
Time frame: Baseline and Week 12 (Immediately Post-Intervention)
Self-Blame Tendency (MHT Subscale Score)
Time frame: Baseline and Week 12 (Immediately Post-Intervention)
Vital Capacity (mL)
Time frame: Baseline and Week 12 (Immediately Post-Intervention)
50-Meter Dash Time (seconds)
Time frame: Baseline and Week 12 (Immediately Post-Intervention)
8×50-Meter Shuttle Run Time (seconds)
Time frame: Baseline and Week 12 (Immediately Post-Intervention)
Rope Skipping Performance (repetitions per minute)
Time frame: Baseline and Week 12 (Immediately Post-Intervention)
Sit-Ups Performance (repetitions per minute)
Time frame: Baseline and Week 12 (Immediately Post-Intervention)
Sit-and-Reach Distance (centimeters)
Time frame: Baseline and Week 12 (Immediately Post-Intervention)
Body Mass Index (kg/m²)
Time frame: Baseline and Week 12 (Immediately Post-Intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Physical Education Program and Usual Physical Education in people with Mental Health and Physical Fitness, run by Anhui Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Test (MHT) Total Score (time frame: Baseline and Week 12 (Immediately Post-Intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.