Adolescent Mental HealthAFHMNCT07380750
Active Families, Healthy Minds: A Family-Centered School Physical Activity Program for Early Adolescents
A study testing Family-Supported PA Program, School-Only PA Program and Standard Physical Education in people with Adolescent Mental Health and Physical Inactivity, run by Jinan University Guangzhou at 1 site in China.
Trial summary
This study evaluates the effectiveness of a family-centered school physical activity program, titled "Active Families, Healthy Minds," designed to improve mental health among early adolescents (ages 10-14) in China. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Mental Health, Physical Inactivity, Mental Well-being
- What is being tested?
- Family-Supported PA Program, School-Only PA Program and Standard Physical Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled as a student at the participating study schools.
- Aged between 10 and 14 years.
- Provided written parental consent and written student assent.
- Able to comprehend and complete questionnaires in Chinese.
- Judged by the school health team as safe to participate in moderate-intensity physical activity.
Who cannot join
- Having a physician-advised restriction on exercise.
- Suffering from an acute illness at the time of baseline assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Control Trial of a Family-Centered School Physical Activity Program to Improve Early Adolescent Mental Health in China
This study evaluates the effectiveness of a family-centered school physical activity program, titled "Active Families, Healthy Minds," designed to improve mental health among early adolescents (ages 10-14) in China.
In response to high academic pressure and low physical activity levels, this program integrates structured physical education sessions at school with simple, interactive home-based activity routines involving parents. The study compares this family-supported intervention against a standard school-only physical activity program and a wait-list control group. The primary goal is to determine if involving parents in school-based physical activity initiatives leads to better mental well-being, increased habitual physical activity, and stronger family support compared to school-only approaches.
Read the detailed description
Adolescent mental health is a significant public health concern, particularly in China where academic pressure often limits opportunities for physical activity (PA). This cluster randomized controlled trial (RCT) tests a "Active Families, Healthy Minds" program built on Self-Determination Theory (SDT), targeting the satisfaction of basic psychological needs (autonomy, competence, and relatedness).
The study involves three parallel arms:
Intervention Group (Family-Supported Program): Students participate in structured aerobic games during school PE sessions (twice weekly). Additionally, families implement a home component consisting of one weekday and one weekend joint activity. Parents and children co-plan activities using goal sheets and receive weekly prompts via the WeChat app to facilitate planning and positive communication.
Active Control Group: Students receive the same dose of school-based physical activity (frequency, intensity, and content) as the intervention group but without the structured family engagement component or home routines.
Wait-list Control Group: Students continue with the standard school curriculum and routine services without additional intervention.
The primary outcome is mental well-being, measured by the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Secondary outcomes include basic psychological need satisfaction, habitual physical activity levels, physical literacy, exercise enjoyment, exercise motivation, and parental support. Data are collected at baseline and at 2, 4, and 6 months follow-up to assess the trajectory of change.
- Being tested
- Family-Supported PA Program, School-Only PA Program, Standard Physical Education
- Keywords
- Physical Activity, Family-based Intervention, School-based Intervention, Self-Determination Theory, Early Adolescence, Mental Health Promotion, Prevention
- Medical subject headings
- Sedentary Behavior, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Supported PA ProgramBehavioural
Consists of two components:
School component: Structured aerobic games and skills practice delivered by PE teachers twice a week.
Home component: Weekly parent-child joint activity routines (one weekday, one weekend) supported by goal-setting sheets. Parents receive weekly WeChat prompts to facilitate planning and positive communication.
School-Only PA ProgramBehavioural
Consists of structured aerobic games and skills practice delivered by PE teachers twice a week (same frequency and intensity as the family intervention). Participants receive general health education handouts but do not engage in structured family routines or receive home-based support.
Standard Physical EducationBehavioural
Participants continue with the standard school curriculum and routine physical education classes. No additional structured activities or materials are provided during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Family-Supported Intervention | Experimental | Students participate in structured school-based physical activity sessions twice a week. Additionally, families implement weekly home activity routines (one weekday, one weekend) supported by goal-setting sheets and WeChat prompts to foster parental engagement. Receives: Behavioral: Family-Supported PA Program |
| Active Control (School-Only PA) | Active comparator | Students participate in the same structured school-based physical activity sessions (twice a week) as the intervention group. They receive general health handouts but do not engage in structured family routines or receive home-based support. Receives: Behavioral: School-Only PA Program |
| Wait-List Control | Other | Students continue with the standard school curriculum and routine physical education classes. They receive no additional intervention during the study period but are offered educational materials after the final assessment. Receives: Behavioral: Standard Physical Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Well-being (WEMWBS)
Assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The scale contains 14 positively worded items rated on a 5-point Likert scale (from 1 = 'none of the time' to 5 = 'all of the time'). Total scores range from 14 to 70, with higher scores indicating better mental well-being.
Measured: Baseline, 2 months, 4 months, and 6 months
Secondary outcomes (5)
Basic Psychological Need Satisfaction (BPNS)
Assessed using a 21-item scale aligned with autonomy, competence, and relatedness. Higher scores reflect stronger satisfaction of psychological needs.
Measured: Baseline, 2 months, 4 months, and 6 months
Habitual Physical Activity
A composite score derived from a weekly activity checklist and school day/weekend frequency items, aligned with the Physical Activity Questionnaire for adolescents. Higher scores indicate higher activity levels.
Measured: Baseline, 2 months, 4 months, and 6 months
Physical Literacy (PPLI-SC)
Assessed using the Perceived Physical Literacy Instrument (Simplified Chinese version). It consists of 8 items rated on a 5-point Likert scale. Total scores range from 9 to 45, with higher scores reflecting higher perceived physical literacy.
Measured: Baseline, 2 months, 4 months, and 6 months
Parental Support for Physical Activity
Assessed using items from the Activity Support Scale for Multiple Groups (ACTS-MG), measuring modeling, co-participation, transport, and monitoring. Separate scores for fathers and mothers. Higher scores indicate greater support.
Measured: Baseline, 2 months, 4 months, and 6 months
Body Mass Index (BMI)
Calculated as weight in kilograms divided by height in meters squared (kg/m^2). Height and weight were measured by staff using calibrated equipment.
Measured: Baseline, 2 months, 4 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Aug 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent 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
- Cluster randomized controlled trial. Schools were the unit of randomization (clusters), assigned in a 1:1:1 ratio to the intervention, active control, or wait-list control arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinan University Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Ruisi, Jinan University Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380750
- Sponsor's protocol ID
- SBRE-25-0397
- Acronym
- AFHM
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Control Trial of a Family-Centered School Physical Activity Program to Improve Early Adolescent Mental Health in China
- ClinicalTrials.gov ID
- NCT07380750
- Acronym / sponsor ID
- AFHM / SBRE-25-0397
- Keywords
- Physical Activity, Family-based Intervention, School-based Intervention, Self-Determination Theory, Early Adolescence, Mental Health Promotion, Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Jinan University GuangzhouUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 2 Feb 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 study evaluates the effectiveness of a family-centered school physical activity program, titled "Active Families, Healthy Minds," designed to improve mental health among early adolescents (ages 10-14) in China.
In response to high academic pressure and low physical activity levels, this program integrates structured physical education sessions at school with simple, interactive home-based activity routines involving parents. The study compares this family-supported intervention against a standard school-only physical activity program and a wait-list control group. The primary goal is to determine if involving parents in school-based physical activity initiatives leads to better mental well-being, increased habitual physical activity, and stronger family support compared to school-only approaches.
Detailed description
Adolescent mental health is a significant public health concern, particularly in China where academic pressure often limits opportunities for physical activity (PA). This cluster randomized controlled trial (RCT) tests a "Active Families, Healthy Minds" program built on Self-Determination Theory (SDT), targeting the satisfaction of basic psychological needs (autonomy, competence, and relatedness).
The study involves three parallel arms:
Intervention Group (Family-Supported Program): Students participate in structured aerobic games during school PE sessions (twice weekly). Additionally, families implement a home component consisting of one weekday and one weekend joint activity. Parents and children co-plan activities using goal sheets and receive weekly prompts via the WeChat app to facilitate planning and positive communication.
Active Control Group: Students receive the same dose of school-based physical activity (frequency, intensity, and content) as the intervention group but without the structured family engagement component or home routines.
Wait-list Control Group: Students continue with the standard school curriculum and routine services without additional intervention.
The primary outcome is mental well-being, measured by the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Secondary outcomes include basic psychological need satisfaction, habitual physical activity levels, physical literacy, exercise enjoyment, exercise motivation, and parental support. Data are collected at baseline and at 2, 4, and 6 months follow-up to assess the trajectory of change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Cluster randomized controlled trial. Schools were the unit of randomization (clusters), assigned in a 1:1:1 ratio to the intervention, active control, or wait-list control arm.
| Arm | Type | Receives |
|---|---|---|
| Family-Supported Intervention | Experimental | Behavioral: Family-Supported PA ProgramStudents participate in structured school-based physical activity sessions twice a week. Additionally, families implement weekly home activity routines (one weekday, one weekend) supported by goal-setting sheets and WeChat prompts to foster parental engagement. |
| Active Control (School-Only PA) | Active comparator | Behavioral: School-Only PA ProgramStudents participate in the same structured school-based physical activity sessions (twice a week) as the intervention group. They receive general health handouts but do not engage in structured family routines or receive home-based support. |
| Wait-List Control | Other | Behavioral: Standard Physical EducationStudents continue with the standard school curriculum and routine physical education classes. They receive no additional intervention during the study period but are offered educational materials after the final assessment. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Enrolled as a student at the participating study schools.
- Aged between 10 and 14 years.
- Provided written parental consent and written student assent.
- Able to comprehend and complete questionnaires in Chinese.
- Judged by the school health team as safe to participate in moderate-intensity physical activity.
Key exclusion criteria (2 listed)
- Having a physician-advised restriction on exercise.
- Suffering from an acute illness at the time of baseline assessment.
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 |
|---|---|---|
| Family-Supported PA ProgramConsists of two components: School component: Structured aerobic games and skills practice delivered by PE teachers twice a week. Home component: Weekly parent-child joint activity routines (one weekday, one weekend) supported by goal-setting sheets. Parents receive weekly WeChat prompts to facilitate planning and positive communication. | Behavioural | Family-Supported Intervention |
| School-Only PA ProgramConsists of structured aerobic games and skills practice delivered by PE teachers twice a week (same frequency and intensity as the family intervention). Participants receive general health education handouts but do not engage in structured family routines or receive home-based support. | Behavioural | Active Control (School-Only PA) |
| Standard Physical EducationParticipants continue with the standard school curriculum and routine physical education classes. No additional structured activities or materials are provided during the study period. | Behavioural | Wait-List Control |
Primary outcome
Mental Well-being (WEMWBS)
Time frame: Baseline, 2 months, 4 months, and 6 months
Assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The scale contains 14 positively worded items rated on a 5-point Likert scale (from 1 = 'none of the time' to 5 = 'all of the time'). Total scores range from 14 to 70, with higher scores indicating better mental well-being.
5 secondary outcomes
Basic Psychological Need Satisfaction (BPNS)
Time frame: Baseline, 2 months, 4 months, and 6 months
Habitual Physical Activity
Time frame: Baseline, 2 months, 4 months, and 6 months
Physical Literacy (PPLI-SC)
Time frame: Baseline, 2 months, 4 months, and 6 months
Parental Support for Physical Activity
Time frame: Baseline, 2 months, 4 months, and 6 months
Body Mass Index (BMI)
Time frame: Baseline, 2 months, 4 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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 Family-Supported PA Program, School-Only PA Program and Standard Physical Education in people with Adolescent Mental Health and Physical Inactivity, run by Jinan University Guangzhou 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 2 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 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?
This study is still under way. Results are not available in the source record yet.
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 Well-being (WEMWBS) (time frame: Baseline, 2 months, 4 months, and 6 months). 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 4 Feb 2026.