- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07380750
Active Families, Healthy Minds: A Family-Centered School Physical Activity Program for Early Adolescents (AFHM)
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Guangzhou, China
- School of Physical Education, Jinan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Having a physician-advised restriction on exercise.
- Suffering from an acute illness at the time of baseline assessment.
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 |
|---|---|
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Experimental: Family-Supported Intervention
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.
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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. |
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Active Comparator: Active Control (School-Only PA)
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.
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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.
|
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Other: Wait-List Control
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.
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Participants continue with the standard school curriculum and routine physical education classes.
No additional structured activities or materials are provided during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mental Well-being (WEMWBS)
Time Frame: Baseline, 2 months, 4 months, and 6 months
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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.
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Baseline, 2 months, 4 months, and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Basic Psychological Need Satisfaction (BPNS)
Time Frame: Baseline, 2 months, 4 months, and 6 months
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Assessed using a 21-item scale aligned with autonomy, competence, and relatedness.
Higher scores reflect stronger satisfaction of psychological needs.
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Baseline, 2 months, 4 months, and 6 months
|
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Habitual Physical Activity
Time Frame: Baseline, 2 months, 4 months, and 6 months
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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.
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Baseline, 2 months, 4 months, and 6 months
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Physical Literacy (PPLI-SC)
Time Frame: Baseline, 2 months, 4 months, and 6 months
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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.
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Baseline, 2 months, 4 months, and 6 months
|
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Parental Support for Physical Activity
Time Frame: Baseline, 2 months, 4 months, and 6 months
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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.
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Baseline, 2 months, 4 months, and 6 months
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Body Mass Index (BMI)
Time Frame: Baseline, 2 months, 4 months, and 6 months
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Calculated as weight in kilograms divided by height in meters squared (kg/m^2).
Height and weight were measured by staff using calibrated equipment.
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Baseline, 2 months, 4 months, and 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- SBRE-25-0397
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
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