Skip to main content
Clinical Trials/NCT07380750
NCT07380750
Active, not recruiting
Not Applicable

A Cluster Randomized Control Trial of a Family-Centered School Physical Activity Program to Improve Early Adolescent Mental Health in China

Jinan University Guangzhou1 site in 1 country345 target enrollmentStarted: August 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Jinan University Guangzhou
Enrollment
345
Locations
1
Primary Endpoint
Mental Well-being (WEMWBS)

Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

Data analysts were also masked to group assignment.

Eligibility Criteria

Ages
10 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: Family-Supported PA Program (Behavioral)

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.

Intervention: School-Only PA Program (Behavioral)

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.

Intervention: Standard Physical Education (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Basic Psychological Need Satisfaction (BPNS)(Baseline, 2 months, 4 months, and 6 months)
  • Habitual Physical Activity(Baseline, 2 months, 4 months, and 6 months)
  • Physical Literacy (PPLI-SC)(Baseline, 2 months, 4 months, and 6 months)
  • Parental Support for Physical Activity(Baseline, 2 months, 4 months, and 6 months)
  • Body Mass Index (BMI)(Baseline, 2 months, 4 months, and 6 months)

Investigators

Sponsor
Jinan University Guangzhou
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ma Ruisi

Principal Investigator

Jinan University Guangzhou

Study Sites (1)

Loading locations...

Similar Trials