NCT07380750

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
345

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

January 24, 2026

Last Update Submit

February 1, 2026

Conditions

Keywords

Physical ActivityFamily-based InterventionSchool-based InterventionSelf-Determination TheoryEarly AdolescenceMental Health PromotionPrevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 2 months, 4 months, and 6 months

Secondary Outcomes (5)

  • 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

Study Arms (3)

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.

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.

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.

Behavioral: Standard Physical Education

Interventions

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.

Family-Supported Intervention

Participants continue with the standard school curriculum and routine physical education classes. No additional structured activities or materials are provided during the study period.

Wait-List Control

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.

Active Control (School-Only PA)

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Having a physician-advised restriction on exercise.
  • Suffering from an acute illness at the time of baseline assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Education, Jinan University

Guangzhou, China

Location

MeSH Terms

Conditions

Sedentary BehaviorPsychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analysts were also masked to group assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 2, 2026

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations