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临床试验/NCT07380750
NCT07380750进行中(未招募)不适用

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

Jinan University Guangzhou1 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2025年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
345
试验地点
1
主要终点
Mental Well-being (WEMWBS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Data analysts were also masked to group assignment.

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

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.

干预措施: 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.

干预措施: 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.

干预措施: Standard Physical Education (Behavioral)

结局指标

主要结局

Mental Well-being (WEMWBS)

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Jinan University Guangzhou
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ma Ruisi

Principal Investigator

Jinan University Guangzhou

研究点 (1)

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