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School- and Family-Based Lifestyle Programme for Primary School Children in Punjab, Pakistan: A Feasibility Study

2026年11月6日 更新者:Qin jiabi、Central South University

A School- and Family-Based Lifestyle Programme for Primary School Children in Punjab, Pakistan: A Feasibility Cluster Non-Randomised Controlled Trial

The goal of this feasibility study was to find out whether a larger trial of a school- and family-based lifestyle programme for primary school children in Punjab, Pakistan, can be carried out successfully. The programme aims to help children aged 7 to 11 years eat more healthily, be more physically active and sleep well, in order to prevent unhealthy weight gain.

The main questions it aimed to answer were:

  • Will schools and families agree to take part, and will children stay in the study until the end?
  • Can measurements and questionnaires be completed fully and within a reasonable time?
  • Can the programme be delivered in schools as planned, and will children and parents attend the sessions?

Ten primary schools in three districts of Punjab (Lahore, Sahiwal and Bahawalnagar) took part. Children in five schools received the 17-week programme, and children in the other five schools continued their usual school routine.

Children in the programme schools:

  • attended a weekly classroom session about healthy eating, physical activity and sleep
  • took part in extra physical activity at school
  • kept a weekly activity diary at home

Their parents were invited to group sessions and two individual meetings, and received printed guidance.

In all schools, children's height, weight, waist size and blood pressure were measured, and children and parents completed questionnaires at the start of the study and after 18 weeks.

研究概览

详细说明

This was a feasibility cluster non-randomised controlled trial. Schools were the unit of allocation: five of the seven schools able to timetable the programme in the spring term received the intervention, and five schools served as controls. To minimise contamination, schools in different groups were at least 3 km apart, served separate catchment areas and shared no teaching staff.

The programme was grounded in the socio-ecological model and targeted children (classroom education, school physical activity and self-monitoring), families (parent group sessions, individual meetings and printed guidance) and schools (daily physical activity opportunities). During Ramadan, school physical activity was suspended and session timing was adjusted.

The standard deviation of change and the intracluster correlation coefficient of BMI-for-age z-score (WHO 2007 reference) were estimated to inform the sample size of the definitive cluster randomised trial. Initial between-group differences in weight status, blood pressure and behaviours were estimated with linear mixed models including a random intercept for school, adjusted for baseline value, age, sex and district.

研究类型

介入性

注册 (实际的)

1200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bahāwalnagar、巴基斯坦
        • Participating primary schools, Lahore
      • Lahore、巴基斯坦
        • Participating primary schools, Lahore
      • Sāhīwāl、巴基斯坦
        • Participating primary schools, Sahiwal

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

7年 至 11年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Children enrolled in grades 3-5 (aged 7-11 years) in a participating primary school
  • Written informed consent from a parent or legal guardian
  • Verbal assent from the child

Exclusion Criteria:

  • Physical disability or chronic condition limiting growth or physical activity, as reported by parents and confirmed by teachers
  • Expected to change school before the 18-week follow-up

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Lifestyle programme

Children in grades 3-5 and their parents in five primary schools received the 17-week school- and family-based lifestyle programme.

A 17-week programme with two components. Child component: 16 weekly 40-minute classroom sessions on healthy eating, physical activity and sleep, each followed by a take-home task; a target of 45 minutes of school physical activity (physical education, classroom activity breaks and after-class sport) on every school day; and weekly self-monitoring with a home exercise diary and self-weighing, with private feedback every four weeks. Parent component: nine 60-minute group sessions paralleling the child curriculum, two individual meetings on the child's growth and behaviour goals, and printed guidance on screen time, family activity, healthy eating and sleep. During Ramadan, school physical activity was suspended and session timing was adjusted.

无干预:Usual practice

Children in five primary schools continued their usual school timetable, including two 35-minute physical education periods per week, and received no study activities. Programme materials were provided to these schools after the study.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
School recruitment rate
大体时间:Baseline (before the programme started)

Proportion of eligible primary schools that agreed to participate.

Baseline (before the programme started)
Child recruitment rate
大体时间:Baseline (before the programme started)

Proportion of eligible children in grades 3-5 whose parents gave written consent.

Baseline (before the programme started)
Retention rate
大体时间:18 weeks after baseline

Proportion of enrolled children followed up at 18 weeks.

18 weeks after baseline
Data completeness
大体时间:Baseline and 18 weeks

Proportion of enrolled children (baseline) and followed-up children (18 weeks) with complete data for each measure: anthropometry, blood pressure, child questionnaire sections and parent questionnaire.

Baseline and 18 weeks
Time needed for data collection
大体时间:Baseline and 18 weeks

Mean minutes per class required to complete the child questionnaire and to measure anthropometry and blood pressure.

Baseline and 18 weeks
Programme delivery and attendance
大体时间:During the 17-week programme

Proportion of planned child and parent sessions delivered; mean attendance (%) of children at classroom sessions and of parents at group sessions; frequency (days per week) and duration (minutes per day) of school physical activity.

During the 17-week programme
Standard deviation of change and intracluster correlation coefficient of BMI-for-age z-score
大体时间:Baseline to 18 weeks

Parameters for the sample size calculation of the definitive trial. BMI-for-age z-score was calculated from measured height and weight using the WHO 2007 growth reference.

Baseline to 18 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in BMI-for-age z-score
大体时间:Baseline to 18 weeks

Calculated from measured height and weight using the WHO 2007 growth reference.

Baseline to 18 weeks
Change in prevalence of overweight and obesity
大体时间:Baseline to 18 weeks

Proportion of children with overweight (BMI-for-age z-score > +1 to +2) or obesity (z-score > +2) according to WHO 2007 cut-offs.

Baseline to 18 weeks
Change in waist circumference
大体时间:Baseline to 18 weeks

Measured in centimetres midway between the lowest rib and the iliac crest.

Baseline to 18 weeks
Change in systolic and diastolic blood pressure
大体时间:Baseline to 18 weeks

Measured in mmHg with a validated oscillometric device; classified using the American Academy of Pediatrics 2017 tables.

Baseline to 18 weeks
Change in physical activity score
大体时间:Baseline to 18 weeks

Child-reported summary score (range 0-19) based on days with at least 60 minutes of activity, days walking or cycling to school, and days with physical education in the past 7 days; higher scores indicate more activity.

Baseline to 18 weeks
Change in diet score
大体时间:Baseline to 18 weeks

Child-reported dietary questionnaire on intake of fruit and vegetables, sugar-sweetened beverages and fast food in the past 7 days.

Baseline to 18 weeks
Change in screen and sedentary time score
大体时间:Child-reported score (range 0-8) from four items on screen and sedentary time, each scored 0-2 (<1 h, 1-2 h, >2 h per day); higher scores indicate more screen time.

Child-reported score (range 0-8) from four items on screen and sedentary time, each scored 0-2 (<1 h, 1-2 h, >2 h per day); higher scores indicate more screen time.

Child-reported score (range 0-8) from four items on screen and sedentary time, each scored 0-2 (<1 h, 1-2 h, >2 h per day); higher scores indicate more screen time.
Change in sleep duration
大体时间:Baseline to 18 weeks

Child-reported usual nightly sleep duration in hours.

Baseline to 18 weeks
Change in parental knowledge, attitudes and practices
大体时间:Baseline to 18 weeks

Parent questionnaire scores for knowledge, attitudes and practices regarding childhood healthy weight, diet and physical activity.

Baseline to 18 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Qin Jiabi、Central South University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月5日

初级完成 (实际的)

2026年5月21日

研究完成 (实际的)

2026年5月21日

研究注册日期

首次提交

2026年11月6日

首先提交符合 QC 标准的

2026年11月6日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in the publication will be shared with researchers who provide a methodologically sound proposal.

IPD 共享时间框架

Beginning after publication of the main results and for 5 years thereafter.

IPD 共享访问标准

Requests should be directed to the corresponding author. Data will be shared after approval of a proposal and signature of a data-sharing agreement, subject to approval by the Institutional Review Board of the Xiangya School of Public Health, Central South University.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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