School- and Family-Based Lifestyle Programme for Primary School Children in Punjab, Pakistan: A Feasibility Study
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
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Bahāwalnagar、パキスタン
- Participating primary schools, Lahore
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Lahore、パキスタン
- Participating primary schools, Lahore
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Sāhīwāl、パキスタン
- Participating primary schools, Sahiwal
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
School recruitment rate
時間枠：Baseline (before the programme started)
|
Proportion of eligible primary schools that agreed to participate. |
Baseline (before the programme started)
|
|
Child recruitment rate
時間枠：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
時間枠：18 weeks after baseline
|
Proportion of enrolled children followed up at 18 weeks. |
18 weeks after baseline
|
|
Data completeness
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in BMI-for-age z-score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Change in physical activity score
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline to 18 weeks
|
Child-reported usual nightly sleep duration in hours. |
Baseline to 18 weeks
|
|
Change in parental knowledge, attitudes and practices
時間枠：Baseline to 18 weeks
|
Parent questionnaire scores for knowledge, attitudes and practices regarding childhood healthy weight, diet and physical activity. |
Baseline to 18 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Qin Jiabi、Central South University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- XYGW-2026-18-FS
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified individual participant data underlying the results reported in the publication will be shared with researchers who provide a methodologically sound proposal.
IPD 共有時間枠
Beginning after publication of the main results and for 5 years thereafter.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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