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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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-
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Bahāwalnagar, Pakistan
- Participating primary schools, Lahore
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Lahore, Pakistan
- Participating primary schools, Lahore
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Sāhīwāl, Pakistan
- Participating primary schools, Sahiwal
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Nessun intervento: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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School recruitment rate
Lasso di tempo: Baseline (before the programme started)
|
Proportion of eligible primary schools that agreed to participate. |
Baseline (before the programme started)
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Child recruitment rate
Lasso di tempo: Baseline (before the programme started)
|
Proportion of eligible children in grades 3-5 whose parents gave written consent. |
Baseline (before the programme started)
|
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Retention rate
Lasso di tempo: 18 weeks after baseline
|
Proportion of enrolled children followed up at 18 weeks. |
18 weeks after baseline
|
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Data completeness
Lasso di tempo: 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
|
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Time needed for data collection
Lasso di tempo: 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
|
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Programme delivery and attendance
Lasso di tempo: 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
|
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Standard deviation of change and intracluster correlation coefficient of BMI-for-age z-score
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in BMI-for-age z-score
Lasso di tempo: Baseline to 18 weeks
|
Calculated from measured height and weight using the WHO 2007 growth reference. |
Baseline to 18 weeks
|
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Change in prevalence of overweight and obesity
Lasso di tempo: 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
|
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Change in waist circumference
Lasso di tempo: Baseline to 18 weeks
|
Measured in centimetres midway between the lowest rib and the iliac crest. |
Baseline to 18 weeks
|
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Change in systolic and diastolic blood pressure
Lasso di tempo: Baseline to 18 weeks
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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
Lasso di tempo: Baseline to 18 weeks
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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
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Change in diet score
Lasso di tempo: 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
|
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Change in screen and sedentary time score
Lasso di tempo: 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.
|
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Change in sleep duration
Lasso di tempo: Baseline to 18 weeks
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Child-reported usual nightly sleep duration in hours. |
Baseline to 18 weeks
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Change in parental knowledge, attitudes and practices
Lasso di tempo: Baseline to 18 weeks
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Parent questionnaire scores for knowledge, attitudes and practices regarding childhood healthy weight, diet and physical activity. |
Baseline to 18 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Qin Jiabi, Central South University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- XYGW-2026-18-FS
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
De-identified individual participant data underlying the results reported in the publication will be shared with researchers who provide a methodologically sound proposal.
Periodo di condivisione IPD
Beginning after publication of the main results and for 5 years thereafter.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
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