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

6 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Pakistan
      • Bahāwalnagar, Pakistan
        • Participating primary schools, Lahore
      • Lahore, Pakistan
        • Participating primary schools, Lahore
      • Sāhīwāl, Pakistan
        • Participating primary schools, Sahiwal

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

7 jaar tot 11 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Lifestyle programme

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
School recruitment rate
Tijdsspanne: Baseline (before the programme started)

Proportion of eligible primary schools that agreed to participate.
Baseline (before the programme started)
Child recruitment rate
Tijdsspanne: 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
Tijdsspanne: 18 weeks after baseline

Proportion of enrolled children followed up at 18 weeks.
18 weeks after baseline
Data completeness
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in BMI-for-age z-score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to 18 weeks

Child-reported usual nightly sleep duration in hours.
Baseline to 18 weeks
Change in parental knowledge, attitudes and practices
Tijdsspanne: Baseline to 18 weeks

Parent questionnaire scores for knowledge, attitudes and practices regarding childhood healthy weight, diet and physical activity.
Baseline to 18 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Central South University

Onderzoekers

  • Hoofdonderzoeker: Qin Jiabi, Central South University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 januari 2026

Primaire voltooiing (Werkelijk)

21 mei 2026

Studie voltooiing (Werkelijk)

21 mei 2026

Studieregistratiedata

Eerst ingediend

6 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • XYGW-2026-18-FS

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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