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

6 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1200

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

7 lat do 11 lat (Dziecko)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Lifestyle programme

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
School recruitment rate
Ramy czasowe: Baseline (before the programme started)

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

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in BMI-for-age z-score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline to 18 weeks

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

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Central South University

Śledczy

  • Główny śledczy: Qin Jiabi, Central South University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 stycznia 2026

Zakończenie podstawowe (Rzeczywisty)

21 maja 2026

Ukończenie studiów (Rzeczywisty)

21 maja 2026

Daty rejestracji na studia

Pierwszy przesłany

6 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 listopada 2026

Pierwszy wysłany (Rzeczywisty)

12 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • XYGW-2026-18-FS

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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