School and Family-Based Obesity Prevention in Pakistani Primary School Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorCentral South University

About this trial

Childhood obesity is increasing rapidly in Pakistan, but there are no large, high-quality studies testing ways to prevent it in schools. This study aims to find out if a 9-month program involving health education, daily physical activity, parent workshops, and regular feedback via WhatsApp or SMS can reduce the number of primary school children who are overweight or obese.

The study is a cluster randomized controlled trial. A total of 26 primary schools in three cities of Punjab (Lahore, Sahiwal, Bahawalnagar) will be randomly assigned to either the intervention group (13 schools) or the control group (13 schools). Children in grades 3, 4, and 5 (aged 6-12 years) will take part.

In the intervention schools, children will receive 18 health education sessions, daily 45 minutes of physical activity, and monthly weight and height checks. Parents will attend three workshops and receive weekly messages and monthly feedback on their child's progress via WhatsApp or SMS. The control schools will continue their usual activities and receive the intervention materials after the study ends.

The main outcome is the change in the proportion of children who are overweight or obese from the start of the study to 9 months later. Secondary outcomes include changes in BMI z-score, waist circumference, physical activity, eating habits, and parents' knowledge. A follow-up assessment at 12 months will check if any benefits last.

Recruitment of schools and children began on January 8, 2026. This is the first cluster randomized trial of its kind in Pakistan. The results will help inform childhood obesity prevention policies in low- and middle-income countries.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 6-12 years enrolled in grades 3, 4, or 5 of selected primary schools in Lahore, Sahiwal, or Bahawalnagar, Pakistan

Written informed consent provided by parent or primary caregiver

Child assent obtained

Children without any medical conditions that prevent participation in physical activities

Disqualifiers

Medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis, or nephritis

Obesity caused by endocrine diseases or side effects of drugs

Abnormal physical development (e.g., dwarfism, gigantism)

Physical deformity (e.g., severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg)

Trial design

Design model

Parallel

Treatments tested in this trial

  • School-Family Obesity Prevention Program (SFOPP)

    Behavioral

    Behavioral intervention based on the Social Ecological Model, delivered over 9 months. Child components: 18 biweekly sessions (40 min each) of health education (nutrition, physical activity, screen time reduction) and thematic workshops; daily 45 minutes of moderate-to-vigorous physical activity; monthly BMI measurement by trained staff; weekly self-weighing. Parent components: three workshops covering health messages, WhatsApp training, and feedback on child's progress; encouragement of 30-60 minutes daily activity outside school. mHealth: weekly automated WhatsApp/SMS messages with health tips; monthly personalized feedback on child's BMI and behavior change. Tiered system for parents without smartphones (SMS or paper booklets). Fidelity monitoring via field observations and digital logs.

Treatment groups

2,340 Participants
are divided into 2 treatment groups
Group A: School and Family-Based Multifaceted InterventionExperimental treatment 1 intervention
Group B: Usual Practice (Control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Prevalence of Overweight and Obesity

Combined prevalence of overweight and obesity defined according to WHO child growth standards (BMI-for-age z-score). Overweight: z-score \> +1 SD; Obesity: z-score \> +2 SD.

Time frame
Measured at 9 months from baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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