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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
School-Family Obesity Prevention Program (SFOPP)
BehavioralBehavioral 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
Trial outcomes
Primary outcomes
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.
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