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School and Family-Based Multifaceted Intervention Program for Preventing Obesity in Primary School Children in Pakistan: A Cluster Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Pakistan
Selected Primary Schools in Lahore, Sahiwal, and Bahawalnagar, Punjab, Pakistan
RECRUITING
Lahore
Contact Information
Primary
Binish Islam, PHD
binish.islam@hotmail.com
+8618874091157
Backup
Tasiu Ibraheem Ibraheem, PHD
218219008@csu.edu.cn
Time Frame
Start Date: 2025-12-08
Estimated Completion Date: 2026-12-08
Participants
Target number of participants: 2340
Treatments
Experimental: School and Family-Based Multifaceted Intervention
A 9-month multifaceted program based on the Social Ecological Model. Components: 18 child health education sessions (12 seminars + 6 workshops, 40 min each, biweekly); daily 45 minutes of moderate-to-vigorous physical activity; three parent workshops covering health messages and child progress feedback; monthly BMI monitoring with personalized feedback via WhatsApp/SMS; weekly automated messages for behavior tracking; tiered communication (WhatsApp, SMS, or paper booklets) to ensure all parents can participate. Fidelity monitored through field observations and digital logs.
No_intervention: Usual Practice (Control)
Schools continue their usual curriculum without any structured obesity prevention program. Routine physical education classes, standard school health checks if available, and no structured nutrition education or family engagement activities related to obesity prevention. After the 12-month follow-up assessment, control schools will be offered the full intervention materials and training
Related Therapeutic Areas
Sponsors
Leads: Central South University

This content was sourced from clinicaltrials.gov