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

NCT07616232 | Recruiting DMC

• 1 other identifier: CSU-OBESITY-PAK-001
• Study Type: interventional
• Target: 2,340
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Obesity Pevention

Keywords

Obesity prevention; School-based intervention; Family-based intervention; Cluster randomized trial; Primary school children; Childhood obesity

Outcome Measures

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.

  Measured at 9 months from baseline

Study Arms (2)

School and Family-Based Multifaceted Intervention

EXPERIMENTAL

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.

Behavioral: School-Family Obesity Prevention Program (SFOPP)

Usual Practice (Control)

NO INTERVENTION

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

Interventions

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.

School and Family-Based Multifaceted Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Inability to participate in school sport activities
• Weight loss by vomiting or taking drugs during the past three months
• Participation in another obesity prevention or treatment program
• For schools: planned relocation or cancellation within the next two years

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Selected Primary Schools in Lahore, Sahiwal, and Bahawalnagar, Punjab, Pakistan

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qin Jiabi, PHD

  Kunming Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binish Islam, PHD

CONTACT

+8618874091157; binish.islam@hotmail.com

Tasiu Ibraheem Ibraheem, PHD

CONTACT

218219008@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, parents, teachers, and intervention providers cannot be blinded due to the behavioral nature of the intervention. Outcome assessors conducting anthropometric measurements (height, weight, waist circumference) will be blinded to school allocation. The statistician performing the final analysis will also be blinded. Data will be coded to protect blinding during analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Epidemiology and Health Statistics, Kunming Medical University

Model Details: Cluster randomized design. Schools are the unit of randomization. 26 primary schools randomized 1:1 to intervention or control arm (13 schools per arm). Children within schools are the unit of analysis. Randomization stratified by study site (Lahore, Sahiwal, Bahawalnagar). Allocation sequence generated by independent statistician using block randomization.

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 1, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting documents will be available beginning 9 months after publication of the main trial results and ending 36 months after article publication.
• Access Criteria: De-identified individual participant data and the supporting documents listed above will be made available to researchers who provide a methodologically sound proposal. Data will be shared for the purposes of meta-analysis, secondary research, or re-analysis. Requests should be directed to the principal investigator (Qin jiabi, email: qinjiabi123@163.com). Requestors will be required to sign a data access agreement to ensure data are used only for the agreed purpose and that no attempts are made to re-identify participants.

Locations

PA (1)