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

May 31, 2026 updated by: Qin jiabi, Central South University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Design: Two-phase, prospective, parallel-group, cluster-randomized controlled trial (cRCT) with an embedded mixed-methods process evaluation and longitudinal sustainability follow-up. Phase 1: 9-month primary efficacy trial. Phase 2: sustainability assessment at 12 months from baseline (3 months post-intervention).

Setting: 26 primary schools from three cities in Punjab, Pakistan: Lahore, Sahiwal, and Bahawalnagar. These cities represent the socioeconomic and cultural diversity of Punjab, the most populous province of Pakistan.

Randomization: Schools will be randomized 1:1 to intervention or control using computer-generated sequence, stratified by study site. An independent statistician will perform allocation concealment. Outcome assessors and the statistician will be blinded to group assignment. Participants, parents, and school personnel cannot be blinded due to the behavioral nature of the intervention.

Sample Size: 26 schools (13 intervention, 13 control), approximately 90 children per school, total 2,340 children aged 6-12 years in grades 3-5. Sample size calculation assumed a reduction in overweight/obesity prevalence from 36.7% to 26.7% (10% absolute reduction), 80% power, α=0.05, coefficient of variation k=0.15, and 20% attrition buffer.

Intervention (9 months): Developed using the Social Ecological Model and informed by a systematic review (PROSPERO CRD420251242889). Components include:

Child-focused: 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-focused: Three workshops covering health messages, WhatsApp training, and feedback on child's progress; encouragement of 30-60 minutes of daily physical activity outside school.

mHealth component: Weekly automated WhatsApp/SMS messages with health tips and behavior tracking; monthly personalized feedback on child's BMI and behavior change. Tiered system for parents without smartphones (SMS or paper booklets).

Fidelity monitoring: Regular field observations, digital engagement logs, and process evaluation.

Control: Schools continue 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. After the 12-month follow-up, control schools receive intervention materials.

Outcomes:

Primary: Change in prevalence of overweight and obesity (WHO BMI-for-age z-score: overweight >+1 SD, obesity >+2 SD) from baseline to 9 months.

Secondary: Change in BMI z-score, waist circumference, body fat percentage, moderate-to-vigorous physical activity (days/week ≥60 min), daily screen time, dietary behaviors (sugar-sweetened beverages, fried foods, fast food), obesity-related knowledge (child), parental knowledge and self-efficacy, physical fitness (rope jumps, sit-ups, standing jump, shuttle run), and sustainability of BMI z-score change at 12 months.

Data Collection: Baseline (month 0), mid-point (month 6), post-intervention (month 9), sustainability follow-up (month 12). Anthropometric measurements (height, weight, waist/hip circumference, body fat percentage), blood pressure, physical fitness tests, and validated child/parent questionnaires.

Statistical Analysis: Intention-to-treat principle using generalized linear mixed models accounting for clustering. Primary outcome: binary prevalence analyzed with binomial distribution and logit link, adjusting for baseline values and stratification factors. Secondary continuous outcomes: mixed models with random intercept for school. Missing data <5% will use maximum likelihood; >5% sensitivity with last-value-carried-forward. Subgroup analyses by region, sex, maternal education, baseline BMI status, and primary caregiver. All tests two-sided α=0.05. Analysis will use SAS 9.4.

Process Evaluation: Concurrent mixed-methods evaluation guided by the EPIS framework to assess fidelity, dose, reach, adaptation, barriers, and facilitators. Quantitative metrics (reach, adoption, implementation fidelity, engagement logs) and qualitative interviews/focus groups with principals, teachers, and parents.

Ethics: Approved by Central South University Institutional Review Board (approval number XYGW-2026-18). Written parental consent and child verbal assent required. Data anonymized and securely stored. Study follows Declaration of Helsinki and local guidelines.

Trial Status: Recruitment began December 8, 2025. Planned primary completion September 8, 2026; study completion December 8, 2026.

Funding/Support: National Natural Science Foundation of China (as per proposal page 1). Sponsor: Central South University.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • Selected Primary Schools in Lahore, Sahiwal, and Bahawalnagar, Punjab, Pakistan
        • Contact:
        • Contact:
        • Principal Investigator:
          • Binish Islam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: School-Family Obesity Prevention Program (SFOPP)
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Prevalence of Overweight and Obesity
Time Frame: Measured at 9 months from baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qin Jiabi, PHD, Kunming Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSU-OBESITY-PAK-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie the results reported in the main publication will be available after de-identification. Additional documents such as the study protocol, statistical analysis plan, and informed consent form will also be shared. Data will be available beginning 9 months and ending 36 months after article publication to researchers who provide a methodologically sound proposal. Proposals should be directed to the principal investigator (Qin jiabi, email: qinjiabi123@163.com. To gain access, requestors will need to sign a data access agreement.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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