School and Family-Based Multifaceted Intervention Program for Preventing Obesity in Primary School Children in Pakistan: A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,340
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究者
Qin jiabi
Professor, Department of Epidemiology and Health Statistics, Kunming Medical University
Central South University