跳至主要内容
临床试验/NCT07521579
NCT07521579进行中(未招募)不适用

A School-based to Prevent Obesity Among Children Aged 4-7 Years: A Feasibility Quasi-Experimental Trial in Karachi, Pakistan

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Change in teacher's knowledge related to diet, physical activity and sedentary behavior of children aged 4-7 years assessed using the Teacher's questionnaire

研究概览

简要总结

Obesity is a chronic, complex disease that can harm one's health; obesity is characterized by excessive fat deposits. In 2022, 37 million children under the age of 5 were overweight. Over 390 million children and adolescents aged 5-19 years were overweight in 2022, including 160 million who were living with obesity. Childhood obesity can increase the risk of chronic diseases later in life. According to the World Obesity Federation, 5.4 million Pakistani school-aged children will be obese by 2030, thus identified as a leading public health problem. Obesity is a multifactorial problem, and several stakeholders are responsible. From only 8% in 1990 to 20% in 2022, the prevalence of overweight (including obesity) among children and adolescents aged 5-19 has increased significantly. Similar increases have been seen in boys and girls: in 2022, 21% of boys and 19% of girls were overweight. In addition to genetic factors, there are several environmental factors responsible, such as excessive intake of a caloric-dense diet and lack of physical activity. Thus, early childhood interventions are highly recommended to prevent or minimize the risk of being overweight and obese. To reduce obesity among children, school-based healthy lifestyle interventions are identified as a useful setting, as children from different socioeconomic statuses spend a number of hours at school, have one to two lunches, and have opportunities for sports or physical activity.

In Pakistan, few studies are conducted to assess the risk factors contributing to obesity in early childhood. For instance, the results of the Nutritional Assessment among School-going Children in Lahore, Pakistan (NASCL) study were conducted to assess the lifestyle (diet, physical activity, and its association with the weight status and socio-demographic status of primary school children. Results revealed that 57% of children consumed fast food less than a week, whereas 30% consumed it 1-2 times per week and 13% more than three times a week. Moreover, an inverse relationship was found between physical activity, overweight, and obesity (P = 0.001). Similarly, the School Health Education Program in Pakistan (SHEPP) was recently initiated, targeting children aged 8-11 years enrolled in the schools to promote healthy diet and physical activity among 9-11-year-old children.

Approximately 29.8% of school-age children in Pakistan are estimated to be overweight or obese, making childhood obesity a serious public health concern. Sedentary lifestyles and longer sleep durations relative to children of normal weight are risk factors for obesity in Pakistani school children. The Toybox study is a multidisciplinary, evidence-based intervention initiated to reduce obesity in early childhood. The focus is on promoting a healthy diet, consumption of healthy drinks, and physical activity. This study is already implemented in six European countries, namely Belgium, Bulgaria, Greece, Germany, Poland, and Spain, and involved 266 kindergartens; 8709 children and their caregivers were enrolled. One of the strengths of the Toybox study is room for slight adjustments to adapt to the policies, political structures, economic conditions, and cultural attitudes (towards diet and physical activity) of other countries; thus, the first feasibility study outside Europe is planned in Malaysia, which is a Southeast Asian country. To the best of our knowledge, there are no obesity prevention initiatives targeting children (4-7 years of age); hence, we considered it appropriate to start the Toybox Study in Pakistan, as it could be a useful intervention to alleviate the obesity issue, given the high prevalence of childhood obesity in Pakistan. The proposed project will implement culturally specific health promotion to improve the health and well-being of the Pakistani population. We aim to conduct a project in 2 government and 2 private schools located in the District East of Karachi.

The proposed project will target the following Sustainable Development Goals (SDGs): "Good Health and Well-being" (SDG 3).

Obesity is the main driver for the number of chronic diseases. Thus, prevention of childhood obesity can reduce the burden of chronic diseases like diabetes, hypertension, cardiovascular diseases, and a few cancers later in life and decrease morbidity and mortality, along with improving quality of life by reducing the triple burden of disease. In order to lower early death from NCDs and to promote healthy lives for all children, it is imperative that childhood obesity be addressed. Encouraging healthy behaviors from an early age requires a multi-sectoral, comprehensive approach.

详细描述

Problem Statement: Childhood obesity is rising in Pakistan, yet interventions especially those involving school communities, parents and teachers are scarce. This study aims to fill that void. Preventing childhood obesity can significantly reduce the risk of developing chronic conditions and NCDs such as diabetes, hypertension, cardiovascular diseases, and certain cancers later in life. Addressing childhood obesity is critical to lowering premature deaths caused by NCDs and promoting healthier lives for all children. This aligns directly with Sustainable Development Goal 3 (SDG 3): "Good Health and Well-being," which emphasizes ensuring healthy lives and promoting well-being for people of all ages.

Research Objectives: The aim of this study is to assess the preliminary effectiveness of implementing a school-based intervention to reduce obesity among children aged 4-6 in Karachi, Pakistan.

Objectives

  1. To develop a culturally specific Toybox study, a school-based intervention for preventing obesity among children aged 4-7 years in Karachi, Pakistan, by evaluating school facilities, policies, and practices related to healthy diet, physical activity, and clean drinking water, and exploring the perceptions, barriers, and training needs of teachers and parents.
  2. To check the socio-demographics, anthropometric measurements and dietary intake of the children (4-7 years) enrolled in government pre-primary schools of Karachi
  3. To determine the effectiveness of a culturally specific Toybox study intervention for a healthy lifestyle (diet, drinks, and physical activity) for selected participants.

Scope of Research:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 4-7 years of either gender whose parents provide consent and actively engage in the intervention.
  • Schools willing to participate in the study and allow the intervention in their premises
  • Teachers who provided consent and are currently teaching in that school to the children of this age group

排除标准

  • Children with existing diagnosed chronic diseases or medical conditions that affect growth or metabolism (e.g., food allergies, endocrine disorders, severe asthma, physical disabilities that limit activity).
  • Children currently enrolled in other weight management or obesity-related interventions

研究组 & 干预措施

quasi experimental study

Other

This would be a quasi experimental study in which students and parents knowledge will be analyzed pre and post intervention on healthy eating, drinking and promotion of physical activity.

干预措施: Lifestyle Management (Behavioral)

结局指标

主要结局

Change in teacher's knowledge related to diet, physical activity and sedentary behavior of children aged 4-7 years assessed using the Teacher's questionnaire

时间窗: January 2026-April 2026 (4 months)

A validated structured Teacher questionnaire will be used to assess teacher knowledge related to diet, physical activity, and sedentary behavior of children aged 4-7 years. The questionnaire consists of 15 items evaluating the mentioned health behaviors. Each question will have multiple choice answers with one correct answer. The correct answer will be coded as "1" and the incorrect answer as "0". There will be a maximum score of 15 and a minimum of 0. Higher total knowledge scores indicate better knowledge of recommended health behaviors.

Change in teacher's attitude related to diet, physical activity and sedentary behavior of children aged 4-7 years, assessed using the Teacher's questionnaire

时间窗: January 2026-April 2026 (4 months)

A validated structured Teacher's questionnaire will be used to assess teacher attitude related to diet, physical activity, and sedentary behavior of children aged 4-7 years based on a Likert scale. The questionnaire consists of 19 items evaluating teachers' attitudes towards the mentioned health behaviors measured on a 5 point Likert scale: 1= Strongly Disagree, 2= Disagree, 3= Neither agree nor disagree, 4= Agree and 5= Strongly agree. The scoring will range from a minimum score of 19 (if all responses are "Strongly Disagree") to a maximum score of 95 (if all responses are "Strongly agree"). Higher score indicates positive attitude related to diet, physical activity and sedentary behavior

Change in teacher practices related to diet, physical activity and sedentary behavior of children aged 4-7 years assessed using the Teacher's questionnaire

时间窗: January 2026-April 2026 (4 months)

A validated structured Teacher's questionnaire will be used to assess teacher practices related to diet, physical activity, and sedentary behavior of children aged 4-7 years based on a Likert scale. The questionnaire consists of 37 items evaluating teachers' practices towards the mentioned health behaviors measured on a 5-point Likert scale: 1= Strongly Disagree, 2= Disagree, 3= Neither agree nor disagree, 4= Agree and 5= Strongly agree. The scoring will range from a minimum score of 37 (if all responses are "Strongly Disagree") to a maximum score of 185 (if all responses are "Strongly agree"). Higher scores indicate healthy teacher practices related to diet, physical activity and sedentary behavior

Change in parent's knowledge related to diet, physical activity and sedentary behavior of children aged 4-7 years, assessed using the Primary caregiver questionnaire

时间窗: January 2026-April 2026(4 months)

The primary care giver questionnaire will be used to assess parents' knowledge related to diet, physical activity, and sedentary behavior of children aged 4-7 years. The questionnaire consists of 14 items evaluating the knowledge of parents on the mentioned health behaviors. Each question will have multiple choice answers with one correct answer. The correct answer will be coded as "1" and the incorrect answer as "0". There will be a maximum score of 14 and a minimum of 0. Higher scores indicate better knowledge of recommended health behaviors.

Change in parent attitude related to diet, physical activity and sedentary behavior of children aged 4-7 years, assessed using the Primary caregiver questionnaire

时间窗: January 2026-April 2026(4 months)

The Primary care giver questionnaire will be used to assess parent attitude related to diet, physical activity, and sedentary behavior of children aged 4-7 years based on a Likert scale. The questionnaire consists of 24 items evaluating parent's' attitudes towards the mentioned health behaviors each rated on a 5 point Likert scale: 1= Strongly Disagree, 2= Disagree, 3= Neither agree nor disagree, 4= Agree and 5= Strongly agree. The scoring will range from a minimum score of 24 (if all responses are "Strongly Disagree") to a maximum score of 120 (if all responses are "Strongly agree"). A higher score indicates a more positive attitude related to diet, physical activity and sedentary behavior.

Change in parent's practices related to diet, physical activity and sedentary behaviors of children aged 4-7 years, assessed using the Primary caregiver questionnaire.

时间窗: January 2026-April 2026 (4 months)

A validated structure questionnaire will be used to assess parent's practices related to diet, physical activity, and sedentary behavior of children aged 4-7 years based on a Likert scale. The questionnaire consists of 48 items evaluating parents' practices towards the mentioned health behaviors measured on a 5-point Likert scale: 1= Strongly Disagree, 2= Disagree, 3= Neither agree nor disagree, 4= Agree and 5= Strongly agree. The scoring will range from a minimum score of 48 (if all responses are "Strongly Disagree") to a maximum score of 240 (if all responses are "Strongly agree"). Higher scores indicate healthier parental practice related to diet, physical activity and sedentary behavior of children aged 4-7 years

Changes in fluid intake of participating children using Food Frequency Questionnaire

时间窗: January 2026-April 2026(4 months)

Fluid intake of participating children will be assessed using the Food Frequency Questionnaire. The unit of measure will be frequency of consumption (times per week) and average amount consumed (milliliters per day) for water and sugar-sweetened beverages. Changes in intake will be assessed from pre-test to post-test. Increase in water consumption and decrease in sugary beverage consumption will indicate healthier behavior.

Changes in dietary intake of participating children using Food Frequency Questionnaire

时间窗: January 2026-April 2026 (4 months)

Dietary intake, including main meals and snacking patterns, will be assessed using a modified Food Frequency Questionnaire (FFQ). The unit of measure will be frequency of consumption (times per day/week) of various food groups (e.g., fruits, vegetables, snacks). Higher frequency of healthy food consumption and lower frequency of unhealthy snack consumption will indicate healthier dietary behavior.

Changes in physical activity of participating children using Pre-PAQ Physical Activity Questionnaire.

时间窗: January 2026-April 2026(4 months)

Physical activity of participating children will be assessed using the Pre-PAQ Physical Activity Questionnaire, which captures activity over a 3-day period. The unit of measure will be time spent in physical activity (minutes per day). Changes in physical activity will be assessed from pre-test to post-test. An increase in time spent in physical activity will indicate healthier behavior.

Changes in screen usage time of participating children using Primary caregiver questionnaire

时间窗: January 2026-April 2026(4 months)

Change in screen time of participating (TV viewing, mobile use) will be assessed using 3 questions in the primary caregiver questionnaire. The unit of measure will be time spent on screen-based activities (hours per day) during weekdays and weekends. Changes in screen time will be assessed from pre-test to post-test. A decrease in screen time will indicate healthier behavior.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sukaina Shabbir

Lecturer

Dow University of Health Sciences

研究点 (1)

Loading locations...

相似试验