Clinical trial
A School-based to Prevent Obesity Among Children Aged 4-7 Years- A Feasibility Quasi-Experimental Trial in Karachi, Pakistan
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07521579
What this study is about
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 o…
Basic eligibility
Full registry criteria
Treatments and study arms
Lifestyle Management
Lifestyle Management including special focus on healthy water and beverage intake, snacks and dietary practices, minimizing screen time and increasing physical activity.
Primary outcomes
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.
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
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
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.
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.
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
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.
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.
Study locations
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