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

NCT07521579 | Active Not Recruiting DMC

• 1 other identifier: Sukaina Shabbir
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Obesity

Keywords

Childhood obesity; Nutritious diet; Physical activity; Screen time

Outcome Measures

Primary Outcomes (10)

• 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

  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.

  January 2026-April 2026 (4 months)

• 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

  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

  January 2026-April 2026 (4 months)

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

  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

  January 2026-April 2026 (4 months)

• 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

  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.

  January 2026-April 2026(4 months)

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

  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.

  January 2026-April 2026(4 months)

• 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.

  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

  January 2026-April 2026 (4 months)

• Changes in fluid intake of participating children using Food Frequency Questionnaire

  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.

  January 2026-April 2026(4 months)

• Changes in dietary intake of participating children using Food Frequency Questionnaire

  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.

  January 2026-April 2026 (4 months)

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

  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.

  January 2026-April 2026(4 months)

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

  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.

  January 2026-April 2026(4 months)

Study Arms (1)

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.

Behavioral: Lifestyle Management

Interventions

Lifestyle Management BEHAVIORAL

Lifestyle Management including special focus on healthy water and beverage intake, snacks and dietary practices, minimizing screen time and increasing physical activity.

quasi experimental study

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 75280, Pakistan

Location

Related Publications (8)

• Reeves S, Poh BK, Chong YT, Lee JAC, Cheah WL, Hafizah YN, Nelson G, Ruzita AT, Koh D, Summerbell C, Essau CA, Gibson EL. From ToyBox Study to eToyBox: Advancing Childhood Obesity Reduction in Malaysian Kindergartens. Int J Environ Res Public Health. 2023 Aug 20;20(16):6614. doi: 10.3390/ijerph20166614.

  PMID: 37623197 BACKGROUND

• Manios Y, Androutsos O, Katsarou C, Iotova V, Socha P, Geyer C, Moreno L, Koletzko B, De Bourdeaudhuij I; ToyBox-study group. Designing and implementing a kindergarten-based, family-involved intervention to prevent obesity in early childhood: the ToyBox-study. Obes Rev. 2014 Aug;15 Suppl 3:5-13. doi: 10.1111/obr.12175.

  PMID: 25047374 BACKGROUND

• Brown T, Smith S, Bhopal R, Kasim A, Summerbell C. Diet and physical activity interventions to prevent or treat obesity in South Asian children and adults: a systematic review and meta-analysis. Int J Environ Res Public Health. 2015 Jan 9;12(1):566-94. doi: 10.3390/ijerph120100566.

  PMID: 25584423 BACKGROUND

• Mushtaq MU, Gull S, Mushtaq K, Shahid U, Shad MA, Akram J. Dietary behaviors, physical activity and sedentary lifestyle associated with overweight and obesity, and their socio-demographic correlates, among Pakistani primary school children. Int J Behav Nutr Phys Act. 2011 Nov 25;8:130. doi: 10.1186/1479-5868-8-130.

  PMID: 22117626 BACKGROUND

• Almas A, Iqbal R, Sabir S, Ghani A, Kazmi K. School health education program in Pakistan (SHEPP)-a threefold health education feasibility trial in schoolchildren from a lower-middle-income country. Pilot Feasibility Stud. 2020 Jun 8;6:80. doi: 10.1186/s40814-020-00625-x. eCollection 2020.

  PMID: 32523724 BACKGROUND

• Gungor NK. Overweight and obesity in children and adolescents. J Clin Res Pediatr Endocrinol. 2014 Sep;6(3):129-43. doi: 10.4274/Jcrpe.1471.

  PMID: 25241606 BACKGROUND

• Dogra SA, Rai K, Barber S, McEachan RR, Adab P, Sheard L; "Childhood Obesity Prevention in Islamic Religious Settings Programme Management Group.". Delivering a childhood obesity prevention intervention using Islamic religious settings in the UK: What is most important to the stakeholders? Prev Med Rep. 2021 Apr 24;22:101387. doi: 10.1016/j.pmedr.2021.101387. eCollection 2021 Jun.

  PMID: 34012766 BACKGROUND

• Lambrinou CP, Androutsos O, Karaglani E, Cardon G, Huys N, Wikstrom K, Kivela J, Ko W, Karuranga E, Tsochev K, Iotova V, Dimova R, De Miguel-Etayo P, M Gonzalez-Gil E, Tamas H, Jancso Z, Liatis S, Makrilakis K, Manios Y; Feel4Diabetes-study group. Effective strategies for childhood obesity prevention via school based, family involved interventions: a critical review for the development of the Feel4Diabetes-study school based component. BMC Endocr Disord. 2020 May 6;20(Suppl 2):52. doi: 10.1186/s12902-020-0526-5.

  PMID: 32370795 BACKGROUND

Related Links

• The ToyBox Study was a kindergarten-based, family-involved intervention aimed at preventing childhood obesity by promoting healthy diet, physical activity, and reduced sedentary behaviour among preschool children using a theory-driven, school-home integr

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Sukaina NA SHABBIR, PhD Candidate

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: April 13, 2026
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)