Childhood ObesityNCT07521579
A School-based to Prevent Obesity Among Children Aged 4-7 Years- A Feasibility Quasi-Experimental Trial in Karachi, Pakistan
A study testing Lifestyle Management in people with Childhood Obesity, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A School-based to Prevent Obesity Among Children Aged 4-7 Years: A Feasibility Quasi-Experimental Trial in Karachi, Pakistan
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.
Read more
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.
Read the detailed description
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
- 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.
- To check the socio-demographics, anthropometric measurements and dietary intake of the children (4-7 years) enrolled in government pre-primary schools of Karachi
- 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: Research Significance: This study will address and minimize the issue of childhood obesity, as it is a major driver of chronic diseases. 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. By tackling childhood obesity, this intervention contributes to achieving SDG 3 targets, particularly those focused on reducing premature mortality from NCDs, strengthening the prevention and treatment of health risks, and fostering sustainable health and well-being from an early age.
- Public Health Impact: Addresses the rising concern of childhood obesity in Karachi, a major urban area in Pakistan.
- Culturally Relevant Intervention: Adaptation of Toybox study allows tailored strategies suitable to local customs, resources, and barriers.
- Parental and Teacher Engagement: Enhances sustainability by involving primary influencers of children's daily environment.
- Policy and Practice Implications: Can inform school health policies and programs promoting healthier lifestyles in children.
- Model for Other Regions: Successful replication may provide a scalable model for other cities or regions facing similar health challenges.
- Early Prevention: Targeting pre-primary school children facilitates early intervention, reducing future health risks associated with obesity.
- Community Awareness: Raises awareness among families and educators about the importance of preventive health measures for children. This research is relevant in the context of increasing childhood obesity rates globally and locally, contributing valuable evidence to guide effective interventions in school settings with community involvement. RESEARCH METHODOLOGY
- Design:
- Study Design: Quasi-experimental study, one-group pretest and posttest study design. All the suggested interventions by the original Toy box study (intake of a healthy snack, healthy drinks, increase in physical activity, and reducing screen time) with known efficacy will be included. Thus, it will be unethical to include a control group Duration of Study: 10 months after ethical approval from the institute. In the first 3 months we will be conducting qualitative interviews and work on development of a culturally specific intervention. In the next 3 months we will be implementing the intervention developed in the school , while the intervention assessment period will extend to four months to accommodate school holidays and examination schedules.
- Study Population: The data will be collected from parents and teachers of children between 4-7 years of age attending Government and private schools of Karachi
- Sample Size: Using PASS version 11, two-sided paired z-test a sample size of 22 achieves power 95% to detect a mean of paired differences of outdoor active play in intervention group was 4.5 [11] with standard deviation of paired differences of 4.54 [11] significance level (alpha) of 0.01. To improve the reliability and validity of our quasi-experimental study, we plan to raise the sample size from 22 to 30 participants. With this modification, we want to increase the statistical power of our findings and more reliable outcomes.
- Sampling Technique: A non-probability, convenience sampling method will be used for both qualitative and quantitative data collection. Sample Selection: The qualitative and quantitative data will be collected from parents and teachers of children between 4-7 years of age attending government and private schools located in the District East of Karachi, Pakistan. Schools from District East was selected due to accessibility and feasibility of data collection, to allow timely implementation of the study.
- Data Collection Procedure:
- Ethical Consideration: Study protocol was submitted to obtain approval from the Institutional Review Board (IRB) of Dow University of Health Sciences, Karachi, Pakistan (IRB-3847/DUHS/Approval/2025/177). Informed consent will be obtained from all participating parents and teachers before collecting data. Participation will be entirely voluntary, and participants will be informed of their right to withdraw from the study at any stage without any penalty. All data collected will be kept strictly confidential and will be used for research purposes only and access will be limited to the research team only.
- Study Phases: This study is conducted in four phases. Brief detail on the four phases is given below:
- Phase one (Needs Assessment): An assessment was conducted to evaluate school facilities ( drinking water availability, healthy diet, physical activity opportunities) using an interview administered questionnaire. Focus group discussions were conducted with parents and teachers to assess their perspectives on the importance of healthy lifestyle in early childhood, barriers in providing healthy diet at school and home and training required to promote healthy behaviors. Results from FGDs helped modify the Toybox material according to Pakistan's cultural context.
- Phase two (Baseline data collection): Baseline data were collected from teachers and parents to evaluate their knowledge, practices and attitudes regarding promotion of healthy snacking, drinking water, physical activity and screen time Data included anthropometric measurements, dietary and fluid intake, physical activity and screen time. All variables will be measured before and after the intervention.
- Phase three (Planning Phase): Educational material (posters, booklet, teacher activity guide book, educational videos) were developed in English and then translated to Urdu. The material will be age appropriate and culturally specific to Pakistan's context. Teachers will be trained to deliver the developed educational material effectively focusing on healthy snacking, water intake, physical activity and screen time.
- Phase four(Implementation Phase): The teachers will conduct interactive sessions using the activity guidebook. Parents will receive educational brochures and short videos on healthy diet, water intake, physical activity and screen time. The duration of the intervention will be 3 active months. The intervention assessment period will extend to four months to accommodate school holidays and examination schedules.
- Study Instruments:
- Qualitative Data: Focus group discussions (FGDs): Qualitative data was collected using FGDs with both parents and teachers to assess their knowledge, attitudes and perceptions on child nutrition, physical activity and sedentary activities. A semi structured FGD guide was developed based on study objectives. FGDs were audio recorded, transcribed and translated to English and analyzed using thematic analysis.
- Quantitative Data:
- Audit questionnaire: A questionnaire to evaluate the school's environment.
- Primary care giver questionnaire: A questionnaire was administered to parents to collect information on the family background and lifestyle factors(such as parental education, occupation, child's sleeping patterns), parental and child behaviors including fluid intake, snacking patterns, physical activity and screen time. This questionnaire also includes questions on the child's medical history. The questionnaire was translated to Urdu and back translated to English.
- Teacher's questionnaire: A questionnaire was administered to teachers to collect information on classroom environment and school practices related to snacking, fluid intake, physical activity and screen usage. This questionnaire also assessed teachers knowledge, practice and attitudes related to healthy snacking, fluid intake, PA and sedentary behavior.
- Socioeconomic status: Sociodemographic data were collected, keeping in mind the objectives of the study, including age of parents, ethnicity, education, number of children, profession, family structure and family income.
- Anthropometric measurements: Weight (kg), height (cm) and waist circumference (cm) of the participating children were collected at baseline and will be collected again after intervention.
- Dietary Assessment: Dietary intake: Diet including main meals and snacking patterns was assessed using a validated, modified version of the ToyBox Food Frequency Questionnaire (FFQ) administered by a research assistant. The FFQ was translated in Urdu and back translated to English. A generic food photograph atlas was used to assist participants in estimating portion sizes. Fluid Intake: Was assessed using a modified version of ToyBox Food frequency questionnaire administered by a research assistant. The FFQ was translated in Urdu and back translated to English. A generic food photograph atlas was used to assist participants in identifying portion sizes.
- Physical activity: The physical activity of preschoolers was evaluated using the Pre-PAQ Physical Activity Questionnaire. Pre-PAQ is a three-day activity questionnaire used to assess a child's habitual level of physical activity and sedentary behavior at home. This questionnaire was translated to Urdu and back translated into English.
- Sedentary behavior (including screens and quiet play): Was assessed by 3 questions in the primary care giver questionnaire. These questions assess the number of hours spent on screens and quiet play during weekdays and weekends.
- Conditions
- Childhood Obesity
- Being tested
- Lifestyle Management
- Keywords
- Childhood obesity, Nutritious diet, Physical activity, Screen time
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementBehavioural
Lifestyle Management including special focus on healthy water and beverage intake, snacks and dietary practices, minimizing screen time and increasing physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: January 2026-April 2026(4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Sep 2025
- Primary completionApr 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukaina Shabbir, Dow University of Health Sciences
- Investigators
- Sukaina NA SHABBIR, PhD Candidate, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521579
- Sponsor's protocol ID
- Sukaina Shabbir
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To keep confidentiality of data
Publications
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.
PubMed 37623197Manios 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.
PubMed 25047374Brown 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.
PubMed 25584423Mushtaq 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.
PubMed 22117626Almas 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.
PubMed 32523724Gungor NK. Overweight and obesity in children and adolescents. J Clin Res Pediatr Endocrinol. 2014 Sep;6(3):129-43. doi: 10.4274/Jcrpe.1471.
PubMed 25241606Dogra 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.
PubMed 34012766Lambrinou 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.
PubMed 32370795
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-based to Prevent Obesity Among Children Aged 4-7 Years: A Feasibility Quasi-Experimental Trial in Karachi, Pakistan
- ClinicalTrials.gov ID
- NCT07521579
- Acronym / sponsor ID
- Sukaina Shabbir
- Conditions
- Childhood Obesity
- Keywords
- Childhood obesity, Nutritious diet, Physical activity, Screen time
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 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.
- To check the socio-demographics, anthropometric measurements and dietary intake of the children (4-7 years) enrolled in government pre-primary schools of Karachi
- 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: Research Significance: This study will address and minimize the issue of childhood obesity, as it is a major driver of chronic diseases. 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. By tackling childhood obesity, this intervention contributes to achieving SDG 3 targets, particularly those focused on reducing premature mortality from NCDs, strengthening the prevention and treatment of health risks, and fostering sustainable health and well-being from an early age.
- Public Health Impact: Addresses the rising concern of childhood obesity in Karachi, a major urban area in Pakistan.
- Culturally Relevant Intervention: Adaptation of Toybox study allows tailored strategies suitable to local customs, resources, and barriers.
- Parental and Teacher Engagement: Enhances sustainability by involving primary influencers of children's daily environment.
- Policy and Practice Implications: Can inform school health policies and programs promoting healthier lifestyles in children.
- Model for Other Regions: Successful replication may provide a scalable model for other cities or regions facing similar health challenges.
- Early Prevention: Targeting pre-primary school children facilitates early intervention, reducing future health risks associated with obesity.
- Community Awareness: Raises awareness among families and educators about the importance of preventive health measures for children. This research is relevant in the context of increasing childhood obesity rates globally and locally, contributing valuable evidence to guide effective interventions in school settings with community involvement. RESEARCH METHODOLOGY
- Design:
- Study Design: Quasi-experimental study, one-group pretest and posttest study design. All the suggested interventions by the original Toy box study (intake of a healthy snack, healthy drinks, increase in physical activity, and reducing screen time) with known efficacy will be included. Thus, it will be unethical to include a control group Duration of Study: 10 months after ethical approval from the institute. In the first 3 months we will be conducting qualitative interviews and work on development of a culturally specific intervention. In the next 3 months we will be implementing the intervention developed in the school , while the intervention assessment period will extend to four months to accommodate school holidays and examination schedules.
- Study Population: The data will be collected from parents and teachers of children between 4-7 years of age attending Government and private schools of Karachi
- Sample Size: Using PASS version 11, two-sided paired z-test a sample size of 22 achieves power 95% to detect a mean of paired differences of outdoor active play in intervention group was 4.5 [11] with standard deviation of paired differences of 4.54 [11] significance level (alpha) of 0.01. To improve the reliability and validity of our quasi-experimental study, we plan to raise the sample size from 22 to 30 participants. With this modification, we want to increase the statistical power of our findings and more reliable outcomes.
- Sampling Technique: A non-probability, convenience sampling method will be used for both qualitative and quantitative data collection. Sample Selection: The qualitative and quantitative data will be collected from parents and teachers of children between 4-7 years of age attending government and private schools located in the District East of Karachi, Pakistan. Schools from District East was selected due to accessibility and feasibility of data collection, to allow timely implementation of the study.
- Data Collection Procedure:
- Ethical Consideration: Study protocol was submitted to obtain approval from the Institutional Review Board (IRB) of Dow University of Health Sciences, Karachi, Pakistan (IRB-3847/DUHS/Approval/2025/177). Informed consent will be obtained from all participating parents and teachers before collecting data. Participation will be entirely voluntary, and participants will be informed of their right to withdraw from the study at any stage without any penalty. All data collected will be kept strictly confidential and will be used for research purposes only and access will be limited to the research team only.
- Study Phases: This study is conducted in four phases. Brief detail on the four phases is given below:
- Phase one (Needs Assessment): An assessment was conducted to evaluate school facilities ( drinking water availability, healthy diet, physical activity opportunities) using an interview administered questionnaire. Focus group discussions were conducted with parents and teachers to assess their perspectives on the importance of healthy lifestyle in early childhood, barriers in providing healthy diet at school and home and training required to promote healthy behaviors. Results from FGDs helped modify the Toybox material according to Pakistan's cultural context.
- Phase two (Baseline data collection): Baseline data were collected from teachers and parents to evaluate their knowledge, practices and attitudes regarding promotion of healthy snacking, drinking water, physical activity and screen time Data included anthropometric measurements, dietary and fluid intake, physical activity and screen time. All variables will be measured before and after the intervention.
- Phase three (Planning Phase): Educational material (posters, booklet, teacher activity guide book, educational videos) were developed in English and then translated to Urdu. The material will be age appropriate and culturally specific to Pakistan's context. Teachers will be trained to deliver the developed educational material effectively focusing on healthy snacking, water intake, physical activity and screen time.
- Phase four(Implementation Phase): The teachers will conduct interactive sessions using the activity guidebook. Parents will receive educational brochures and short videos on healthy diet, water intake, physical activity and screen time. The duration of the intervention will be 3 active months. The intervention assessment period will extend to four months to accommodate school holidays and examination schedules.
- Study Instruments:
- Qualitative Data: Focus group discussions (FGDs): Qualitative data was collected using FGDs with both parents and teachers to assess their knowledge, attitudes and perceptions on child nutrition, physical activity and sedentary activities. A semi structured FGD guide was developed based on study objectives. FGDs were audio recorded, transcribed and translated to English and analyzed using thematic analysis.
- Quantitative Data:
- Audit questionnaire: A questionnaire to evaluate the school's environment.
- Primary care giver questionnaire: A questionnaire was administered to parents to collect information on the family background and lifestyle factors(such as parental education, occupation, child's sleeping patterns), parental and child behaviors including fluid intake, snacking patterns, physical activity and screen time. This questionnaire also includes questions on the child's medical history. The questionnaire was translated to Urdu and back translated to English.
- Teacher's questionnaire: A questionnaire was administered to teachers to collect information on classroom environment and school practices related to snacking, fluid intake, physical activity and screen usage. This questionnaire also assessed teachers knowledge, practice and attitudes related to healthy snacking, fluid intake, PA and sedentary behavior.
- Socioeconomic status: Sociodemographic data were collected, keeping in mind the objectives of the study, including age of parents, ethnicity, education, number of children, profession, family structure and family income.
- Anthropometric measurements: Weight (kg), height (cm) and waist circumference (cm) of the participating children were collected at baseline and will be collected again after intervention.
- Dietary Assessment: Dietary intake: Diet including main meals and snacking patterns was assessed using a validated, modified version of the ToyBox Food Frequency Questionnaire (FFQ) administered by a research assistant. The FFQ was translated in Urdu and back translated to English. A generic food photograph atlas was used to assist participants in estimating portion sizes. Fluid Intake: Was assessed using a modified version of ToyBox Food frequency questionnaire administered by a research assistant. The FFQ was translated in Urdu and back translated to English. A generic food photograph atlas was used to assist participants in identifying portion sizes.
- Physical activity: The physical activity of preschoolers was evaluated using the Pre-PAQ Physical Activity Questionnaire. Pre-PAQ is a three-day activity questionnaire used to assess a child's habitual level of physical activity and sedentary behavior at home. This questionnaire was translated to Urdu and back translated into English.
- Sedentary behavior (including screens and quiet play): Was assessed by 3 questions in the primary care giver questionnaire. These questions assess the number of hours spent on screens and quiet play during weekdays and weekends.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quasi experimental study | Other | Behavioral: Lifestyle ManagementThis 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ManagementLifestyle Management including special focus on healthy water and beverage intake, snacks and dietary practices, minimizing screen time and increasing physical activity. | Behavioural | quasi experimental study |
Primary outcome
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 37623197Reeves 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.
- Background: PubMed 25047374Manios 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.
- Background: PubMed 25584423Brown 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.
- Background: PubMed 22117626Mushtaq 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.
- Background: PubMed 32523724Almas 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.
- Background: PubMed 25241606Gungor NK. Overweight and obesity in children and adolescents. J Clin Res Pediatr Endocrinol. 2014 Sep;6(3):129-43. doi: 10.4274/Jcrpe.1471.
- Background: PubMed 34012766Dogra 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.
- Background: PubMed 32370795Lambrinou 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.
- 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 integrLink provided by the sponsor.
- Individual participant dataSharing planned: No. To keep confidentiality of data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sukaina NA SHABBIR, PhD Candidate principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Management in people with Childhood Obesity, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: January 2026-April 2026 (4 months)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07521579, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.