Clinical trial NCT06546644: A Structured School-based Health Intervention for the Obesity Prevention
Official title: Effect of a Structured School-based Health Intervention for Obesity Prevention In Children Aged 5-12 Years
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Obesity
Child Behavior
Obesity, Childhood
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: University of Lahore
First posted: 2024-08-09
Enrollment: 1200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants after baseline measures, will be randomly assigned into two groups intervention and control in a parallel way.
Primary purpose: PREVENTION

Brief summary: The proposed research aims to assess how well a structured intervention is intended to reduce childhood obesity. The intervention addresses food and physical activity behaviors, important determinants of obesity, by concentrating on these elements. The goal of nutritional and physical education is to raise knowledge about the negative effects of obesity and encourage healthy eating habits in children and their caregivers. These educational campaigns will be delivered primarily through schools, guaranteeing a wide audience and consistent messaging.

Detailed description: The demographic profile of Pakistan offers a unique background for researching the dynamics of childhood obesity because of its rapid urban growth and socioeconomic shifts. Processed foods are displacing traditional diets, and children's physical activity is decreasing as a result of longer screen times and restricted access to leisure centers.

The proposed research aims to assess how well a structured intervention is intended to reduce childhood obesity. The intervention addresses food and physical activity behaviors, important determinants of obesity, by concentrating on these elements. Dietary Education: Teaches kids about eating the right portions of food and maintaining a balanced diet. Better eating habits and an understanding of nutrition are among the results.

Information regarding Physical Activity: Raises awareness and encourages regular exercise. Improved comprehension and engagement in physical activities are among the results.

Extra Physical Activity Time: Offers extra opportunities for physical activity after school, such as fitness classes and sports, after hours. Improved fitness, a decrease in sedentary time, and higher levels of physical activity are the results.

Eligibility criteria: Inclusion Criteria:

* Children of age between 5 to 12 years.
* Enrollment at one of the selected schools.

Exclusion Criteria:

* Children and their parents who did not give assent and consent to participate in the study.

Primary outcomes:
measure: Dietary knowledge
timeFrame: 6-months from baseline
measure: Physical activity education
timeFrame: 6-months from baseline
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 6-months from baseline
measure: Body mass index (BMI)
timeFrame: 6-months from baseline
Other outcomes:
Locations:
city: Nawab shah
country: Pakistan
facility: City School Nawab shah
state: Sindh
Study officials:
References:
citation: World Health Organisation. (2020, October 19). Noncommunicable diseases: Childhood Overweight and Obesity. Www.who.int. https://www.who.int/news-room/questions-and-answers/item/noncommunicable-diseases-childhood-overweight-and-obesity.
citation: Guidelines on Physical Activity, Sedentary Behaviour and Sleep for Children under 5 Years of Age. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK541170/
citation: Homs C, Berruezo P, Segun G, Estrada L, de Bont J, Riera-Romani J, Carrillo-Alvarez E, Schroder H, Mila R, Gomez SF. Family-based intervention to prevent childhood obesity among school-age children of low socioeconomic status: study protocol of the FIVALIN project. BMC Pediatr. 2021 May 21;21(1):246. doi: 10.1186/s12887-021-02697-x.
citation: Battaglia G, Giustino V, Tabacchi G, Alesi M, Galassi C, Modica C, Palma A, Bellafiore M. Effectiveness of a Physical Education Program on the Motor and Pre-literacy Skills of Preschoolers From the Training-To-Health Project: A Focus on Weight Status. Front Sports Act Living. 2020 Dec 16;2:579421. doi: 10.3389/fspor.2020.579421. eCollection 2020.
citation: L'hôte, E., Hawkins, N., Lead, U., Strategist, S., Levay, K., & Fellow, R. (2021). Prepared for Impact on Urban Health Changing the Childhood Obesity Conversation to Improve Children's Health. https://www.frameworksinstitute.org/wp-content/uploads/2021/04/GSTC-Childhood-obesity-report-032021.pdf
citation: Yuksel HS, Sahin FN, Maksimovic N, Drid P, Bianco A. School-Based Intervention Programs for Preventing Obesity and Promoting Physical Activity and Fitness: A Systematic Review. Int J Environ Res Public Health. 2020 Jan 3;17(1):347. doi: 10.3390/ijerph17010347.