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Not yet recruitingNCT06546644Updated Aug 9, 2024

A Structured School-based Health Intervention for the Obesity Prevention

An interventional study of Structured school-based intervention in Child Obesity, Child Behavior and Obesity, Childhood, sponsored by Universiti Putra Malaysia. Not yet recruiting at 1 site in Pakistan. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Child Obesity
  • Child Behavior
  • Obesity, Childhood
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Universiti Putra Malaysia is the lead sponsor of 144 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Children and their parents who did not give assent and consent to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    Intervention group

    The children in the intervention group will receive a school-based structured health intervention to prevent obesity in children aged 5-12 years. A pre-tested validated structured school-based intervention is developed for children in the intervention group. The intervention included behavior change regarding dietary patterns and physical activity. Education will be provided to children in lectures, PowerPoint, smart handouts, and videos. The parents will also be involved in this educational stream through seminars and parent schools specially organized events.

    Behavioral: Structured school-based intervention

  • No intervention
    Control

    The children in the control group will receive no intervention.

Interventions

  • BehavioralStructured school-based intervention

    A pre-tested validated structured school-based intervention is developed for children in the intervention group. The intervention included behavior change regarding dietary patterns and physical activity. Education will be provided to children in lectures, PowerPoint, smart handouts, and videos. The parents will also be involved in this educational stream through seminars and parent schools specially organized events.

06

What researchers measure

Primary outcomes

  1. Dietary knowledge

    Dietary knowledge will be measured by 24-hour dietary recall questionnaire Healthy Eating Index (HEI): Scores range from 0 to 100, with higher scores indicating better diet quality. Below 51: Poor diet. 51-80: Needs improvement. Above 80: Good diet

    Time frame: 6-months from baseline

  2. Physical activity education

    Physical activity education will be measured by Global physical activity questionnaire(WHO) Total Physical Activity (MET-minutes): The intensity of activities is expressed in Metabolic Equivalent of Task (MET) minutes. MET values are: Vigorous-intensity activity: 8.0 METs. Moderate-intensity activity: 4.0 METs. Walking: 4.0 METs. Low Activity: \< 600 MET-minutes/week Moderate Activity: 600-2999 MET-minutes/week High Activity: ≥ 3000 MET-minutes/week Sedentary Behavior: More than 8 hours/day of sitting may indicate high sedentary behavior.

    Time frame: 6-months from baseline

Secondary outcomes

  1. Health-related quality of life

    Health-related quality of life will be measured by kids screen questionnaire. 10 items Scoring: Each item is scored on a 5-point Likert scale, summed and transformed into T-scores. Higher scores indicate better overall quality of life. T-scores below 40 typically indicate lower quality of life and potential areas of concern. T-scores between 40 and 60 are considered within the average range. T-scores above 60 indicate higher than average quality of life.

    Time frame: 6-months from baseline

  2. Body mass index (BMI)

    Body mass index (BMI) will be measured by BMI calculator

    Time frame: 6-months from baseline

07

Study locations

1 site
  • City School Nawab shah
    Nawab shah, Sindh 67450, Pakistan
    • Faryal Rizwan, Mphil · Contact · 03147938202
08

References and documents

Publications

  • 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.
  • 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/ PubMed 31091057 ↗
  • 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. PubMed 34020614 ↗
  • 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. PubMed 33367276 ↗
  • 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
  • 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. PubMed 31947891 ↗

Individual participant data

Plan to share: No — The study protocol, statistical plan, and results will be disseminated by publications

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06546644
Lead sponsor
Universiti Putra Malaysia
Collaborators
University of Lahore
Responsible party
Arshed Muhammad (PhD, Universiti Putra Malaysia) — Principal investigator
First posted
Aug 9, 2024
Start date
Aug 15, 2024 (estimated)
Primary completion
Apr 15, 2025 (estimated)
Completion
Apr 15, 2025 (estimated)
Last update
Aug 9, 2024

Study contacts

MUHAMMAD ARSHED
Contact
drarshedchaudhary@gmail.com
03337474464

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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