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NCT Number: NCT06546644

A Structured School-based Health Intervention for the Obesity Prevention

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.

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Key information

Conditions

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

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City School Nawab shah

Nawabshah, Sindh, 67450, Pakistan

Location contact

Faryal Rizwan, Mphil

CONTACT

03147938202

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured school-based intervention

Behavioral

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.

Primary outcomes

  1. Dietary knowledge

    Time frame: 6-months from baseline

    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

  2. Physical activity education

    Time frame: 6-months from baseline

    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.

Secondary outcomes

  1. Health-related quality of life

    Time frame: 6-months from baseline

    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.

  2. Body mass index (BMI)

    Time frame: 6-months from baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

MUHAMMAD ARSHED

CONTACT

[email protected]

03337474464

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • University of Lahore

Registry information

Official study title

Effect of a Structured School-based Health Intervention for Obesity Prevention In Children Aged 5-12 Years

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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