- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06671964
The Impact of School-Based Intervention for 9-13-year-old School Children with Overweight and Obesity
The Impact of School-Based Intervention for 9-13-year-old School Children with Overweight and Obesity: Nutrition Knowledge, Attitudes, Self-Efficacy, Fruit and Vegetable Intake, and Anthropometry
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ain
-
Al Ain, Ain, United Arab Emirates
- United Arab Emarites University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- WHO BMI-for-age growth charts, Students with BMI from the 85th to the 95th percentile were categorized as "overweight," and those who were above the 95th percentile were categorized as "obese"
- Attending Government school.
- Within Grades 6-9.
- Live in Dubai or Sharjah
- Female and male students
Exclusion Criteria:
- Students with BMI below the 85th percentile for the WHO BMI-for-age growth charts.
- Not attending a government school
- Living in another emirate (not Dubai or Sharjah)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: students one-one
|
Anthropometric measurements of the students, including weight, height, muscle mass, fat quantity, and waist circumference, were measured.
The WHO BMI charts were utilized for classification.
Stratified Random selection
The collection of data was performed using the "Atlas questionnaire" (Al-Hazzaa et al., 2011) and "nutrition knowledge and healthy lifestyle behavior" questionnaire (Kalender et al., 2011) with additional questions related to self-efficacy and dietary practices adapted from the literature (Becher, 2009; Voss et al., 2017; Kowalski et al., 2004).
Stratified Random selection
The topics that covered included a healthy eating lifestyle, energy balance, food portion control, healthy snacking, the importance of physical activity and healthy eating, dietary practices, and nutrition-related self-efficacy.
|
|
Other: Peers
|
The topics that covered included a healthy eating lifestyle, energy balance, food portion control, healthy snacking, the importance of physical activity and healthy eating, dietary practices, and nutrition-related self-efficacy.
|
|
No Intervention: Control group
The students in the control group did not receive any nutrition intervention except for the usual school curriculum-based nutrition education program.
Participants in the intervention and control groups were recruited from different sections of the same schools.
|
|
|
Other: parents
|
The topics that covered included a healthy eating lifestyle, energy balance, food portion control, healthy snacking, the importance of physical activity and healthy eating, dietary practices, and nutrition-related self-efficacy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutrition Knowledge and Self-Efficacy
Time Frame: 6 months
|
- Change in students' knowledge and self-efficacy scores from baseline values in overweight and obese UAE students aged 9-13 using a validated questionnaire(Arab Teens Lifestyle Questionnaire). The statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) software, and the IBM, USA computer software (version 29). Likert scales, were expressed as weighted mean ± SD. An independent t-test (parametric test) was used to analyze the effect of 2-level qualitative variables on quantitative variables, and one way ANOVA (parametric test) was used to analyze the effect of >2-level qualitative variables on quantitative variables in each questionnaire section |
6 months
|
|
Nutrition Knowledge and Self-Efficacy
Time Frame: 6 months
|
- Change in the percentage of children consuming at least five servings of fruits and vegetables and using a validated questionnaire(Arab Teens Lifestyle Questionnaire). The statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) software, and the IBM, USA computer software (version 29). Likert scales, were expressed as weighted mean ± SD. An independent t-test (parametric test) was used to analyze the effect of 2-level qualitative variables on quantitative variables, and one way ANOVA (parametric test) was used to analyze the effect of >2-level qualitative variables on quantitative variables in each questionnaire section |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric Data
Time Frame: 6 months
|
Change in body measurements(Weight in kilogram, BMI in kg/m^2) The statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) software, and the IBM, USA computer software (version 29).The anthropometric measurements of the control and intervention groups were compared using ANOVA before and after the nutritional education intervention.
|
6 months
|
|
Anthropometric Data
Time Frame: 6 months
|
Change in body measurements(waist circumference in cm) The statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) software, and the IBM, USA computer software (version 29).The anthropometric measurements of the control and intervention groups were compared using ANOVA before and after the nutritional education intervention.
|
6 months
|
|
Anthropometric Data
Time Frame: 6 months
|
Change in body measurements( Muscle Mass in kilogram) The statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) software, and the IBM, USA computer software (version 29).The anthropometric measurements of the control and intervention groups were compared using ANOVA before and after the nutritional education intervention.
|
6 months
|
|
Anthropometric Data
Time Frame: 6 months
|
Change in body measurements( Body Fat percentage using using Tanita BC730W) The statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) software, and the IBM, USA computer software (version 29).The anthropometric measurements of the control and intervention groups were compared using ANOVA before and after the nutritional education intervention.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Habiba Ali, UAEU
- Study Chair: ESE Research Office, Emarites School Establishment
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERSC_2022_744
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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