Overweight ChildrenNCT06671964
The Impact of School-Based Intervention for 9-13-year-old School Children with Overweight and Obesity
A study testing Anthropometric measurements, Questionnaire and Educational sessions in people with Overweight Children and Obese Children and Adolescents, run by United Arab Emirates University at 1 site in United Arab Emirates.
Trial summary
Childhood obesity is a major issue for the United Arab Emirates (UAE). Interventions modifying people's nutritional behavior and changing their dietary habits can potentially address this problem. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight Children, Obese Children and Adolescents
- What is being tested?
- Anthropometric measurements, Questionnaire and Educational sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 27 Aug 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
United Arab Emarites University
Al Ain City, Ain
About this study
Official title: 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
Childhood obesity is a major issue for the United Arab Emirates (UAE). Interventions modifying people's nutritional behavior and changing their dietary habits can potentially address this problem. This study assessed the effectiveness of the 6-month school-based nutritional educational intervention on fruit and vegetable intake, nutrition knowledge, anthropometric measures, and practice, attitude, and self-efficacy measures.
Read the detailed description
The problem of childhood obesity is a critical issue for the UAE. Findings of recent studies illustrate that nutritional interventions seeking to modify people's nutritional behavior and change their dietary habits have the potential to address this problem. This article reports the results of the study that was dedicated to the influence of the school-based nutritional educational intervention on fruit and vegetable intake, anthropometric measures, practice, attitude, self-efficacy, and knowledge scores of schoolchildren. The intervention was carried out among 9-13-year-old schoolchildren at public schools from Dubai and Sharjah (n=403). The sample included three groups, including the control group (n=114), Intervention Group 1 (n=148), and Intervention Group 2 (n=141). The control group was exposed to a conventional curriculum on healthy nutrition. Group 1 participated in the intervention involving children, and Group 2 participated in the intervention involving students, peers, and parents.
- Being tested
- Anthropometric measurements, Questionnaire, Educational sessions
- Keywords
- Overnutrition, Nutrition Disorders, Body Weight, Overweight, SchoolChildren, peer pressure
- Medical subject headings
- Overnutrition, Nutrition Disorders, Body Weight, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthropometric measurementsOther
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
QuestionnaireOther
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
Educational sessionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| students one-one | Other | 1. During the intervention, 30-minute in person sessions and lectures are held on a one-on-one basis .
2. Lectures were conducted daily for five days during the first month of the intervention
3. The students were exposed to the school nutrition education curriculum, which may also be considered an intervention as it introduced students to new nutrition knowledge. The school nutrition education curriculum presented general information about nutrition in accordance with official guidelines issued by the UAE Ministry of Education. Topics covered included the dangers of obesity, the prevalence of obesity in the UAE, and potentially effective ways to prevent this problem, the information in this program was broad and did not provide practical recommendations to students except for a set of general suggestions.
4. The topics covered included a healthy eating lifestyle, energy balance, food portion control, healthy snacking, the importance of physical activity and healthy eating, dietary Receives: Other: Anthropometric measurements; Other: Questionnaire; Other: Educational sessions |
| Peers | Other | 1. 30-minute in person sessions were introduced to all the school children, and 10-minute question-and-answer sections were held at the end of each lesson to support knowledge acquisition.
2. Lectures were conducted daily for five days in the first month of the study.
3. The students were exposed to the school nutrition education curriculum, which may also be considered an intervention as it introduced students to new nutrition knowledge. The school nutrition education curriculum presented general information about nutrition in accordance with official guidelines issued by the UAE Ministry of Education. Topics covered included the dangers of obesity, the prevalence of obesity in the UAE, and potentially effective ways to prevent this problem, the information in this program was broad and did not provide practical recommendations to students except for a set of general suggestions.
4. The topics covered included a healthy eating lifestyle, Receives: Other: Educational sessions |
| Control group | No intervention | 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. |
| parents | Other | 1. 30-minute in person sessions and 10-minute question-and-answer sections were held at the end of each lesson to support knowledge acquisition.
2. Lectures were conducted daily for five days in the first month of the study. Receives: Other: Educational sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition Knowledge and Self-Efficacy
- 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
Measured: 6 months
Nutrition Knowledge and Self-Efficacy
- 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
Measured: 6 months
Secondary outcomes (4)
Anthropometric Data
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.
Measured: 6 months
Anthropometric Data
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.
Measured: 6 months
Anthropometric Data
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.
Measured: 6 months
Anthropometric Data
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start27 Aug 2021
- Primary completion19 Mar 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight ChildrenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Educational sessions 2. Anthropometric measurements 3. Questionnaire
- Masking
- None (open label)
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Zuarub, United Arab Emirates University
- Investigators
- Habiba Ali, Study director, UAEUESE Research Office, Study chair, Emarites School Establishment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671964
- Sponsor's protocol ID
- ERSC_2022_744
- Status last verified
- Nov 2024
- First submitted
- 29 Aug 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwalla N, Chehade L, O'Neill LM, Kharroubi S, Kassis A, Cheikh Ismail L, Al Dhaheri AS, Ali HI, Ibrahim S, Chokor FAZ, Mohamad MN, Ayesh W, Nasreddine L, Naja F. Total Usual Nutrient Intakes and Nutritional Status of United Arab Emirates Children (4 Years-12.9 Years): Findings from the Kids Nutrition and Health Survey (KNHS) 2021. Nutrients. 2023 Jan 2;15(1):234. doi: 10.3390/nu15010234.
PubMed 36615891
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06671964
- Acronym / sponsor ID
- ERSC_2022_744
- Keywords
- Overnutrition, Nutrition Disorders, Body Weight, Overweight, SchoolChildren, peer pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 19 Mar 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 4 Nov 2024 (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.
Childhood obesity is a major issue for the United Arab Emirates (UAE). Interventions modifying people's nutritional behavior and changing their dietary habits can potentially address this problem. This study assessed the effectiveness of the 6-month school-based nutritional educational intervention on fruit and vegetable intake, nutrition knowledge, anthropometric measures, and practice, attitude, and self-efficacy measures.
Detailed description
The problem of childhood obesity is a critical issue for the UAE. Findings of recent studies illustrate that nutritional interventions seeking to modify people's nutritional behavior and change their dietary habits have the potential to address this problem. This article reports the results of the study that was dedicated to the influence of the school-based nutritional educational intervention on fruit and vegetable intake, anthropometric measures, practice, attitude, self-efficacy, and knowledge scores of schoolchildren. The intervention was carried out among 9-13-year-old schoolchildren at public schools from Dubai and Sharjah (n=403). The sample included three groups, including the control group (n=114), Intervention Group 1 (n=148), and Intervention Group 2 (n=141). The control group was exposed to a conventional curriculum on healthy nutrition. Group 1 participated in the intervention involving children, and Group 2 participated in the intervention involving students, peers, and parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 1. Educational sessions 2. Anthropometric measurements 3. Questionnaire
| Arm | Type | Receives |
|---|---|---|
| students one-one | Other | Other: Anthropometric measurements, Other: Questionnaire, Other: Educational sessions1. During the intervention, 30-minute in person sessions and lectures are held on a one-on-one basis . 2. Lectures were conducted daily for five days during the first month of the intervention 3. The students were exposed to the school nutrition education curriculum, which may also be considered an intervention as it introduced students to new nutrition knowledge. The school nutrition education curriculum presented general information about nutrition in accordance with official guidelines issued by the UAE Ministry of Education. Topics covered included the dangers of obesity, the prevalence of obesity in the UAE, and potentially effective ways to prevent this problem, the information in this program was broad and did not provide practical recommendations to students except for a set of general suggestions. 4. The topics covered included a healthy eating lifestyle, energy balance, food portion control, healthy snacking, the importance of physical activity and healthy eating, dietary |
| Peers | Other | Other: Educational sessions1. 30-minute in person sessions were introduced to all the school children, and 10-minute question-and-answer sections were held at the end of each lesson to support knowledge acquisition. 2. Lectures were conducted daily for five days in the first month of the study. 3. The students were exposed to the school nutrition education curriculum, which may also be considered an intervention as it introduced students to new nutrition knowledge. The school nutrition education curriculum presented general information about nutrition in accordance with official guidelines issued by the UAE Ministry of Education. Topics covered included the dangers of obesity, the prevalence of obesity in the UAE, and potentially effective ways to prevent this problem, the information in this program was broad and did not provide practical recommendations to students except for a set of general suggestions. 4. The topics covered included a healthy eating lifestyle, |
| Control group | No intervention | –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. |
| parents | Other | Other: Educational sessions1. 30-minute in person sessions and 10-minute question-and-answer sections were held at the end of each lesson to support knowledge acquisition. 2. Lectures were conducted daily for five days in the first month of the study. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Anthropometric measurementsAnthropometric 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 | Other | students one-one |
| QuestionnaireThe 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 | Other | students one-one |
| Educational sessionsThe 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, parents, students one-one |
Primary outcome
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
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
4 secondary outcomes
Anthropometric Data
Time frame: 6 months
Anthropometric Data
Time frame: 6 months
Anthropometric Data
Time frame: 6 months
Anthropometric Data
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 36615891Hwalla N, Chehade L, O'Neill LM, Kharroubi S, Kassis A, Cheikh Ismail L, Al Dhaheri AS, Ali HI, Ibrahim S, Chokor FAZ, Mohamad MN, Ayesh W, Nasreddine L, Naja F. Total Usual Nutrient Intakes and Nutritional Status of United Arab Emirates Children (4 Years-12.9 Years): Findings from the Kids Nutrition and Health Survey (KNHS) 2021. Nutrients. 2023 Jan 2;15(1):234. doi: 10.3390/nu15010234.
- Individual participant dataSharing planned: No
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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.
Habiba Ali study director
UAEU
ESE Research Office study chair
Emarites School Establishment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anthropometric measurements, Questionnaire and Educational sessions in people with Overweight Children and Obese Children and Adolescents, run by United Arab Emirates University at 1 site in United Arab Emirates.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 4 Nov 2024. 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 United Arab Emirates. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nutrition Knowledge and Self-Efficacy (time frame: 6 months). The study lists 2 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 NCT06671964, which also lists 1 linked publication.
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 4 Nov 2024.