Child ObesityNCT06546644
A Structured School-based Health Intervention for the Obesity Prevention
A study testing Structured school-based intervention in people with Child Obesity and Child Behavior, run by Universiti Putra Malaysia at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Obesity, Child Behavior, Obesity, Childhood
- What is being tested?
- Structured school-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2024to 15 Apr 2025
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of age between 5 to 12 years.
- Enrollment at one of the selected schools.
Who cannot join
- Children and their parents who did not give assent and consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
City School Nawab shah
Nawabshah, Sindh, 67450
Faryal Rizwan, Mphil, 03147938202
About this study
Official title: Effect of a Structured School-based Health Intervention for Obesity Prevention In Children Aged 5-12 Years
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.
- Conditions
- Child Obesity, Child Behavior, Obesity, Childhood
- Being tested
- Structured school-based intervention
- Medical subject headings
- Pediatric Obesity, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured school-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Structured school-based intervention |
| Control | No intervention | The children in the control group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-months from baseline
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.
Measured: 6-months from baseline
Secondary outcomes (2)
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.
Measured: 6-months from baseline
Body mass index (BMI)
Body mass index (BMI) will be measured by BMI calculator
Measured: 6-months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Child ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants after baseline measures, will be randomly assigned into two groups intervention and control in a parallel way.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546644
- Sponsor's protocol ID
- FAHS
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol, statistical plan, and results will be disseminated by publications
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 31091057Homs 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 34020614Battaglia 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 33367276L'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
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Structured School-based Health Intervention for Obesity Prevention In Children Aged 5-12 Years
- ClinicalTrials.gov ID
- NCT06546644
- Acronym / sponsor ID
- FAHS
- Conditions
- Child Obesity, Child Behavior, Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 9 Aug 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The participants after baseline measures, will be randomly assigned into two groups intervention and control in a parallel way.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Structured school-based interventionThe 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. |
| Control | No intervention | –The children in the control group will receive no intervention. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children of age between 5 to 12 years.
- Enrollment at one of the selected schools.
Key exclusion criteria (1 listed)
- Children and their parents who did not give assent and consent to participate in the study.
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 |
|---|---|---|
| Structured school-based interventionA 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. | Behavioural | Intervention group |
Primary outcome
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
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.
2 secondary outcomes
Health-related quality of life
Time frame: 6-months from baseline
Body mass index (BMI)
Time frame: 6-months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Results publicationWorld 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.
- Results publication: PubMed 31091057Guidelines 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/
- Results publication: PubMed 34020614Homs 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.
- Results publication: PubMed 33367276Battaglia 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.
- Results publicationL'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
- Results publication: PubMed 31947891Yuksel 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.
- Individual participant dataSharing planned: No. The study protocol, statistical plan, and results will be disseminated by publications
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured school-based intervention in people with Child Obesity and Child Behavior, run by Universiti Putra Malaysia at 1 site in Pakistan.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MUHAMMAD ARSHED (03337474464, drarshedchaudhary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary knowledge (time frame: 6-months from baseline). 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 NCT06546644, which also lists 6 linked publications.
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 9 Aug 2024.