Childhood ObesityNCT04459130
Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years
A study testing Child Obesity Program in people with Childhood Obesity and Child Obesity, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Obesity, which is an important public health problem of the last century globally, affects not only adults but also children and young people. Reducing childhood obesity requires effective lifestyle changes and behavioral interventions aimed at healthy nutrition, physical activity and stress management. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Child Obesity
- What is being tested?
- Child Obesity Program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2019to 20 Jan 2021
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Overweight or obese children aged 8-11
- Volunteers to participate in the research
- Students who are allowed to participate in the research by their parents
Who cannot join
- Children with any physical or mental disability and chronic disease (diabetes, metabolic syndrome, heart disease… etc)
- Children who have normal weight
- Children who constantly use the drug that can affect weight management (weight gain and loss) The age group included in the study Piaget's development theory coincides with the concrete process period. Concrete
Trial locations and contacts
1 site in 1 country.
About this study
Obesity, which is an important public health problem of the last century globally, affects not only adults but also children and young people. Reducing childhood obesity requires effective lifestyle changes and behavioral interventions aimed at healthy nutrition, physical activity and stress management.
to reduce childhood obesity, including school-based multi-component behavioral research in Turkey it has not been demonstrated to parents.
The program, which is planned to be carried out and aims to reduce overweight and obesity in children, is a school-based parenting lifestyle intervention involving multiple behaviors. The program includes family visits, game-based physical activity activities with children, healthy eating recommendations and healthy eating activities with parent participation. The program planned to be implemented was developed to evaluate whether healthy preferences and lifestyle intervention reduce obesity. The aim of this study is to make the positive health behaviors permanent in children, to be a guide for combating childhood obesity and to be useful for future research. to be applied to the research, nutrition consists of 10 sessions, physical activity, including issues such as coping with healthy ways with stress Child Obesity Program (COP), it is thought to overcome this deficiency was needed in Turkey.
- Conditions
- Childhood Obesity, Child Obesity
- Being tested
- Child Obesity Program
- Keywords
- childhood obesity, school based, obesity intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child Obesity ProgramBehavioural
The program consists of 10 sessions, each lasting 40 minutes. An EOP booklet containing session programs will be distributed to children.
The topics of the sessions are as follows:
Session 1: Healthy lifestyles
- Session 2: Self-esteem and positive thinking, Setting goals Session 3: Stress and Coping, Coping with Emotions in Healthy Ways Session 4: Personality and effective communication
- Session 5: Activity: Time for action Session 6: Nutrition basics Session 7: Reading tags Session 8: Portion size, nutrition and healthy food choices in schools Session 9: Snacks can also be healthy: Healthy choices
- Session 10: Together for a healthy life (Melnyk et al., 2006; 2007; 2009). Detailed information about the sessions is given in annex -3.
| Study group | Role | What they receive |
|---|---|---|
| Child Obesity Program | Experimental | Firstly, overweight and obese students will be determined by measuring their height and weight. While selecting children for the experimental group, random numbers table will be used. As a result of statistical analysis, 33 students will be selected to the Experiment group. Child Obesity Program (COP) will be applied to students in the experimental group for 10 weeks. Before the program is implemented, children's height, weight, subcutaneous adipose tissue measurements will be made. The pedometer wristband will be distributed.
Pretest: BMI, weight average, subcutaneous adipose tissue measurement and application of scales
* - Children's Dietary Self- Efficacy Scale-CDSS
* - Food Behavior Scale
* - Child Heart Health Development Attitude Scale (exercise, stress, nutrition subscales)
* -Daily Food Consumption Form
* -Drink Consumption Form
* Health Perception Form
Follow-ups will be performed in the 6th and 9th months after the intervention Receives: Behavioral: Child Obesity Program |
| Control Grup | No intervention | Firstly, overweight and obese students will be determined by measuring their height and weight. When selecting children for the control group, random numbers table will be used. As a result of statistical analysis, 33 students will be selected to the Control group. First, children's height, weight, subcutaneous adipose tissue measurements will be made. The pedometer wristband will be distributed. The control group will be trained for a daily healthy diet and physical activity. Pretest: BMI, weight average, subcutaneous adipose tissue measurement and application of scales * - Children's Dietary Self- Efficacy Scale-CDSS * - Food Behavior Scale * - Child Heart Health Development Attitude Scale (exercise, stress, nutrition subscales) * -Daily Food Consumption Form * -Drink Consumption Form * Health Perception Form Follow-ups will be performed in the 6th and 9th months after the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BKI,
Up to 1 year BKI reduction expected at the end of the program
Measured: through study completion, an average of 1 year
Subcutaneous adipose tissue
Up to 1 year BKI reduction expected at the end of the program
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
number of steps
An increase is expected at the end of the follow-up.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start20 Nov 2019
- Primary completion20 Mar 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- Child Obesity Program (COP), The program consists of 10 sessions, each lasting 40 minutes. An EOP booklet containing session programs will be distributed to children.The research was determined as randomized controlled pretest-posttest control group design type.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nesrin arslan, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459130
- Sponsor's protocol ID
- 2020-196
- Status last verified
- Nov 2021
- First submitted
- 26 Jun 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years
- ClinicalTrials.gov ID
- NCT04459130
- Acronym / sponsor ID
- 2020-196
- Conditions
- Childhood Obesity, Child Obesity
- Keywords
- childhood obesity, school based, obesity intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 7 Jul 2020 (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.
Obesity, which is an important public health problem of the last century globally, affects not only adults but also children and young people. Reducing childhood obesity requires effective lifestyle changes and behavioral interventions aimed at healthy nutrition, physical activity and stress management.
to reduce childhood obesity, including school-based multi-component behavioral research in Turkey it has not been demonstrated to parents.
The program, which is planned to be carried out and aims to reduce overweight and obesity in children, is a school-based parenting lifestyle intervention involving multiple behaviors. The program includes family visits, game-based physical activity activities with children, healthy eating recommendations and healthy eating activities with parent participation. The program planned to be implemented was developed to evaluate whether healthy preferences and lifestyle intervention reduce obesity. The aim of this study is to make the positive health behaviors permanent in children, to be a guide for combating childhood obesity and to be useful for future research. to be applied to the research, nutrition consists of 10 sessions, physical activity, including issues such as coping with healthy ways with stress Child Obesity Program (COP), it is thought to overcome this deficiency was needed in Turkey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Child Obesity Program (COP), The program consists of 10 sessions, each lasting 40 minutes. An EOP booklet containing session programs will be distributed to children.The research was determined as randomized controlled pretest-posttest control group design type.
| Arm | Type | Receives |
|---|---|---|
| Child Obesity Program | Experimental | Behavioral: Child Obesity ProgramFirstly, overweight and obese students will be determined by measuring their height and weight. While selecting children for the experimental group, random numbers table will be used. As a result of statistical analysis, 33 students will be selected to the Experiment group. Child Obesity Program (COP) will be applied to students in the experimental group for 10 weeks. Before the program is implemented, children's height, weight, subcutaneous adipose tissue measurements will be made. The pedometer wristband will be distributed. Pretest: BMI, weight average, subcutaneous adipose tissue measurement and application of scales * - Children's Dietary Self- Efficacy Scale-CDSS * - Food Behavior Scale * - Child Heart Health Development Attitude Scale (exercise, stress, nutrition subscales) * -Daily Food Consumption Form * -Drink Consumption Form * Health Perception Form Follow-ups will be performed in the 6th and 9th months after the intervention |
| Control Grup | No intervention | –Firstly, overweight and obese students will be determined by measuring their height and weight. When selecting children for the control group, random numbers table will be used. As a result of statistical analysis, 33 students will be selected to the Control group. First, children's height, weight, subcutaneous adipose tissue measurements will be made. The pedometer wristband will be distributed. The control group will be trained for a daily healthy diet and physical activity. Pretest: BMI, weight average, subcutaneous adipose tissue measurement and application of scales * - Children's Dietary Self- Efficacy Scale-CDSS * - Food Behavior Scale * - Child Heart Health Development Attitude Scale (exercise, stress, nutrition subscales) * -Daily Food Consumption Form * -Drink Consumption Form * Health Perception Form Follow-ups will be performed in the 6th and 9th months after the intervention |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Overweight or obese children aged 8-11
- Volunteers to participate in the research
- Students who are allowed to participate in the research by their parents
Key exclusion criteria (3 listed)
- Children with any physical or mental disability and chronic disease (diabetes, metabolic syndrome, heart disease… etc)
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 |
|---|---|---|
| Child Obesity ProgramThe program consists of 10 sessions, each lasting 40 minutes. An EOP booklet containing session programs will be distributed to children. The topics of the sessions are as follows: Session 1: Healthy lifestyles * Session 2: Self-esteem and positive thinking, Setting goals Session 3: Stress and Coping, Coping with Emotions in Healthy Ways Session 4: Personality and effective communication * Session 5: Activity: Time for action Session 6: Nutrition basics Session 7: Reading tags Session 8: Portion size, nutrition and healthy food choices in schools Session 9: Snacks can also be healthy: Healthy choices * Session 10: Together for a healthy life (Melnyk et al., 2006; 2007; 2009). Detailed information about the sessions is given in annex -3. | Behavioural | Child Obesity Program |
Primary outcome
BKI,
Time frame: through study completion, an average of 1 year
Up to 1 year BKI reduction expected at the end of the program
Subcutaneous adipose tissue
Time frame: through study completion, an average of 1 year
Up to 1 year BKI reduction expected at the end of the program
1 secondary outcome
number of steps
Time frame: through study completion, an average of 1 year
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 3 Dec 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child Obesity Program in people with Childhood Obesity and Child Obesity, run by Karabuk University at 1 site in Turkey (Türkiye).
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 3 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 3 Dec 2021. 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 Turkey (Türkiye). 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?
BKI, (time frame: through study completion, an average of 1 year). 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?
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 3 Dec 2021.