- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459130
Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Karabük, Turkey, 78600
- Karabuk University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Child Obesity Program
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
Follow-ups will be performed in the 6th and 9th months after the intervention |
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
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NO_INTERVENTION: Control Grup
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
Follow-ups will be performed in the 6th and 9th months after the intervention |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BKI,
Time Frame: through study completion, an average of 1 year
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Up to 1 year BKI reduction expected at the end of the program
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through study completion, an average of 1 year
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|
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
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of steps
Time Frame: through study completion, an average of 1 year
|
An increase is expected at the end of the follow-up.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
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 (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-196
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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