<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04459130</url>
  </required_header>
  <id_info>
    <org_study_id>2020-196</org_study_id>
    <nct_id>NCT04459130</nct_id>
  </id_info>
  <brief_title>Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years</brief_title>
  <official_title>Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karabuk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karabuk University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity, which is an important public health problem of the last century globally, affects&#xD;
      not only adults but also children and young people. Reducing childhood obesity requires&#xD;
      effective lifestyle changes and behavioral interventions aimed at healthy nutrition, physical&#xD;
      activity and stress management.&#xD;
&#xD;
      to reduce childhood obesity, including school-based multi-component behavioral research in&#xD;
      Turkey it has not been demonstrated to parents.&#xD;
&#xD;
      The program, which is planned to be carried out and aims to reduce overweight and obesity in&#xD;
      children, is a school-based parenting lifestyle intervention involving multiple behaviors.&#xD;
      The program includes family visits, game-based physical activity activities with children,&#xD;
      healthy eating recommendations and healthy eating activities with parent participation. The&#xD;
      program planned to be implemented was developed to evaluate whether healthy preferences and&#xD;
      lifestyle intervention reduce obesity. The aim of this study is to make the positive health&#xD;
      behaviors permanent in children, to be a guide for combating childhood obesity and to be&#xD;
      useful for future research. to be applied to the research, nutrition consists of 10 sessions,&#xD;
      physical activity, including issues such as coping with healthy ways with stress Child&#xD;
      Obesity Program (COP), it is thought to overcome this deficiency was needed in Turkey.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2019</start_date>
  <completion_date type="Actual">January 20, 2021</completion_date>
  <primary_completion_date type="Actual">March 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>participants do not know they are in the experimental or control group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>BKI,</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Up to 1 year BKI reduction expected at the end of the program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subcutaneous adipose tissue</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Up to 1 year BKI reduction expected at the end of the program</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of steps</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>An increase is expected at the end of the follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Child Obesity</condition>
  <arm_group>
    <arm_group_label>Child Obesity Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
Pretest: BMI, weight average, subcutaneous adipose tissue measurement and application of scales&#xD;
- Children's Dietary Self- Efficacy Scale-CDSS&#xD;
- Food Behavior Scale&#xD;
- Child Heart Health Development Attitude Scale (exercise, stress, nutrition subscales)&#xD;
-Daily Food Consumption Form&#xD;
-Drink Consumption Form&#xD;
Health Perception Form&#xD;
Follow-ups will be performed in the 6th and 9th months after the intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Grup</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.&#xD;
Pretest: BMI, weight average, subcutaneous adipose tissue measurement and application of scales&#xD;
- Children's Dietary Self- Efficacy Scale-CDSS&#xD;
- Food Behavior Scale&#xD;
- Child Heart Health Development Attitude Scale (exercise, stress, nutrition subscales)&#xD;
-Daily Food Consumption Form&#xD;
-Drink Consumption Form&#xD;
Health Perception Form&#xD;
Follow-ups will be performed in the 6th and 9th months after the intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Child Obesity Program</intervention_name>
    <description>The program consists of 10 sessions, each lasting 40 minutes. An EOP booklet containing session programs will be distributed to children.&#xD;
The topics of the sessions are as follows:&#xD;
Session 1: Healthy lifestyles&#xD;
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&#xD;
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&#xD;
Session 10: Together for a healthy life (Melnyk et al., 2006; 2007; 2009). Detailed information about the sessions is given in annex -3.</description>
    <arm_group_label>Child Obesity Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Overweight or obese children aged 8-11&#xD;
&#xD;
          -  Volunteers to participate in the research&#xD;
&#xD;
          -  Students who are allowed to participate in the research by their parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with any physical or mental disability and chronic disease (diabetes,&#xD;
             metabolic syndrome, heart disease… etc)&#xD;
&#xD;
               -  Children who have normal weight&#xD;
&#xD;
               -  Children who constantly use the drug that can affect weight management (weight&#xD;
                  gain and loss) The age group included in the study Piaget's development theory&#xD;
                  coincides with the concrete process period. Concrete&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Karabuk University</name>
      <address>
        <city>Karabük</city>
        <zip>78600</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 20, 2021</last_update_submitted>
  <last_update_submitted_qc>November 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karabuk University</investigator_affiliation>
    <investigator_full_name>nesrin arslan</investigator_full_name>
    <investigator_title>lecturer</investigator_title>
  </responsible_party>
  <keyword>childhood obesity</keyword>
  <keyword>school based</keyword>
  <keyword>obesity intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04459130
org study id: 2020-196
nct id: NCT04459130
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Prevention
masking: Single (Participant)
masking description: participants do not know they are in the experimental or control group
measure: BKI,
time frame: through study completion, an average of 1 year
description: Up to 1 year BKI reduction expected at the end of the program
measure: Subcutaneous adipose tissue
time frame: through study completion, an average of 1 year
description: Up to 1 year BKI reduction expected at the end of the program
measure: number of steps
time frame: through study completion, an average of 1 year
description: An increase is expected at the end of the follow-up.
arm group label: Child Obesity Program
arm group type: Experimental
description: 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
arm group label: Control Grup
arm group type: No Intervention
description: 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
intervention type: Behavioral
intervention name: Child Obesity Program
description: 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.
arm group label: Child Obesity Program
criteria: 
gender: All
minimum age: 8 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Karabuk University
investigator full name: nesrin arslan
investigator title: lecturer
mesh term: Obesity
mesh term: Overweight
mesh term: Pediatric Obesity
sharing ipd: No