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Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years

Primary Purpose

Childhood Obesity, Child Obesity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Child Obesity Program
Sponsored by
Karabuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring childhood obesity, school based, obesity intervention

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karabuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Child Obesity Program

Control Grup

Arm 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

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

Outcomes

Primary Outcome Measures

BKI,
Up to 1 year BKI reduction expected at the end of the program
Subcutaneous adipose tissue
Up to 1 year BKI reduction expected at the end of the program

Secondary Outcome Measures

number of steps
An increase is expected at the end of the follow-up.

Full Information

First Posted
June 26, 2020
Last Updated
November 20, 2021
Sponsor
Karabuk University
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1. Study Identification

Unique Protocol Identification Number
NCT04459130
Brief Title
Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years
Official Title
Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karabuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Child Obesity
Keywords
childhood obesity, school based, obesity intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
participants do not know they are in the experimental or control group
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child Obesity Program
Arm Type
Experimental
Arm 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 Title
Control Grup
Arm Type
No Intervention
Arm 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(s)
Child Obesity Program
Intervention 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.
Primary Outcome Measure Information:
Title
BKI,
Description
Up to 1 year BKI reduction expected at the end of the program
Time Frame
through study completion, an average of 1 year
Title
Subcutaneous adipose tissue
Description
Up to 1 year BKI reduction expected at the end of the program
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
number of steps
Description
An increase is expected at the end of the follow-up.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Karabuk University
City
Karabük
ZIP/Postal Code
78600
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years

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