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

Sponsor

Karabuk University (Other)

Overall Status

Completed

CT.gov ID

NCT04459130

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity Child Obesity	Behavioral: Child Obesity Program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

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.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 (Participant)

Masking Description:

participants do not know they are in the experimental or control group

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 20, 2019

Actual Primary Completion Date :

Mar 20, 2020

Actual Study Completion Date :

Jan 20, 2021

Arms and Interventions

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 - 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	Behavioral: Child Obesity Program 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.
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 - 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

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 - 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

Behavioral: Child Obesity Program

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.

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 - 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

Outcome Measures

Primary Outcome Measures

BKI, [through study completion, an average of 1 year]
Up to 1 year BKI reduction expected at the end of the program
Subcutaneous adipose tissue [through study completion, an average of 1 year]
Up to 1 year BKI reduction expected at the end of the program

Secondary Outcome Measures

number of steps [through study completion, an average of 1 year]
An increase is expected at the end of the follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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