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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04459130
Other study ID # 2020-196
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2019
Est. completion date January 20, 2021

Study information

Verified date November 2021
Source Karabuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date January 20, 2021
Est. primary completion date March 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 11 Years
Eligibility 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 diseaseā€¦ 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 Design


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.

Locations

Country Name City State
Turkey Karabuk University Karabük

Sponsors (1)

Lead Sponsor Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary BKI, Up to 1 year BKI reduction expected at the end of the program through study completion, an average of 1 year
Primary Subcutaneous adipose tissue Up to 1 year BKI reduction expected at the end of the program through study completion, an average of 1 year
Secondary number of steps An increase is expected at the end of the follow-up. through study completion, an average of 1 year
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