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

NCT04459130 | Completed DMC

• 1 other identifier: 2020-196
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity; Child Obesity

Keywords

childhood obesity; school based; obesity intervention

Outcome Measures

Primary Outcomes (2)

• BKI,

  Up to 1 year BKI reduction expected at the end of the program

  through study completion, an average of 1 year

• 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 Outcomes (1)

• number of steps

  through study completion, an average of 1 year

Study Arms (2)

Child Obesity Program

EXPERIMENTAL

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

Control Grup

NO 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

Interventions

Child Obesity Program BEHAVIORAL

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.

Child Obesity Program

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk University

Karabük, 78600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants do not know they are in the experimental or control group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: November 20, 2019
• Primary Completion: March 20, 2020
• Study Completion: January 20, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)