The Effect of Exercise With AR Glasses on Metabolic Parameters and Anthropometric Measurements in Obese Adolescents

Childhood Obesity Clinical Trial

Official title:

The Effect of Exercise With AR Glasses on Metabolic Parameters and Anthropometric Measurements in Obese Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170853
• Other study ID #: 2023/198
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2023
• Source: TC Erciyes University
• Contact: Harun Özbey, PhD
• Phone: +905446559461
• Email: harunozbey[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was planned as a randomized controlled experimental study to determine the effect of exercise with Augmented Reality Goggles (AR) on metabolic parameters and anthropometric measurement values in obese children aged 10-19 years. The study will be conducted with children diagnosed with obesity between the ages of 10-19 years who are followed up in the Pediatric Endocrinology Outpatient Clinic of Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital. According to the sample calculation, a total of 20 obese children aged 10-19 years (AR exercise group=10 and control group=10) will be included in the sample of the study. The data of the study will be collected using the Descriptive Characteristics Form for Obese Children and Their Families, Serum and Urine Biochemistry Values Form, Anthropometric Measurement Values Form, Augmented Reality Goggles, Body Composition Analyzer, Caliper, Tape Measure and Digital Height and Weight Measurement Device. Ethics committee permission was obtained from "Erciyes University Clinical Research Ethics Committee" and institutional permission was obtained from ERU Health Practice and Research Center Mustafa Eraslan Fevzi Mercan Children's Hospital. Hypothesis tests, correlation and regression analyzes will be applied according to the suitability of the data for normal distribution. As a result of the study, it is expected that exercise application with AR glasses will improve metabolic parameters and anthropometric measurement values in obese children.

Description:

Obesity, which is one of the major health problems in both developed and developing countries today, is a health problem that occurs with an increase in adipose tissue when energy intake is higher than energy consumption and can cause social, psychological and serious medical problems. If current trends continue, it is reported that 70 million children may be obese and overweight by 2025 and obesity will be a leading health problem. Childhood obesity increases in the first year of life, between 5-6 years of age and during puberty. 1/3 of obese children and 80% of obese adolescents remain obese when they reach adulthood. On the other hand, it is known that 30% of adult obesity cases date back to childhood. It has been reported that obesity affects 10.9-20.0% of all children and adolescents. In a study involving 5206 school-age children (mean age 8.6±1.2 years, 50.2% boys) from seven European countries (Turkey, Bulgaria, Romania, Lithuania, Germany, Italy and the Netherlands), it was reported that the prevalence of obesity in Turkish children was 7.7%, the second highest in Europe after Romania. Obesity in childhood has many medical adverse effects on children. Obesity may cause problems such as rapid growth, early menstruation, increase in blood lipids, increase in heart rate and heart rate volume, fatty liver, impaired sugar metabolism, hypertension, increase in white adipose tissue, increase in serum irisin, myonectin, triglyceride, total cholesterol and leptin levels and decrease in omentin-1 levels. In studies conducted in obese and healthy children, it was found that triglyceride, total cholesterol, irisin, low density lipoprotein (LDL-C) and leptin concentrations were higher in obese children compared to healthy children and omentin-1 levels were lower. Considering that childhood obesity continues into adulthood and brings many problems, the importance of combating obesity in this period is clearly seen. Reducing calorie intake, increasing exercise and providing psychosocial support are very important in the fight against obesity. While exercise constitutes a part of the standard treatment of obesity, it has been reported to be more effective than diet because it increases energy expenditure. In studies conducted in obese children, it was found that planned and long-term moderate exercise increased serum irisin, myonectin, omentin-1 and HDL concentrations and decreased serum leptin, triglyceride, total cholesterol and LDL concentrations. It has also been reported that exercise reduces metabolic and cardiovascular complications and improves body composition, cardiovascular health and mental health. Despite the numerous benefits of exercise, it has been reported that regular exercise habits are low in obese children. It has been reported that obese children cannot exercise regularly due to reasons such as low motivation, parents' inability to spare time to spend time with their children, children who are overwhelmed between courses/courses in the exam marathon with career anxiety, lack of emotional support and inability to give up existing habits. In this direction, exercise that requires continuity in the management of childhood obesity can be made dynamic for obese children by using different approaches. Therefore, it is thought that structured exercise with augmented reality glasses (AR) that can respond to the reactions of the obese child will be more dynamic, improve metabolic and anthropometric values and prevent macrovascular complications that may develop in obese children. This study was planned as a randomized controlled experimental study to determine the effect of exercise with AR glasses on metabolic parameters and anthropometric measurement values in obese children aged 10-19 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

• Those between the ages of 10-19,

• Having been diagnosed with childhood obesity at least six months ago,

• Do not have any other chronic disease,

• No psychiatric diagnosis,

• No orthopedic problems,

• Able to read and write

• Can speak Turkish,

• No mental, physical or neurological disability,

• Residing in the province where the research will be conducted,

• Children and children with parental consent to participate in the study will be included in the study.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Other:
• Exercise with augmented reality glasses
Three days a week (12 weeks in total), each session will be 60 minutes in total, and moderate exercise will be done with AR glasses.

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum leptin levels	Serum leptin of children with type 1 diabetes before, during, after exercise and during the control session.	Change in average serum leptin over 12-week sessions
Primary	Change in serum irisin levels	Serum irisin of children with type 1 diabetes before, during, after exercise and during the control session.	Change in average serum irisin over 12-week sessions
Primary	Change in body mass index	Average body mass index values of children with obesity before, during, after exercise and during the control session.	Change in average body mass index over 12-week sessions