NCT06170853

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

December 6, 2023

Last Update Submit

May 14, 2026

Conditions

Keywords

Childhood ObesityAdolescentMetabolic ParametersAugmented Reality GlassesAnthropometric Values

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Augmented reality glasses group

EXPERIMENTAL

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.

Other: Exercise with augmented reality glasses

Control group

NO INTERVENTION

No intervention/application will be made to the children who will be included in the control group.

Interventions

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.

Augmented reality glasses group

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Meral Bayat, PhD

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

December 1, 2023

Primary Completion

December 5, 2024

Study Completion

June 1, 2025

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations