NCT05470556

Brief Summary

Due to the increasing prevalence of childhood obesity and overweight, health problems may begin to appear at an early age. The aim of this study is to examine physical activity level, core performance, anthropometric measurements and peak expiratory flow in overweight and obese adolescents compared to normal weight adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

June 24, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

June 24, 2022

Last Update Submit

November 15, 2022

Conditions

Keywords

peak expiratory flowcore muscle strengthphysical activity

Outcome Measures

Primary Outcomes (1)

  • Peak Expiratory Flow (PEF)

    Peak expiratory flow will be measured with a peak expiratory flow meter. The measurement is taken while the person is standing. After taking a deep breath, exhale as hard and as fast as you can. 3 measurements will be made and the best value will be recorded as peak expiratory flow-PEF (L/min).

    baseline

Secondary Outcomes (4)

  • Core Muscle Strength

    baseline

  • Child Physical Activity Questionnaire

    baseline

  • Neck circumference

    baseline

  • Waist circumference

    baseline

Study Arms (3)

Overweight adolescents

This group will consist of 20 overweight adolescents (Body mass index (BMI) percentile value is 85.-95)

Obese adolescents

This group will consist of 20 obese adolescents (BMI percentile value is above the 95th)

normal weight

This group will consist of 20 normal-weight adolescents (BMI percentile value is 5th-85th.)

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study will consist of 60 volunteer adolescents who are obese, overweight and normal weight studying in the 5th, 6th and 7th grades of secondary school.

You may qualify if:

  • BMI percentile value is 85.-95. between and above the 95th,
  • Do not have any chronic disease,
  • Do not have orthopedic problems that would prevent them from participating in the study,
  • Secondary school students who are willing to participate in the study and whose parents' consent has been obtained will be included.
  • BMI percentile value is 5th-85th. between,
  • Do not have any chronic disease,
  • Having no orthopedic and neurological problems that would prevent them from participating in the study,
  • Secondary school students who are willing to participate in the study and whose parents' consent has been obtained will be included.

You may not qualify if:

  • BMI percentile value below the 5th,
  • With chronic cardiac and pulmonary disease,
  • Having a diagnosis of neurological or other disease affecting cognitive functions,
  • Individuals receiving medical treatment that will affect attention and concentration will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Buket AKINCI, PT, PhD

    Biruni University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

June 24, 2022

First Posted

July 22, 2022

Study Start

June 30, 2022

Primary Completion

October 15, 2022

Study Completion

November 15, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations