Overweight and ObesityNCT05470556
Investigation of Peak Expiratory Flow and Physically Fitness in Obese and Overweight Adolescents
An observational study of Overweight and Obesity, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2022to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Peak Expiratory Flow, Physical Activity Level, Anthropometric Measurements, and Core Performance in Obese and Overweight Adolescents
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.
Read the detailed description
Due to the increasing prevalence of childhood obesity and overweight, health problems may begin to appear at an early age. Overweight and obese people are at risk for medical conditions that can lead to greater morbidity and mortality. Lack of physical activity is a well-known risk factor for obesity and the relationship between them has been supported by many studies. It has also been reported by studies that obesity affects respiratory parameters. In overweight and obese adolescents, a relationship is likely between the affected respiratory parameters and the weakened core region. There are not enough studies on this subject in the literature. Therefore, the aim of the study is to examine the physical activity level, core performance, anthropometric measurements and peak expiratory flow in overweight and obese adolescents in comparison with normal weight adolescents.
- Conditions
- Overweight and Obesity
- Keywords
- peak expiratory flow, core muscle strength, physical activity
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Secondary outcomes (4)
Core Muscle Strength
A modified push-up and sit-up test will be used to evaluate the strength of the core muscles. Measurements will be made using a stopwatch and the number of repetitions in 30 seconds will be recorded.
Measured: baseline
Child Physical Activity Questionnaire
Only 9 of the 10 items that make up the scale are used to calculate activity scores. Evaluates the activities done for 7 days. It consists of 5 stages of scoring. 1 indicates the lowest, 5 the highest level of physical activity. The average of the total score indicates the summary score. A higher score indicates a higher level of physical activity.
Measured: baseline
Neck circumference
Neck circumference will be measured from the lower border of the laryngeal protrusion with a tape measure.
Measured: baseline
Waist circumference
Waist circumference will be measured with a tape measure in the standing position, by determining the midpoint between the lowest rib and the iliac crest from the exposed waist circumference.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start30 Jun 2022
- Primary completion15 Oct 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket AKINCI, PT, PhD, Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470556
- Sponsor's protocol ID
- 2022/70-09
- Status last verified
- Nov 2022
- First submitted
- 24 Jun 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Peak Expiratory Flow, Physical Activity Level, Anthropometric Measurements, and Core Performance in Obese and Overweight Adolescents
- ClinicalTrials.gov ID
- NCT05470556
- Acronym / sponsor ID
- 2022/70-09
- Conditions
- Overweight and Obesity
- Keywords
- peak expiratory flow, core muscle strength, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Due to the increasing prevalence of childhood obesity and overweight, health problems may begin to appear at an early age. Overweight and obese people are at risk for medical conditions that can lead to greater morbidity and mortality. Lack of physical activity is a well-known risk factor for obesity and the relationship between them has been supported by many studies. It has also been reported by studies that obesity affects respiratory parameters. In overweight and obese adolescents, a relationship is likely between the affected respiratory parameters and the weakened core region. There are not enough studies on this subject in the literature. Therefore, the aim of the study is to examine the physical activity level, core performance, anthropometric measurements and peak expiratory flow in overweight and obese adolescents in comparison with normal weight adolescents.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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.) |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak Expiratory Flow (PEF)
Time frame: baseline
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).
4 secondary outcomes
Core Muscle Strength
Time frame: baseline
Child Physical Activity Questionnaire
Time frame: baseline
Neck circumference
Time frame: baseline
Waist circumference
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buket AKINCI, PT, PhD study chair
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Expiratory Flow (PEF) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.