Obesity, ChildhoodNCT04201158
A Comparison of Activities of Daily Living, Physical Fitness and Quality of Life in Obese and Healthy Adolescents
An observational study of Obesity, Childhood and Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
It is known that activities of daily living, physical fitness, exercise capacity and quality of life are affected by the obesity. It is aimed to determine the effects obesity on daily living activities, physical fitness, exercise capacity and quality of life in obese adolescents compared to healthy subjects in this… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Healthy
- What is being tested?
- Exercise Capacity
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2019to 1 Apr 2020
- How long will I take part?
- 1 Day
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 15 obese adolescents, 15 obese adolescent adolescents and 15 healthy female adolescents and 15 healthy male adolescents compatible with age and sex will be recruited from obese adolescents according to the BMI reference system.
Who may be able to join
- Healthy group:
- Being normal weight according to BMI reference system,
- Being between the ages of 10-18 and volunteer to participate in the research,
- Being able to walk and cooperate
- Obese Group:
- Obesity diagnosis according to BMI reference system,
- Being between the ages of 10-18 and volunteer to participate in the research,
- Being able to walk and cooperate.
Who cannot join
- Healthy Group:
- Comorbidities that may affect exercise performance and other physical tests,
- Having cardiovascular problems, musculoskeletal and neurological disease,
- Having cognitive or motor limitation or other chronic diseases.
- Obese Group:
- Having a neurological disease or other clinical diagnosis that may affect cognitive status,
- Having musculoskeletal and neurological diseases, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease that may affect exercise performance,
- Using medication that affects appetite and weight.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Samanpazari, 06100
About this study
It is known that activities of daily living, physical fitness, exercise capacity and quality of life are affected by the obesity. It is aimed to determine the effects obesity on daily living activities, physical fitness, exercise capacity and quality of life in obese adolescents compared to healthy subjects in this study. The relationship between these parameters and the activities of daily living which are less studied in obese adolescents will be evaluated.
Read the detailed description
Obesity among children, adolescents and adults has emerged as one of the most serious public health problems in the 21st century. There has been a significant decrease in the exercise capacity, physical fitness and activities of daily living of children and adolescents with the increase in the prevalence of obesity over the last decade. Obesity can cause not only health problems but also psychological effects. This situation have negative effects on the quality of life. The effect of these parameters on healthy individuals and obese adolescents will be demonstrated by this study and will guide the rehabilitation of obese adolescents.
- Conditions
- Obesity, Childhood, Healthy
- Being tested
- Exercise Capacity
- Keywords
- Physical Fitness, Exercise Capacity, Activities of Daily Living, Quality of Life
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CapacityDiagnostic test
Modified Shuttle Walk Test
| Study group | Role | What they receive |
|---|---|---|
| Obese Group (Girl) | Diagnosed with the obesity according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria.Diagnosed with a neurological disease or another clinical diagnosis that may affect the cognitive state, musculoskeletal and neurological disease, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease, which may affect the performance of exercise and using the drug that affects appetite and weight are the exclusion criteria. Receives: Diagnostic Test: Exercise Capacity | |
| Obese Group (Boy) | Diagnosed with the obesity according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Diagnosed with a neurological disease or another clinical diagnosis that may affect the cognitive state, musculoskeletal and neurological disease, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease, which may affect the performance of exercise and using the drug that affects appetite and weight are the exclusion criteria. Receives: Diagnostic Test: Exercise Capacity | |
| Control Group (Girl) | Being normal weight according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Having comorbidities which may affect exercise performance and other physical tests, diagnosed with the cardiovascular problems, musculoskeletal and neurological diseases, cognitive or motor limitation or other chronic diseases are exclusion criteria. Receives: Diagnostic Test: Exercise Capacity | |
| Control Group (Boy) | Being normal weight according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Having comorbidities which may affect exercise performance and other physical tests, diagnosed with the cardiovascular problems, musculoskeletal and neurological diseases, cognitive or motor limitation or other chronic diseases are exclusion criteria. Receives: Diagnostic Test: Exercise Capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified shuttle walk test.
Maximal exercise capacity
Measured: February 2019-February 2020
Secondary outcomes (6)
Waist circumference, Abdominal circumference, Ratio of waist to hip
Antropometric measurements
Measured: February 2019-February 2020
Hand grip strength by hand dynamometer (Jamar).
Peripheral Muscle Strength
Measured: February 2019-February 2020
the Glittre Activities of Daily Living (ADL) Test.
Activities of daily living
Measured: February 2019-February 2020
the Munich Physical Fitness Test-MFT
Physical Fitness
Measured: February 2019-February 2020
Modified push-ups, shuttles and squats as possible for 30 seconds
Peripheral muscle endurance
Measured: February 2019-February 2020
The Pediatric Outcomes Data Collection Instrument (PODCI)
Quality of Life
Measured: February 2019-February 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start15 Jun 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Ceren Iskenderoglu, Physical Therapist, Study chair, Hacettepe UniversityDeniz Inal Ince, Professor, Study chair, Hacettepe UniversityMelda Saglam, Associate Professor, Study chair, Hacettepe UniversityNaciye Vardar Yagli, Associate Professor, Study chair, Hacettepe UniversityHazal Sonbahar Ulu, MSc, Study chair, Hacettepe UniversityMelis Pehlivanturk Kizilkan, MD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201158
- Sponsor's protocol ID
- GO19/60
- Status last verified
- May 2020
- First submitted
- 13 Dec 2019
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Activities of Daily Living, Physical Fitness and Quality of Life in Obese and Healthy Adolescents
- ClinicalTrials.gov ID
- NCT04201158
- Acronym / sponsor ID
- GO19/60
- Conditions
- Obesity, Childhood, Healthy
- Keywords
- Physical Fitness, Exercise Capacity, Activities of Daily Living, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 17 Dec 2019 (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.
It is known that activities of daily living, physical fitness, exercise capacity and quality of life are affected by the obesity. It is aimed to determine the effects obesity on daily living activities, physical fitness, exercise capacity and quality of life in obese adolescents compared to healthy subjects in this study. The relationship between these parameters and the activities of daily living which are less studied in obese adolescents will be evaluated.
Detailed description
Obesity among children, adolescents and adults has emerged as one of the most serious public health problems in the 21st century. There has been a significant decrease in the exercise capacity, physical fitness and activities of daily living of children and adolescents with the increase in the prevalence of obesity over the last decade. Obesity can cause not only health problems but also psychological effects. This situation have negative effects on the quality of life. The effect of these parameters on healthy individuals and obese adolescents will be demonstrated by this study and will guide the rehabilitation of obese adolescents.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese Group (Girl) | – | Diagnostic Test: Exercise CapacityDiagnosed with the obesity according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria.Diagnosed with a neurological disease or another clinical diagnosis that may affect the cognitive state, musculoskeletal and neurological disease, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease, which may affect the performance of exercise and using the drug that affects appetite and weight are the exclusion criteria. |
| Obese Group (Boy) | – | Diagnostic Test: Exercise CapacityDiagnosed with the obesity according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Diagnosed with a neurological disease or another clinical diagnosis that may affect the cognitive state, musculoskeletal and neurological disease, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease, which may affect the performance of exercise and using the drug that affects appetite and weight are the exclusion criteria. |
| Control Group (Girl) | – | Diagnostic Test: Exercise CapacityBeing normal weight according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Having comorbidities which may affect exercise performance and other physical tests, diagnosed with the cardiovascular problems, musculoskeletal and neurological diseases, cognitive or motor limitation or other chronic diseases are exclusion criteria. |
| Control Group (Boy) | – | Diagnostic Test: Exercise CapacityBeing normal weight according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Having comorbidities which may affect exercise performance and other physical tests, diagnosed with the cardiovascular problems, musculoskeletal and neurological diseases, cognitive or motor limitation or other chronic diseases are exclusion criteria. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 15 obese adolescents, 15 obese adolescent adolescents and 15 healthy female adolescents and 15 healthy male adolescents compatible with age and sex will be recruited from obese adolescents according to the BMI reference system.
Key inclusion criteria (8 listed)
- Being normal weight according to BMI reference system,
- Being between the ages of 10-18 and volunteer to participate in the research,
- Being able to walk and cooperate
- Obesity diagnosis according to BMI reference system,
- Being between the ages of 10-18 and volunteer to participate in the research,
Key exclusion criteria (8 listed)
- Comorbidities that may affect exercise performance and other physical tests,
- Having cardiovascular problems, musculoskeletal and neurological disease,
- Having cognitive or motor limitation or other chronic diseases.
- Having a neurological disease or other clinical diagnosis that may affect cognitive status,
- Having musculoskeletal and neurological diseases, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease that may affect exercise performance,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise CapacityModified Shuttle Walk Test | Diagnostic test | Control Group (Boy), Control Group (Girl), Obese Group (Boy), Obese Group (Girl) |
Primary outcome
The Modified shuttle walk test.
Time frame: February 2019-February 2020
Maximal exercise capacity
6 secondary outcomes
Waist circumference, Abdominal circumference, Ratio of waist to hip
Time frame: February 2019-February 2020
Hand grip strength by hand dynamometer (Jamar).
Time frame: February 2019-February 2020
the Glittre Activities of Daily Living (ADL) Test.
Time frame: February 2019-February 2020
the Munich Physical Fitness Test-MFT
Time frame: February 2019-February 2020
Modified push-ups, shuttles and squats as possible for 30 seconds
Time frame: February 2019-February 2020
The Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: February 2019-February 2020
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 5 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ceren Iskenderoglu, Physical Therapist study chair
Hacettepe University
Deniz Inal Ince, Professor study chair
Hacettepe University
Melda Saglam, Associate Professor study chair
Hacettepe 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 Obesity, Childhood and Healthy, run by Hacettepe 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 8 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 5 May 2020. 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?
The Modified shuttle walk test. (time frame: February 2019-February 2020). 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 5 May 2020.