Growth AlterationNCT06514924
Secular Change of Height in Turkish Young Adults
An observational study of Growth Alteration and Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Current Turkish growth reference charts based on anthropometric measurements of individuals with high socioeconomic status in Istanbul in 1989-2002 (TK2002) had shown an increase of mean adult height (1.4 and 2.7 cm in males and females) compared with 1978. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Growth Alteration, Obesity
- What is being tested?
- height and weight measurement
- How many people
- 465 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jun 2024
- 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 18 to 26 years
- All sexes
- Adult
Study population: The study population consists of young adults aged 18 to 26 years who are current students at Istanbul University, representing a diverse demographic background from various regions of Turkey. A total of 465 participants were included in the study, with 217 females and 248 males. The participants were randomly selected from a pool of 65,000 students, ensuring a representative sample of the university's diverse student body. This selection process aimed to capture a wide range of socioeconomic statuses and geographical origins, reflective of the overall Turkish population.
Who may be able to join
- Age:
- Participants must be between 18 and 26 years old.
- Student Status:
- Participants must be current students at Istanbul University.
- Voluntary Participation:
- Participants must voluntarily agree to participate in the study and provide informed, written consent.
Who cannot join
- Chronic Disease:
- Participants with a diagnosis of any chronic disease are excluded.
- History of Surgery Affecting Growth:
- Participants with a history of any surgery that could affect linear growth are excluded.
- Growth Retardation:
- Participants with a diagnosis of growth retardation are excluded.
Show all 14Show fewer
- Growth Hormone Administration:
- Participants who have received growth hormone treatment are excluded.
- Parental Origin:
- Participants with a parent born outside of Turkey are excluded.
- Birth Height or Weight:
- Participants with a birth height or weight less than -2 standard deviations (SDS) are excluded.
- Current Height or BMI:
- Participants with a current height or BMI less than -3 SDS or greater than +3 SDS are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Young Turkish Adults Show a Continuing Positive Secular Change of Height But a Worrying Increase of Overweight in Males
Current Turkish growth reference charts based on anthropometric measurements of individuals with high socioeconomic status in Istanbul in 1989-2002 (TK2002) had shown an increase of mean adult height (1.4 and 2.7 cm in males and females) compared with 1978. Given recent improvements in nutrition, hygiene and access to preventive health services, it is hypothesized that this positive secular trend may continue. A prior power analysis (95% power) showed that at least 122 subjects of each sex were needed to detect a 1.8 cm height increase (p=0.05) vs TK2002. In 2023-2024 a sample of Turkish young adults (18-26 years) was randomly selected from 65,000 students at Istanbul University, originating from every region of Turkey (TK2024). Height, weight, and socioeconomic status (SES, categorized into four groups) were recorded and body mass index (BMI) was calculated. Adult height and BMI were compared with TK2002 and with young adults of Turkish origin living in the Netherlands measured in 2009 (NL2009).
Read the detailed description
Study setting A sample of students was randomly selected from 65,000 students at Istanbul University, originating from every region of Turkey in 2023-2024 (TK2024). The inclusion criteria for the study were: (I) age between 18 and 26 years, (II) being a student at Istanbul University, and (III) volunteering to participate in the study. The exclusion criteria were: (I) diagnosis of a chronic disease, (II) a history of surgery that can affect linear growth, (III) diagnosis of growth retardation, (IV) a history of growth hormone administration, (V) having a parent born outside of Turkey, (VI) birth height or weight less than -2 SDS, and (VII) current height or BMI less than -3 SDS or greater than +3 SDS. This study was approved by the Local Ethical Committee of Istanbul Faculty of Medicine and funded by the Scientific Research Projects Coordination Unit of Istanbul University. Voluntary, informed, written consent was obtained from all the participants. The students' medical history, birthplace, high school graduation province, parental education level and occupation and household income were recorded through a questionnaire.
Measurements Standing height was measured with bare feet using a portable stadiometer and documented to the nearest 0.1 cm. Weight was determined in light clothing using a digital scale and recorded to the closest 0.1 kg. Two trained technicians performed all measurements. Height measurements were repeated twice, and the mean value was calculated. If the difference exceeded 0.3 cm, a third measurement was taken, and the average of the two closest values was used. Body mass index (BMI) was calculated as weight (kg) divided by height (m) square .
Classification of socioeconomic status After collecting all the data, the participants were classified into four groups according to socioeconomic status (SES): SES-1 to 4. SES was determined based on the criteria used in previous national growth studies, which were modified to better align with current conditions. This classification is determined by the educational level of both parents and the father's occupation. Meeting all three criteria was necessary for inclusion in the upper levels of the SES. If any of these criteria are not met, individuals were assigned to a lower SES level.
In the present study, the SES assessment questionnaire is derived from the TK2002 questionnaire, with a single modification: the educational level of parents has been increased by one level. This update is based on data from the Turkish Statistical Institute, which reported a 26% average increase in the duration of education in Turkey between 2008 and 2022.
Comparative Analyses To demonstrate the secular trend, a comparison was made between the data from the present study and the data from the 18-year-old age group in the TK2002 study, which served as the basis for the current national growth curves. The data for 18-year-olds in TK2002 were collected from measurements of senior high school students in six affluent districts of Istanbul. In line with the methodology of the present study, TK2002 also categorized participants into four SES groups based on an SES questionnaire.
The technical specifications and measurement methods of the instruments used in this study are identical to those used in TK2002, ensuring comparability and consistency across both studies.
Adult height and BMI were also compared with TK2002 and with young adults of Turkish origin living in the Netherlands measured in 2009 (NL2009). Age, SES, and geographical region were used to conduct subgroup analyses. Age groups were divided into 18-22 and 23-26 years. Separate subgroups were formed for the seven regions of Turkey based on birthplace or high school graduation.
- Conditions
- Growth Alteration, Obesity
- Being tested
- height and weight measurement
- Keywords
- height, obesity, growth
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
height and weight measurementOther
Also called filling out the socioeconomic status survey
Height and weight measurements and socioeconomic status survey
| Study group | Role | What they receive |
|---|---|---|
| young Turkish males | Aged between 18 - 26 years old Istanbul University students Gender: Male Receives: Other: height and weight measurement | |
| young Turkish females | Aged between 18 - 26 years old Istanbul University students Gender: Female Receives: Other: height and weight measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Adult Height (cm)
Mean height difference in centimeters between the cohorts (Objective: To compare the mean adult height of young Turkish adults in 2023-2024 (TK2024) with those in 2002 (TK2002) and young adults of Turkish origin living in the Netherlands in 2009 (NL2009))
Measured: 01.09.2023- 01.05.2024
Change in Body Mass Index (BMI, kg/m²)
Mean BMI difference and percentage of participants classified as overweight or obese between the cohorts (Objective: To compare the BMI of young Turkish adults in 2023-2024 (TK2024) with those in 2002 (TK2002) and young adults of Turkish origin living in the Netherlands in 2009 (NL2009)) (BMI was calculated as weight (kg) divided by height (m²), with weight measured using a digital scale (SECA 813, Hamburg, Germany).)
Measured: 01.09.2023- 01.05.2024
Secondary outcomes (4)
Association between Height and Socioeconomic Status (SES)
Comparison of mean height across different SES groups
Measured: 01.05.2024-01.07.2024
Association between BMI and Socioeconomic Status (SES)
Comparison of mean BMI across different SES groups
Measured: 01.05.2024-01.07.2024
Regional Differences in Height
Mean height differences across regions
Measured: 01.05.2024- 01.07.2024
Regional Differences in BMI
Mean BMI differences across regions ()
Measured: 01.05.2024 - 01.07.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Sep 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth AlterationStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- 465 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Bayrak Demirel, Istanbul University
- Investigators
- Asli Derya Kardelen Al, MD, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514924
- Sponsor's protocol ID
- ITFPEDENDO1
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Turkish Adults Show a Continuing Positive Secular Change of Height But a Worrying Increase of Overweight in Males
- ClinicalTrials.gov ID
- NCT06514924
- Acronym / sponsor ID
- ITFPEDENDO1
- Conditions
- Growth Alteration, Obesity
- Keywords
- height, obesity, growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 23 Jul 2024 (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.
Current Turkish growth reference charts based on anthropometric measurements of individuals with high socioeconomic status in Istanbul in 1989-2002 (TK2002) had shown an increase of mean adult height (1.4 and 2.7 cm in males and females) compared with 1978. Given recent improvements in nutrition, hygiene and access to preventive health services, it is hypothesized that this positive secular trend may continue. A prior power analysis (95% power) showed that at least 122 subjects of each sex were needed to detect a 1.8 cm height increase (p=0.05) vs TK2002. In 2023-2024 a sample of Turkish young adults (18-26 years) was randomly selected from 65,000 students at Istanbul University, originating from every region of Turkey (TK2024). Height, weight, and socioeconomic status (SES, categorized into four groups) were recorded and body mass index (BMI) was calculated. Adult height and BMI were compared with TK2002 and with young adults of Turkish origin living in the Netherlands measured in 2009 (NL2009).
Detailed description
Study setting A sample of students was randomly selected from 65,000 students at Istanbul University, originating from every region of Turkey in 2023-2024 (TK2024). The inclusion criteria for the study were: (I) age between 18 and 26 years, (II) being a student at Istanbul University, and (III) volunteering to participate in the study. The exclusion criteria were: (I) diagnosis of a chronic disease, (II) a history of surgery that can affect linear growth, (III) diagnosis of growth retardation, (IV) a history of growth hormone administration, (V) having a parent born outside of Turkey, (VI) birth height or weight less than -2 SDS, and (VII) current height or BMI less than -3 SDS or greater than +3 SDS. This study was approved by the Local Ethical Committee of Istanbul Faculty of Medicine and funded by the Scientific Research Projects Coordination Unit of Istanbul University. Voluntary, informed, written consent was obtained from all the participants. The students' medical history, birthplace, high school graduation province, parental education level and occupation and household income were recorded through a questionnaire.
Measurements Standing height was measured with bare feet using a portable stadiometer and documented to the nearest 0.1 cm. Weight was determined in light clothing using a digital scale and recorded to the closest 0.1 kg. Two trained technicians performed all measurements. Height measurements were repeated twice, and the mean value was calculated. If the difference exceeded 0.3 cm, a third measurement was taken, and the average of the two closest values was used. Body mass index (BMI) was calculated as weight (kg) divided by height (m) square .
Classification of socioeconomic status After collecting all the data, the participants were classified into four groups according to socioeconomic status (SES): SES-1 to 4. SES was determined based on the criteria used in previous national growth studies, which were modified to better align with current conditions. This classification is determined by the educational level of both parents and the father's occupation. Meeting all three criteria was necessary for inclusion in the upper levels of the SES. If any of these criteria are not met, individuals were assigned to a lower SES level.
In the present study, the SES assessment questionnaire is derived from the TK2002 questionnaire, with a single modification: the educational level of parents has been increased by one level. This update is based on data from the Turkish Statistical Institute, which reported a 26% average increase in the duration of education in Turkey between 2008 and 2022.
Comparative Analyses To demonstrate the secular trend, a comparison was made between the data from the present study and the data from the 18-year-old age group in the TK2002 study, which served as the basis for the current national growth curves. The data for 18-year-olds in TK2002 were collected from measurements of senior high school students in six affluent districts of Istanbul. In line with the methodology of the present study, TK2002 also categorized participants into four SES groups based on an SES questionnaire.
The technical specifications and measurement methods of the instruments used in this study are identical to those used in TK2002, ensuring comparability and consistency across both studies.
Adult height and BMI were also compared with TK2002 and with young adults of Turkish origin living in the Netherlands measured in 2009 (NL2009). Age, SES, and geographical region were used to conduct subgroup analyses. Age groups were divided into 18-22 and 23-26 years. Separate subgroups were formed for the seven regions of Turkey based on birthplace or high school graduation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young Turkish males | – | Other: height and weight measurementAged between 18 - 26 years old Istanbul University students Gender: Male |
| young Turkish females | – | Other: height and weight measurementAged between 18 - 26 years old Istanbul University students Gender: Female |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study population consists of young adults aged 18 to 26 years who are current students at Istanbul University, representing a diverse demographic background from various regions of Turkey. A total of 465 participants were included in the study, with 217 females and 248 males. The participants were randomly selected from a pool of 65,000 students, ensuring a representative sample of the university's diverse student body. This selection process aimed to capture a wide range of socioeconomic statuses and geographical origins, reflective of the overall Turkish population.
Key inclusion criteria (6 listed)
- Participants must be between 18 and 26 years old.
- Participants must be current students at Istanbul University.
- Participants must voluntarily agree to participate in the study and provide informed, written consent.
Key exclusion criteria (14 listed)
- Participants with a diagnosis of any chronic disease are excluded.
- Participants with a history of any surgery that could affect linear growth are excluded.
- Participants with a diagnosis of growth retardation are excluded.
- Participants who have received growth hormone treatment are excluded.
- Participants with a parent born outside of Turkey are excluded.
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 |
|---|---|---|
| height and weight measurementAlso: filling out the socioeconomic status surveyHeight and weight measurements and socioeconomic status survey | Other | young Turkish females, young Turkish males |
Primary outcome
Change in Mean Adult Height (cm)
Time frame: 01.09.2023- 01.05.2024
Mean height difference in centimeters between the cohorts (Objective: To compare the mean adult height of young Turkish adults in 2023-2024 (TK2024) with those in 2002 (TK2002) and young adults of Turkish origin living in the Netherlands in 2009 (NL2009))
Change in Body Mass Index (BMI, kg/m²)
Time frame: 01.09.2023- 01.05.2024
Mean BMI difference and percentage of participants classified as overweight or obese between the cohorts (Objective: To compare the BMI of young Turkish adults in 2023-2024 (TK2024) with those in 2002 (TK2002) and young adults of Turkish origin living in the Netherlands in 2009 (NL2009)) (BMI was calculated as weight (kg) divided by height (m²), with weight measured using a digital scale (SECA 813, Hamburg, Germany).)
4 secondary outcomes
Association between Height and Socioeconomic Status (SES)
Time frame: 01.05.2024-01.07.2024
Association between BMI and Socioeconomic Status (SES)
Time frame: 01.05.2024-01.07.2024
Regional Differences in Height
Time frame: 01.05.2024- 01.07.2024
Regional Differences in BMI
Time frame: 01.05.2024 - 01.07.2024
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 23 Jul 2024.
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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.
Asli Derya Kardelen Al, MD study chair
Istanbul 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 Growth Alteration and Obesity, run by Istanbul 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 6 inclusion and 14 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 23 Jul 2024. 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?
Change in Mean Adult Height (cm) (time frame: 01.09.2023- 01.05.2024). The study lists 2 primary outcomes in all. 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 23 Jul 2024.