Health, SubjectiveNCT05629351
Prevalence of Sedentary Lifestyle, Pre-hypertension, and Obesity
An observational study of Health, Subjective and Healthy, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Hypertension has been a serious problem among people from different ages in the last few decades, so by taking this in consideration we decided to search for specific risk factors that cause hypertension in young healthy adults, and to achieve that we are looking for pre-hypertension, obesity, and sedentary lifestyle… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective, Healthy
- What is being tested?
- Observational Group
- Type of treatment
- Injection or infusion
- How many people
- 382 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2022to 30 Nov 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Health young adult Subjects whose age between 18 to 25, female and male, and are willing to volunteer to this research
Who may be able to join
- Volunteer subjects
Who cannot join
- Smoker Subjects
- Alcohol drinker Subjects
- Subjects who use drugs that affect blood pressure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Saglik Bilimleri Universty
Istanbul, 34010
About this study
Official title: Prevalence of Sedentary Lifestyle, Pre-hypertension, and Obesity Among Healthy Young Adults
Hypertension has been a serious problem among people from different ages in the last few decades, so by taking this in consideration we decided to search for specific risk factors that cause hypertension in young healthy adults, and to achieve that we are looking for pre-hypertension, obesity, and sedentary lifestyle among this group by using different scale tools and questionnaires.
Read the detailed description
Hypertension has been a serious issue worldwide and there is a wide variety of content in literature regarding its risks, treatment modalities, and disease course. In this study, it was aimed to investigate the "pre-hypertension" state, which is the pre-step of hypertension, and to find its risk in young adults. While screening literature we found the incidence of pre-hypertension to be between 17% and 49% in individuals aged 18-30 years. However, study methods have generally been limited to blood pressure and anthropometric measurements. In our study, a holistic research will be carried out with different scales and questionnaires by enriching the method part.
The aim of this study is to determine the incidence of prehypertension, sedentary life and obesity in healthy young adults aged 18-25, and then to determine the relationship between these risk factors. 382 young adults will be included in this study. Blood pressure will be measured with a sphygmomanometer, subcutaneous fat tissue with a caliper, height with a height measurement device, waist and hip circumference with a tape measure, and body weight with a scale, BMI (body mass index) and double product will be recorded according to the data received by doing specific calculations. Participant's physical activity status will be evaluated with the International Physical Activity Scale and Leisure Activity Scale, dietary habits with the Dutch Eating Habits Questionnaire, sleep status with the Pittsburg Sleep Quality Questionnaire, and psychosocial status with the Perceived Stress Scale and Beck Depression Scale.
- Conditions
- Health, Subjective, Healthy
- Being tested
- Observational Group
- Keywords
- pre-hypertension, sedentary lifestyle, obesity, risk factors
- Medical subject headings
- Prehypertension, Sedentary Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational GroupOther
Demographic Data (Blood pressure, subcutaneous fat tissue, height, waist and hip circumference, and body weight, BMI (body mass index) and double product)
International Physical Activity Questionnaire (IPAQ)
Godin-Shephard Leisure-Time Physical Activity Questionnaire
The Dutch Eating Behavior Questionnaire
Pittsburg Sleep Quality Questionnaire
Perceived Stress Scale and Beck Depression Scale
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic and Diastolic pressures are measured with a sphygmomanometer
Measured: baseline
Blood pressure
Systolic and Diastolic pressures are measured with a sphygmomanometer
Measured: After 5 minutes from baseline
Blood pressure
Systolic and Diastolic pressures are measured with a sphygmomanometer
Measured: After 10 minutes from baseline
Subcutaneous fat tissue
Subcutaneous fat tissue is measured with a caliper in three regions (Biceps, Triceps, and abdomen)
Measured: baseline
Waist and Hip circumference
waist and hip circumference is measured with a tape measure
Measured: baseline
Body weight
body weight is measured with a scale
Measured: baseline
Secondary outcomes (6)
International Physical Activity Questionnaire (IPAQ)
he International Physical Activity Questionnaire (IPAQ) was developed to address these concerns by a group of experts in 1998 to facilitate surveillance of physical activity based on a global standard. The IPAQ has since become the most widely used physical activity questionnaire, with two versions available: the 31 item long form (IPAQ-LF) and the 9 item short form (IPAQ-SF). The short form records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.
Measured: baseline
Dutch Eating Behavior Questionnaire (DEBQ)
The Dutch Eating Behavior Questionnaire (DEBQ), developed by van Strien et al., simultaneously measures all three types of overeating proposed in these theories. It consists of 33 items covering the domains emotional eating (13 items), external eating (10 items), and restraint (10 items). All items are answered on a 5-point Likert scale ranging from 1('never') to 5 ('very often'). The Dutch original version of the DEBQ has been found to have good psychometric properties regarding reliability, factor structure and predictive validity.
Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.Cronbach alpha coefficients were above the recommended cut-off values of 0.80 for adequate consistency , whereas the test-retest reliability remains good.
Measured: baseline
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GLTEQ)
The GLTEQ measures the frequency of strenuous, moderate, and mild leisure-time physical activity performed for periods of 15 min or more over a usual week. Recently, a new scoring method has been proposed for generating an overall GLTEQ score that aligns with current recommendations for physical activity and the dose. The health contribution score (HCS) is based on only strenuous and moderate physical activity and is computed by multiplying the frequencies of strenuous and moderate activities by 9 and 5 metabolic equivalent of task (METs), respectively, and then adding the resultant scores. The HCS ranges between 0 and 98 and is converted into one of three categories, namely, insufficiently active (i.e., score <14 units that is the equivalent of <7 kcal/kg/week), moderately active (i.e., score between 14 and 23 units that is the equivalent of between 7 and 13.9 kcal/kg/week), and active (i.e., score ≥24 units that exceeds 13.9 kcal/kg/week).
Measured: baseline
The Perceived Stress Scale
The Perceived Stress Scale (PSS-10) is a 10-item questionnaire originally developed by Cohen et al. (1983) widely used to assess stress levels in young people and adults aged 12 and above. It evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable and overloading over the previous month.
The questions ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way on a five-point scale from 'never' to 'very often'. Answers are then scored as follow: Never = 0 Almost never = 1 Sometimes = 2 Fairly often = 3 Very often = 4 To calculate a total PSS score, responses to the four positively stated items (items 4, 5, 7 and 8) first need to be reversed (i.e. 0 => 4; 1 => 3; 2 => 2; 3 => 1; 4 => 0).
The PSS score is then obtained by summing across all items. Higher scores indicate higher levels of perceived stress.
Measured: baseline
Beck Depression Inventory II
The Beck Depression Inventory II (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The BDI has been developed in different forms, including several computerized forms, a card form the 13-item short form and the more recent BDI-II by Beck, Steer \& Brown, 1996. The BDI takes approximately 10 minutes to complete, although clients require a fifth - sixth grade reading level to adequately understand the questions. There is a four-point scale for each item ranging from 0 to 3. On two items (16 and 18) there are seven options to indicate either an increase or decrease of appetite and sleep. Cut-off score guidelines for the BDI-II are given with the recommendation that thresholds be adjusted based on the characteristics of the sample, and the purpose for use of the BDI-II. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Measured: baseline
Pittsburg Sleep Quality Questionnaire
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
Scores for each question range from 0 to 3. However PSQI minimum score is 0, maximum Score is 21 . TOTAL point < 5 associated with good sleep quality TOTAL > 5 associated with poor sleep quality.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start30 Nov 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 382 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumaya Shalabi, Istanbul Saglik Bilimleri University
- Investigators
- Esra Pehlivan, ASST. Prof, Principal investigator, Istanbul Saglik Bilimleri UniverstySeyedehatefeh Taghvatalab, Study chair, Istanbul Saglik Bilimleri Universtyİlmiye Aktolgali, Study chair, Istanbul Saglik Bilimleri UniverstyBetul Kuzu, Study chair, Istanbul Saglik Bilimleri Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629351
- Sponsor's protocol ID
- Saglikbilimleriuni
- Status last verified
- Jan 2023
- First submitted
- 11 Nov 2022
- Last updated
- 26 Jan 2023
- 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sedentary Lifestyle, Pre-hypertension, and Obesity Among Healthy Young Adults
- ClinicalTrials.gov ID
- NCT05629351
- Acronym / sponsor ID
- Saglikbilimleriuni
- Conditions
- Health, Subjective, Healthy
- Keywords
- pre-hypertension, sedentary lifestyle, obesity, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 29 Nov 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.
Hypertension has been a serious problem among people from different ages in the last few decades, so by taking this in consideration we decided to search for specific risk factors that cause hypertension in young healthy adults, and to achieve that we are looking for pre-hypertension, obesity, and sedentary lifestyle among this group by using different scale tools and questionnaires.
Detailed description
Hypertension has been a serious issue worldwide and there is a wide variety of content in literature regarding its risks, treatment modalities, and disease course. In this study, it was aimed to investigate the "pre-hypertension" state, which is the pre-step of hypertension, and to find its risk in young adults. While screening literature we found the incidence of pre-hypertension to be between 17% and 49% in individuals aged 18-30 years. However, study methods have generally been limited to blood pressure and anthropometric measurements. In our study, a holistic research will be carried out with different scales and questionnaires by enriching the method part.
The aim of this study is to determine the incidence of prehypertension, sedentary life and obesity in healthy young adults aged 18-25, and then to determine the relationship between these risk factors. 382 young adults will be included in this study. Blood pressure will be measured with a sphygmomanometer, subcutaneous fat tissue with a caliper, height with a height measurement device, waist and hip circumference with a tape measure, and body weight with a scale, BMI (body mass index) and double product will be recorded according to the data received by doing specific calculations. Participant's physical activity status will be evaluated with the International Physical Activity Scale and Leisure Activity Scale, dietary habits with the Dutch Eating Habits Questionnaire, sleep status with the Pittsburg Sleep Quality Questionnaire, and psychosocial status with the Perceived Stress Scale and Beck Depression Scale.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Health young adult Subjects whose age between 18 to 25, female and male, and are willing to volunteer to this research
Key inclusion criteria (1 listed)
- Volunteer subjects
Key exclusion criteria (3 listed)
- Smoker Subjects
- Alcohol drinker Subjects
- Subjects who use drugs that affect blood pressure
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 |
|---|---|---|
| Observational GroupDemographic Data (Blood pressure, subcutaneous fat tissue, height, waist and hip circumference, and body weight, BMI (body mass index) and double product) International Physical Activity Questionnaire (IPAQ) Godin-Shephard Leisure-Time Physical Activity Questionnaire The Dutch Eating Behavior Questionnaire Pittsburg Sleep Quality Questionnaire Perceived Stress Scale and Beck Depression Scale | Other | – |
Primary outcome
Blood pressure
Time frame: baseline
Systolic and Diastolic pressures are measured with a sphygmomanometer
Blood pressure
Time frame: After 5 minutes from baseline
Systolic and Diastolic pressures are measured with a sphygmomanometer
Blood pressure
Time frame: After 10 minutes from baseline
Systolic and Diastolic pressures are measured with a sphygmomanometer
Subcutaneous fat tissue
Time frame: baseline
Subcutaneous fat tissue is measured with a caliper in three regions (Biceps, Triceps, and abdomen)
Waist and Hip circumference
Time frame: baseline
waist and hip circumference is measured with a tape measure
Body weight
Time frame: baseline
body weight is measured with a scale
6 secondary outcomes
International Physical Activity Questionnaire (IPAQ)
Time frame: baseline
Dutch Eating Behavior Questionnaire (DEBQ)
Time frame: baseline
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GLTEQ)
Time frame: baseline
The Perceived Stress Scale
Time frame: baseline
Beck Depression Inventory II
Time frame: baseline
Pittsburg Sleep Quality Questionnaire
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- 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.
Esra Pehlivan, ASST. Prof principal investigator
Istanbul Saglik Bilimleri Universty
Seyedehatefeh Taghvatalab study chair
Istanbul Saglik Bilimleri Universty
İlmiye Aktolgali study chair
Istanbul Saglik Bilimleri Universty
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 Health, Subjective and Healthy, run by Istanbul Saglik Bilimleri 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sumaya Shalabi (+905388559296, sumaya.j.sh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: baseline). The study lists 6 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 26 Jan 2023.