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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mehmet Burak Uyaroglu, PT, MSC contact

+905396545352

mburakuyaroglu@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul Saglik Bilimleri Universty

    Istanbul, 34010

    Recruiting

Other trials in Turkey (Türkiye)

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.

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.

  1. Blood pressure

    Systolic and Diastolic pressures are measured with a sphygmomanometer

    Measured: baseline

  2. Blood pressure

    Systolic and Diastolic pressures are measured with a sphygmomanometer

    Measured: After 5 minutes from baseline

  3. Blood pressure

    Systolic and Diastolic pressures are measured with a sphygmomanometer

    Measured: After 10 minutes from baseline

  4. Subcutaneous fat tissue

    Subcutaneous fat tissue is measured with a caliper in three regions (Biceps, Triceps, and abdomen)

    Measured: baseline

  5. Waist and Hip circumference

    waist and hip circumference is measured with a tape measure

    Measured: baseline

  6. Body weight

    body weight is measured with a scale

    Measured: baseline

Secondary outcomes (6)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted29 Nov 2022
  2. Study start30 Nov 2022
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

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
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

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.

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