- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05629351
Prevalence of Sedentary Lifestyle, Pre-hypertension, and Obesity
Prevalence of Sedentary Lifestyle, Pre-hypertension, and Obesity Among Healthy Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sumaya Shalabi
- Phone Number: +905388559296
- Email: sumaya.j.sh@gmail.com
Study Contact Backup
- Name: Mehmet Burak Uyaroglu, PT, MSC
- Phone Number: +905396545352
- Email: mburakuyaroglu@gmail.com
Study Locations
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Istanbul, Turkey, 34010
- Recruiting
- Istanbul Saglik Bilimleri Universty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Volunteer subjects
Exclusion Criteria:
- Smoker Subjects
- Alcohol drinker Subjects
- Subjects who use drugs that affect blood pressure
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: baseline
|
Systolic and Diastolic pressures are measured with a sphygmomanometer
|
baseline
|
|
Blood pressure
Time Frame: After 5 minutes from baseline
|
Systolic and Diastolic pressures are measured with a sphygmomanometer
|
After 5 minutes from baseline
|
|
Blood pressure
Time Frame: After 10 minutes from baseline
|
Systolic and Diastolic pressures are measured with a sphygmomanometer
|
After 10 minutes from baseline
|
|
Subcutaneous fat tissue
Time Frame: baseline
|
Subcutaneous fat tissue is measured with a caliper in three regions (Biceps, Triceps, and abdomen)
|
baseline
|
|
Waist and Hip circumference
Time Frame: baseline
|
waist and hip circumference is measured with a tape measure
|
baseline
|
|
Body weight
Time Frame: baseline
|
body weight is measured with a scale
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Physical Activity Questionnaire (IPAQ)
Time Frame: baseline
|
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.
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baseline
|
|
Dutch Eating Behavior Questionnaire (DEBQ)
Time Frame: baseline
|
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. |
baseline
|
|
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GLTEQ)
Time Frame: baseline
|
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).
|
baseline
|
|
The Perceived Stress Scale
Time Frame: baseline
|
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. |
baseline
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Beck Depression Inventory II
Time Frame: baseline
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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.
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baseline
|
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Pittsburg Sleep Quality Questionnaire
Time Frame: baseline
|
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. |
baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Esra Pehlivan, ASST. Prof, Istanbul Saglik Bilimleri Universty
- Study Chair: Seyedehatefeh Taghvatalab, Istanbul Saglik Bilimleri Universty
- Study Chair: İlmiye Aktolgali, Istanbul Saglik Bilimleri Universty
- Study Chair: Betul Kuzu, Istanbul Saglik Bilimleri Universty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SaglikBilimleriUni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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