NutritionNCT05001256
Determination of Physical Activity Status and Adherence to the Mediterranean Diet in Adults and Related Health Outcomes
An observational study of Nutrition and Physical Activity, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
A physically active life with adequate and balanced nutrition is essential for a healthy life. Unhealthy diet and being physically inactive are among the common risk factors that need to be corrected in order to maintain and improve health. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nutrition, Physical Activity, Chronic Disease
- What is being tested?
- questionnaire study
- How many people
- 380 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to 10 Sep 2021
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Individuals between the ages of 18-65 who applied to the physical therapy and rehabilitation outpatient clinic of a private hospital and voluntarily agreed to participate in the study will be included in the study.
Who may be able to join
- be between the ages of 18-65 having applied to the physical therapy outpatient clinic voluntarily agree to participate in research
Who cannot join
- be under the age of 18 be over 65
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Şehitkamil, Gazi̇antep, 27060
About this study
A physically active life with adequate and balanced nutrition is essential for a healthy life. Unhealthy diet and being physically inactive are among the common risk factors that need to be corrected in order to maintain and improve health. The Mediterranean diet, first described by Angel Keys, is rich in plant foods such as grains, fruits, vegetables, legumes, oilseeds and olives; The main source of added oils is olive oil; moderate-high consumption of fish and seafood, moderate-level consumption of eggs, poultry and dairy products, and low-level red meat; It is a nutrition model with moderate intake of wine / fermented beverages (such as turnip, grape juice). Preferring vegetable oils instead of animal fats, preferring fish instead of red meat consumption, preferring low-fat / fat-free milk and dairy products, limiting the intake of simple sugar and refined carbohydrates, fruit rich in fiber and antioxidants in the Mediterranean diet, which is shown as an example of healthy nutrition today. It is thought that this type of nutrition can prevent the formation of chronic diseases due to features such as increasing vegetable consumption.
Determining the nutritional status and physical activity levels of individuals and their associated health outcomes; It is very important in terms of determining the current situation and determining the priority problems that need to be solved.
Read the detailed description
A physically active life with adequate and balanced nutrition is essential for a healthy life. Unhealthy diet and being physically inactive are among the common risk factors that need to be corrected in order to maintain and improve health. In a cohort study of seven countries (USA, Finland, the Netherlands, Italy, the former Yugoslavia, Greece, and Japan) based on 25 years of follow-up and examining the relationship between dietary behaviors and mortality due to coronary heart disease, lower cardiovascular mortality rates were observed among participating countries in the Mediterranean region. . This has been attributed to traditional dietary behaviors such as high olive oil consumption in Greece, high fish consumption in Dalmatia (Croatia) and high vegetable consumption in Italy. Preferring vegetable oils instead of animal fats, preferring fish instead of red meat consumption, preferring low-fat/fat-free milk and dairy products, limiting simple sugar and refined carbohydrate intake, fruit rich in fiber and antioxidants in the Mediterranean diet, which is shown as an example of healthy nutrition today. It is thought that this type of nutrition can prevent the formation of chronic diseases due to the features such as increasing vegetable consumption. It is reported that low physical activity levels increase the risk of chronic diseases. Studies have shown that adherence to the Mediterranean diet is associated with lower BMI, total fat, and abdominal adiposity. It is also known that a decrease in body total fat rate is observed with physical activity. In addition, BMI values decrease with physical activity. With the changes in lifestyle habits in recent years, societies are moving away from the Mediterranean type of diet and becoming more and more sedentary. For this reason, it is very important to determine the current situation regarding the health outcomes related to the nutritional status and physical activity levels of the individuals, to determine the priority problems that need to be solved, and to raise the awareness of the society on this issue.
The aim of this study is to determine the adherence to the Mediterranean diet, physical activity status and related health outcomes of adult individuals who applied to the physical therapy outpatient clinic of a private hospital.
- Conditions
- Nutrition, Physical Activity, Chronic Disease, Obesity, Mediterranean Diet
- Being tested
- questionnaire study
- Keywords
- mediterranean diet, physical activity, obesity, chronic diseases
- Medical subject headings
- Motor Activity, Chronic Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire studyOther
Participants will be surveyed through face-to-face interviews.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Individuals between the ages of 18-65 who applied to the physical therapy and rehabilitation outpatient clinic of a private hospital and voluntarily agreed to participate in the study will be included in the study. Written consent will be obtained from the participants.
Participants' information will be recorded on a pre-prepared questionnaire containing structured questions. Questionnaire questioning will be applied to individuals through face-to-face interviews. The questionnaire form consists of three parts: 1. Sociodemographic characteristics, 2. Mediterranean Diet Adherence Scale (MEDAS), 3. International Physical Activity Questionnaire (IPAQ). Receives: Other: questionnaire study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediterranean Diet Compliance Scale (MEDAS)
The 14-item Mediterranean Diet Adaptation Scale (MEDAS) will be used to determine the adaptation status of individuals to the Mediterranean diet. In the scale of adaptation to the Mediterranean diet, there are a total of 14 questions, 12 of which are about food consumption frequency and 2 are about food consumption habits. The score given for each question is 0 or 1 point. Then the scores are summed and the score is evaluated as ≤5 (low agreement), 6-9 (moderate agreement) and ≥10 (high agreement).
Measured: at baseline
International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) will be used to examine physical activity status. According to the IPAQ form, in which daily activities are evaluated as sitting, walking, moderate and vigorous activities and questioning the activity status in the past week, individuals are grouped as inactive (<600met), minimally active (600-3000met) and active (>3000met) according to their IPAQ scores.
Measured: at baseline
obesity
Body mass index will be calculated by taking the person's height and body weight information.
Waist and hip circumference measurements will also be made.
Measured: at baseline
chronic disease
79 / 5000 Çeviri sonuçları Participants will be asked about the presence of a chronic disease diagnosed by the physician.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start15 Jul 2021
- Primary completion30 Aug 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezihe Otay Lule, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001256
- Sponsor's protocol ID
- notaylule
- Status last verified
- Oct 2021
- First submitted
- 5 Aug 2021
- Last updated
- 20 Oct 2021
- 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 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Physical Activity Status and Adherence to the Mediterranean Diet in Adults and Related Health Outcomes
- ClinicalTrials.gov ID
- NCT05001256
- Acronym / sponsor ID
- notaylule
- Conditions
- Nutrition, Physical Activity, Chronic Disease, Obesity, Mediterranean Diet
- Keywords
- mediterranean diet, physical activity, obesity, chronic diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 11 Aug 2021 (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.
A physically active life with adequate and balanced nutrition is essential for a healthy life. Unhealthy diet and being physically inactive are among the common risk factors that need to be corrected in order to maintain and improve health. The Mediterranean diet, first described by Angel Keys, is rich in plant foods such as grains, fruits, vegetables, legumes, oilseeds and olives; The main source of added oils is olive oil; moderate-high consumption of fish and seafood, moderate-level consumption of eggs, poultry and dairy products, and low-level red meat; It is a nutrition model with moderate intake of wine / fermented beverages (such as turnip, grape juice). Preferring vegetable oils instead of animal fats, preferring fish instead of red meat consumption, preferring low-fat / fat-free milk and dairy products, limiting the intake of simple sugar and refined carbohydrates, fruit rich in fiber and antioxidants in the Mediterranean diet, which is shown as an example of healthy nutrition today. It is thought that this type of nutrition can prevent the formation of chronic diseases due to features such as increasing vegetable consumption.
Determining the nutritional status and physical activity levels of individuals and their associated health outcomes; It is very important in terms of determining the current situation and determining the priority problems that need to be solved.
Detailed description
A physically active life with adequate and balanced nutrition is essential for a healthy life. Unhealthy diet and being physically inactive are among the common risk factors that need to be corrected in order to maintain and improve health. In a cohort study of seven countries (USA, Finland, the Netherlands, Italy, the former Yugoslavia, Greece, and Japan) based on 25 years of follow-up and examining the relationship between dietary behaviors and mortality due to coronary heart disease, lower cardiovascular mortality rates were observed among participating countries in the Mediterranean region. . This has been attributed to traditional dietary behaviors such as high olive oil consumption in Greece, high fish consumption in Dalmatia (Croatia) and high vegetable consumption in Italy. Preferring vegetable oils instead of animal fats, preferring fish instead of red meat consumption, preferring low-fat/fat-free milk and dairy products, limiting simple sugar and refined carbohydrate intake, fruit rich in fiber and antioxidants in the Mediterranean diet, which is shown as an example of healthy nutrition today. It is thought that this type of nutrition can prevent the formation of chronic diseases due to the features such as increasing vegetable consumption. It is reported that low physical activity levels increase the risk of chronic diseases. Studies have shown that adherence to the Mediterranean diet is associated with lower BMI, total fat, and abdominal adiposity. It is also known that a decrease in body total fat rate is observed with physical activity. In addition, BMI values decrease with physical activity. With the changes in lifestyle habits in recent years, societies are moving away from the Mediterranean type of diet and becoming more and more sedentary. For this reason, it is very important to determine the current situation regarding the health outcomes related to the nutritional status and physical activity levels of the individuals, to determine the priority problems that need to be solved, and to raise the awareness of the society on this issue.
The aim of this study is to determine the adherence to the Mediterranean diet, physical activity status and related health outcomes of adult individuals who applied to the physical therapy outpatient clinic of a private hospital.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: questionnaire studyIndividuals between the ages of 18-65 who applied to the physical therapy and rehabilitation outpatient clinic of a private hospital and voluntarily agreed to participate in the study will be included in the study. Written consent will be obtained from the participants. Participants' information will be recorded on a pre-prepared questionnaire containing structured questions. Questionnaire questioning will be applied to individuals through face-to-face interviews. The questionnaire form consists of three parts: 1. Sociodemographic characteristics, 2. Mediterranean Diet Adherence Scale (MEDAS), 3. International Physical Activity Questionnaire (IPAQ). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals between the ages of 18-65 who applied to the physical therapy and rehabilitation outpatient clinic of a private hospital and voluntarily agreed to participate in the study will be included in the study.
Key inclusion criteria (1 listed)
- be between the ages of 18-65 having applied to the physical therapy outpatient clinic voluntarily agree to participate in research
Key exclusion criteria (1 listed)
- be under the age of 18 be over 65
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 |
|---|---|---|
| questionnaire studyParticipants will be surveyed through face-to-face interviews. | Other | All Participants |
Primary outcome
Mediterranean Diet Compliance Scale (MEDAS)
Time frame: at baseline
The 14-item Mediterranean Diet Adaptation Scale (MEDAS) will be used to determine the adaptation status of individuals to the Mediterranean diet. In the scale of adaptation to the Mediterranean diet, there are a total of 14 questions, 12 of which are about food consumption frequency and 2 are about food consumption habits. The score given for each question is 0 or 1 point. Then the scores are summed and the score is evaluated as ≤5 (low agreement), 6-9 (moderate agreement) and ≥10 (high agreement).
International Physical Activity Questionnaire (IPAQ)
Time frame: at baseline
The International Physical Activity Questionnaire (IPAQ) will be used to examine physical activity status. According to the IPAQ form, in which daily activities are evaluated as sitting, walking, moderate and vigorous activities and questioning the activity status in the past week, individuals are grouped as inactive (<600met), minimally active (600-3000met) and active (>3000met) according to their IPAQ scores.
obesity
Time frame: at baseline
Body mass index will be calculated by taking the person's height and body weight information. Waist and hip circumference measurements will also be made.
chronic disease
Time frame: at baseline
79 / 5000 Çeviri sonuçları Participants will be asked about the presence of a chronic disease diagnosed by the physician.
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 20 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Nutrition
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nutrition and Physical Activity, run by University of Gaziantep 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 1 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 20 Oct 2021. 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?
Mediterranean Diet Compliance Scale (MEDAS) (time frame: at baseline). The study lists 4 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 20 Oct 2021.