HypertensionNCT07106567
Mediterranean Diet And Blood Pressure In Hypertension
A study testing Mediterranean diet education in people with Hypertension and Mediterranean Diet, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
An experimental randomized controlled trial was conducted to evaluate the effects of Mediterranean diet education on blood pressure levels and quality of life in hypertensive patients. The sample size was determined using power analysis (n=70). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension, Mediterranean Diet, Quality of Life
- What is being tested?
- Mediterranean diet education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 22 Jul 2024
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Being between 18 and 60 years of age
- Being willing and able to participate in the study
- Being diagnosed with primary hypertension at least 6 months ago
- Being in the inactive group according to the International Physical Activity Questionnaire
- Having a score of 35 or below on the Perceived Stress Scale
- Being literate.
Who cannot join
- - Having changed their eating habits in the last year
- If the patient is a woman, they are pregnant
- Having been diagnosed with an eating disorder
- Having been diagnosed with a psychiatric diagnosis and/or receiving psychological support
- Being on antidepressants and/or steroids
- Being on any diet/receiving dietitian support
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- Having been diagnosed with heart failure, chronic kidney disease (CHF), cirrhosis, gastrointestinal system (GIS), or endocrine disease
- Having been diagnosed with depression
- Being on enteral or parenteral nutrition
- Being a smoker
- Having a mental or communication disability that would prevent the patient from answering questions
- Having a body mass index of 30 or higher.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dumlupınar Family Health Center
Bursa, Nilüfer
About this study
Official title: The Effect Of Mediterranean Diet Education On Blood Pressure Levels And Quality Of Life Of Hypertensive Patiens
An experimental randomized controlled trial was conducted to evaluate the effects of Mediterranean diet education on blood pressure levels and quality of life in hypertensive patients. The sample size was determined using power analysis (n=70). Data were collected using a General Information Form, Physical Activity Questionnaire, Perceived Stress Scale, SF-36 Quality of Life Scale, and Mediterranean Diet Adherence Scale. Both groups were administered the questionnaire and blood pressure measurements at 0, 1, and 3 months. The first application was administered to the intervention group before the education session.
Read the detailed description
The experimental randomized controlled trial was conducted to evaluate the effect of Mediterranean diet education on blood pressure levels and quality of life in hypertensive patients. The sample size was determined using power analysis (n=70). Patients who met the inclusion criteria were assigned to the experimental (n=35) and control (n=35) groups using a simple randomization technique. Data were collected using the General Information Form, Physical Activity Questionnaire, Perceived Stress Scale, SF-36 Quality of Life Scale, and Mediterranean Diet Adherence Scale. Surveys and blood pressure measurements were administered to both groups at 0, 1, and 3 months. The initial application for the intervention group was conducted before the education session. In data evaluation, percentages, means, independent t-tests, Pearson chi-square tests, Yates chi-square tests, repeated measures variance analysis (ANOVA), Pearson correlation tests, and Bonferroni tests were used.
- Conditions
- Hypertension, Mediterranean Diet, Quality of Life
- Being tested
- Mediterranean diet education, Control
- Keywords
- Mediterranean diet, hypertension, quality of life, nutrition education, chronic disease management., blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet educationBehavioural
The General Information Form, Physical Activity Questionnaire, Perceived Stress Scale, SF-36 Quality of Life Scale, and Mediterranean Diet Adherence Scale will be administered to hypertensive patients at each interview (at 0, 1, and 3 months). The intervention group will be trained on the Mediterranean Diet at the first meeting.
ControlOther
The General Information Form, Physical Activity Questionnaire, Perceived Stress Scale, SF-36 Quality of Life Scale, and Mediterranean Diet Adherence Scale will be administered to hypertensive patients at each interview (at 0, 1, and 3 months).
| Study group | Role | What they receive |
|---|---|---|
| Diet education | Experimental | Mediterranean diet education Receives: Behavioral: Mediterranean diet education |
| Kontrol | Other | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediterranean diet adherence level
Mediterranean Diet Adherence Scale:The scale consists of 14 questions. Each question is scored 1 or 0, depending on the amount consumed, to calculate a total score. Total scores are used to determine dietary compliance: a score of ≤5 indicates low compliance, 6-9 indicates moderate compliance, and ≥10 indicates high compliance.
Measured: 0th month (1st day), 1st month and 3rd month
Quality of Life level
SF-36 Quality of Life Scale: The scale consists of 36 questions and eight subscales. Each subscale is scored separately from 0 to 100. Higher scores indicate better health.
Measured: 0th month (1st day), 1st month and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jul 2022
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hicran Yıldız, Uludag University
- Investigators
- Hicran Yıldız, Prof.Dr., Principal investigator, Bursa Uludag Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106567
- Sponsor's protocol ID
- H.Yıldız
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individuals included in the study were informed that the data obtained would be used and published only within the scope of this study, on condition that their identities remained confidential.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Mediterranean Diet Education On Blood Pressure Levels And Quality Of Life Of Hypertensive Patiens
- ClinicalTrials.gov ID
- NCT07106567
- Acronym / sponsor ID
- H.Yıldız
- Conditions
- Hypertension, Mediterranean Diet, Quality of Life
- Keywords
- Mediterranean diet, hypertension, quality of life, nutrition education, chronic disease management., blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 6 Aug 2025 (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.
An experimental randomized controlled trial was conducted to evaluate the effects of Mediterranean diet education on blood pressure levels and quality of life in hypertensive patients. The sample size was determined using power analysis (n=70). Data were collected using a General Information Form, Physical Activity Questionnaire, Perceived Stress Scale, SF-36 Quality of Life Scale, and Mediterranean Diet Adherence Scale. Both groups were administered the questionnaire and blood pressure measurements at 0, 1, and 3 months. The first application was administered to the intervention group before the education session.
Detailed description
The experimental randomized controlled trial was conducted to evaluate the effect of Mediterranean diet education on blood pressure levels and quality of life in hypertensive patients. The sample size was determined using power analysis (n=70). Patients who met the inclusion criteria were assigned to the experimental (n=35) and control (n=35) groups using a simple randomization technique. Data were collected using the General Information Form, Physical Activity Questionnaire, Perceived Stress Scale, SF-36 Quality of Life Scale, and Mediterranean Diet Adherence Scale. Surveys and blood pressure measurements were administered to both groups at 0, 1, and 3 months. The initial application for the intervention group was conducted before the education session. In data evaluation, percentages, means, independent t-tests, Pearson chi-square tests, Yates chi-square tests, repeated measures variance analysis (ANOVA), Pearson correlation tests, and Bonferroni tests were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| Diet education | Experimental | Behavioral: Mediterranean diet educationMediterranean diet education |
| Kontrol | Other | Other: Control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- - Being between 18 and 60 years of age
- Being willing and able to participate in the study
- Being diagnosed with primary hypertension at least 6 months ago
- Being in the inactive group according to the International Physical Activity Questionnaire
- Having a score of 35 or below on the Perceived Stress Scale
Key exclusion criteria (12 listed)
- - Having changed their eating habits in the last year
- If the patient is a woman, they are pregnant
- Having been diagnosed with an eating disorder
- Having been diagnosed with a psychiatric diagnosis and/or receiving psychological support
- Being on antidepressants and/or steroids
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 |
|---|---|---|
| Mediterranean diet educationThe General Information Form, Physical Activity Questionnaire, Perceived Stress Scale, SF-36 Quality of Life Scale, and Mediterranean Diet Adherence Scale will be administered to hypertensive patients at each interview (at 0, 1, and 3 months). The intervention group will be trained on the Mediterranean Diet at the first meeting. | Behavioural | Diet education |
| ControlThe General Information Form, Physical Activity Questionnaire, Perceived Stress Scale, SF-36 Quality of Life Scale, and Mediterranean Diet Adherence Scale will be administered to hypertensive patients at each interview (at 0, 1, and 3 months). | Other | Kontrol |
Primary outcome
Mediterranean diet adherence level
Time frame: 0th month (1st day), 1st month and 3rd month
Mediterranean Diet Adherence Scale:The scale consists of 14 questions. Each question is scored 1 or 0, depending on the amount consumed, to calculate a total score. Total scores are used to determine dietary compliance: a score of ≤5 indicates low compliance, 6-9 indicates moderate compliance, and ≥10 indicates high compliance.
Quality of Life level
Time frame: 0th month (1st day), 1st month and 3rd month
SF-36 Quality of Life Scale: The scale consists of 36 questions and eight subscales. Each subscale is scored separately from 0 to 100. Higher scores indicate better health.
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 Jul 2026.
- Individual participant dataSharing planned: No. Individuals included in the study were informed that the data obtained would be used and published only within the scope of this study, on condition that their identities remained confidential.
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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.
Hicran Yıldız, Prof.Dr. principal investigator
Bursa Uludag Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet education in people with Hypertension and Mediterranean Diet, run by Uludag 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 12 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 Jul 2026. 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 adherence level (time frame: 0th month (1st day), 1st month and 3rd month). 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 20 Jul 2026.