Cardiovascular DiseasesNCT07123610
Mediterranean Diet Education in Shift Nurses: Effects on Sleep, Activity, and Health Parameters
A study testing Mediterranean Diet Education Program in people with Cardiovascular Diseases and Obesity Prevention, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of Mediterranean diet education on sleep quality, physical activity levels, blood parameters, and anthropometric measurements among shift-working nurses. Primary outcomes: Change in Mediterranean diet adherence and sleep quality scores from baseline to post-intervention. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Obesity Prevention, Atheroscleroses
- What is being tested?
- Mediterranean Diet Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2024to 9 Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Registered nurse working ≥3 rotating shifts per month at the study hospital
- Age 18-55 years
- Written informed consent
Who cannot join
- Pregnancy or lactation
- Current participation in another lifestyle or drug trial
- Diagnosed sleep disorder requiring pharmacotherapy
- Medical condition necessitating therapeutic diet incompatible with MedDiet principles
- Inability to attend ≥75 % of education session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Mediterranean Diet Education Given to Shift-Working Nurses and Sleep Quality, Physical Activity Level, Blood Parameters, and Anthropometric Measurements
This study aimed to evaluate the effects of Mediterranean diet education on sleep quality, physical activity levels, blood parameters, and anthropometric measurements among shift-working nurses.
Primary outcomes: Change in Mediterranean diet adherence and sleep quality scores from baseline to post-intervention.
Secondary outcomes: Changes in physical activity levels, anthropometric indices (e.g., BMI, waist-to-hip ratio), and blood parameters (fasting glucose, insulin, HOMA-IR, lipid profile).
Read the detailed description
Background Shift work misaligns endogenous circadian rhythms with environmental light-dark cycles, predisposing workers to poor sleep, metabolic dysregulation, weight gain and cardiometabolic disease. Observational and experimental evidence indicates that dietary patterns rich in plant foods, monounsaturated fats and lean proteins-exemplified by the Mediterranean diet (MedDiet)-can attenuate inflammation, improve lipid and glycaemic profiles, and enhance subjective well-being. Educational interventions that reinforce MedDiet principles may therefore represent a pragmatic, low-risk strategy to mitigate health risks in shift-working nurses.
Study Desing Design: Single-group, pre-post intervention study Setting: Private general hospital in Muğla, Türkiye Sample Size: 130 nurses (≈80 % women) employed in rotating shifts, aged 18-55 y Allocation: Not applicable (no comparison arm)
Participant Eligibility Inclusion Criteria Registered nurse working ≥3 rotating shifts per month at the study hospital Age 18-55 years Written informed consent Exclusion Criteria Pregnancy or lactation Current participation in another lifestyle or drug trial Diagnosed sleep disorder requiring pharmacotherapy Medical condition necessitating therapeutic diet incompatible with MedDiet principles Inability to attend ≥75 % of education sessions
Intervention Mediterranean Diet Education Programme (Weeks 1-4) Format: Four weekly face-to-face group sessions (60 min each) delivered by a registered dietitian trained in behavioural counselling.
Content:
Session 1: MedDiet pyramid, portion guidance, meal timing for shift workers Session 2: Practical meal planning; reading food labels; healthy cafeteria choices Session 3: Strategies to increase fruit, vegetable, legume and whole-grain intake; recipe demonstrations Session 4: Reducing ultra-processed foods, sugar-sweetened beverages and saturated fats; sustaining behaviour change Materials: Printed handbook (pyramid graphic, shopping lists, sample menus), online discussion forum and weekly motivational text messages.
Fidelity: Sessions follow a standardised script; attendance recorded; 10 % of sessions audited by a second dietitian.
Participants receive no meal provision; they are encouraged to apply learned principles during all shifts. No changes are made to hospital food service.
Data Collection and Management Questionnaires are administered electronically via a secure, password-protected platform. Anthropometric measurements are performed in duplicate by trained research staff following WHO protocols. Blood draws coincide with routine occupational health surveillance to minimise burden and cost. Data are de-identified upon entry; only the principal investigator retains the re-identification key in an encrypted file.
Data analysis The analysis of the data collected in the study was performed using the SPSS 21.0 software. Descriptive statistics such as arithmetic mean, frequency, standard deviation, and percentage values were utilized in the analysis. To determine whether the data showed a normal distribution, skewness and kurtosis values were examined, and these values were found to be between -2 and +2, indicating that the data followed a normal distribution. Accordingly, parametric tests were used for comparisons between groups based on demographic information and for examining relationships between scales. To compare the pre- and post-test results of the Mediterranean diet, sleep disorders, and physical activity scales with blood parameters, the Paired-Samples T-Test was used, while comparisons by gender were conducted using the Independent-Samples T-Test. For comparisons across age groups, One-Way ANOVA was performed, and Tukey's test was applied as the post hoc analysis. Additionally, Pearson correlation analysis was conducted to determine the relationships between nurses' Mediterranean diet education and their sleep quality, physical activity levels, blood parameters, and anthropometric measurements.
The internal consistency of the Mediterranean Diet Adherence Scale, developed by Özkan Pehlivanoğlu, Hüseyin Balcıoğlu, and İlhami Ünlüoğlu, was calculated as Cronbach's α = 0.829, indicating a high level of reliability. The Pittsburgh Sleep Quality Index, developed by Buysse et al. in 1989, demonstrated satisfactory internal consistency (Cronbach's α = 0.80), test-retest reliability, and construct validity. In their 2017 systematic review of physical activity assessment in amputees, Piazza, Ferreira, Minsky, Pires, and Silva reported a reproducibility coefficient of ρ = 0.81 (95% CI = 0.79-0.82).
Outcome Measures and Time Points Primary and secondary outcomes were assessed at baseline (Week 0) and after the intervention (Week 8), unless otherwise specified.
The primary outcomes of the study were adherence to the Mediterranean diet and sleep quality. Adherence was measured using the 14-item Mediterranean Diet Adherence Screener (MEDAS), a validated tool for assessing compliance with Mediterranean dietary principles. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI), a widely used self-report instrument for assessing subjective sleep patterns and disturbances.
The secondary outcomes included physical activity level, anthropometric measurements, blood biomarkers, and adverse events. Physical activity was assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Anthropometric data were collected through standardized procedures: height was measured at baseline using a stadiometer, and weight, body fat percentage, and skeletal muscle mass were evaluated at both time points using the Tanita MC-180 body composition analyzer. Waist and hip circumferences were measured with a non-elastic measuring tape.
Blood biomarkers were assessed via fasting venous blood samples collected and analyzed in the hospital laboratory. Parameters included fasting glucose, insulin, triglycerides, LDL cholesterol, HDL cholesterol, and total cholesterol. The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) was calculated using fasting glucose and insulin values.
In addition, potential adverse events were monitored continuously throughout the study using a structured questionnaire administered at regular intervals.
Ethical Considerations Ethical approval was obtained from the Bahçeşehir University Scientific Research and Publication Ethics Committee. The study complies with the Declaration of Helsinki and relevant local regulations. Participation is voluntary; nurses may withdraw at any time without affecting employment status or access to occupational health services. The intervention poses minimal risk (education only).
Recruitment begun May 2024 and finished November 2024.
- Conditions
- Cardiovascular Diseases, Obesity Prevention, Atheroscleroses, Hypertension, Type 2 Diabetes Mellitus (T2DM), Occupational Health
- Being tested
- Mediterranean Diet Education Program
- Keywords
- Nutritional intervention, Circadian rhythm, Metabolic health, Lifestyle modification, Workplace wellness
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Hypertension, Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet Education ProgramBehavioural
The intervention consists of a 4-week Mediterranean Diet Education Program designed specifically for nurses working rotating shifts.
The program included four weekly group sessions, each lasting approximately 60 minutes, delivered in-person by a registered dietitian with training in behavioral change and clinical nutrition. Sessions are interactive and supported by visual and printed educational materials.
Participants receive a printed handbook including a food pyramid graphic, portion guides, weekly shopping lists, and sample menus tailored to shift work schedules. They also gain access to a moderated online discussion group and receive weekly motivational text messages to reinforce key messages.
No food is provided directly.
| Study group | Role | What they receive |
|---|---|---|
| Shift working nurses | Experimental | Not described Receives: Behavioral: Mediterranean Diet Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEDAS Score
Change in Mediterranean Diet Adherence Score (MEDAS) Change in adherence to the Mediterranean diet as measured by the 14-item Mediterranean Diet Adherence Screener (MEDAS). This validated questionnaire assesses the frequency and quality of consumption of key Mediterranean dietary components. Scores range from 0 to 14, with higher scores indicating greater adherence.
Measured: Baseline (week 0) and post-intervention (week 8)
Secondary outcomes (5)
Change in Physical Activity
Change in physical activity level as measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF estimates weekly energy expenditure (in MET-minutes/week) across domains such as walking, moderate and vigorous activity.
Measured: Baseline (week 0), Postintervention (week 8)
BMI Change
Change in BMI calculated as weight (kg) divided by height squared (m²). Weight measured using the Tanita MC-180 body composition analyzer; height measured at baseline with a stadiometer. Body Mass Index (BMI) will be calculated using weight and height measurements. Weight was measured in kilograms (kg) and height was measured in meters (m). BMI was computed as weight (kg) divided by the square of height (m²) and reported in kg/m² as a single outcome measure.
Measured: Baseline (Week 0) and Post-Intervention (Week 8)
Sleep Quality
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). This 19-item self-report tool assesses subjective sleep quality, latency, duration, efficiency, disturbances, and daytime dysfunction. Scores range from 0 to 21; higher scores indicate poorer sleep quality.
Measured: baseline (week 0) postintervention (week 8)
Waist Hip Ratio
Change in waist-to-hip ratio (WHR), calculated by dividing waist circumference by hip circumference. Measurements obtained using a non-elastic measuring tape according to WHO standards.
Measured: Baseline (Week 0) and Post-Intervention (Week 8)
Change in Blood Results Profile
Change in fasting blood glucose levels, measured via venous blood draw in a hospital laboratory.
Changes in fasting insulin levels and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) Changes in serum lipid parameters, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, measured from fasting venous blood samples.
Measured: Baseline (Week 0) and Post-Intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start8 May 2024
- Primary completion9 Nov 2024
- Study completion9 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilayda Ozturk Altuncevahir, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123610
- Sponsor's protocol ID
- E-85646034-604.01-81176
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations.
Publications
Sun M, Feng W, Wang F, Li P, Li Z, Li M, Tse G, Vlaanderen J, Vermeulen R, Tse LA. Meta-analysis on shift work and risks of specific obesity types. Obes Rev. 2018 Jan;19(1):28-40. doi: 10.1111/obr.12621. Epub 2017 Oct 4.
PubMed 28975706Franzago M, Alessandrelli E, Notarangelo S, Stuppia L, Vitacolonna E. Chrono-Nutrition: Circadian Rhythm and Personalized Nutrition. Int J Mol Sci. 2023 Jan 29;24(3):2571. doi: 10.3390/ijms24032571.
PubMed 36768893
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Mediterranean Diet Education Given to Shift-Working Nurses and Sleep Quality, Physical Activity Level, Blood Parameters, and Anthropometric Measurements
- ClinicalTrials.gov ID
- NCT07123610
- Acronym / sponsor ID
- E-85646034-604.01-81176
- Conditions
- Cardiovascular Diseases, Obesity Prevention, Atheroscleroses, Hypertension, Type 2 Diabetes Mellitus (T2DM), Occupational Health
- Keywords
- Nutritional intervention, Circadian rhythm, Metabolic health, Lifestyle modification, Workplace wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 9 Nov 2024 (actual)
- First posted
- 14 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.
This study aimed to evaluate the effects of Mediterranean diet education on sleep quality, physical activity levels, blood parameters, and anthropometric measurements among shift-working nurses.
Primary outcomes: Change in Mediterranean diet adherence and sleep quality scores from baseline to post-intervention.
Secondary outcomes: Changes in physical activity levels, anthropometric indices (e.g., BMI, waist-to-hip ratio), and blood parameters (fasting glucose, insulin, HOMA-IR, lipid profile).
Detailed description
Background Shift work misaligns endogenous circadian rhythms with environmental light-dark cycles, predisposing workers to poor sleep, metabolic dysregulation, weight gain and cardiometabolic disease. Observational and experimental evidence indicates that dietary patterns rich in plant foods, monounsaturated fats and lean proteins-exemplified by the Mediterranean diet (MedDiet)-can attenuate inflammation, improve lipid and glycaemic profiles, and enhance subjective well-being. Educational interventions that reinforce MedDiet principles may therefore represent a pragmatic, low-risk strategy to mitigate health risks in shift-working nurses.
Study Desing Design: Single-group, pre-post intervention study Setting: Private general hospital in Muğla, Türkiye Sample Size: 130 nurses (≈80 % women) employed in rotating shifts, aged 18-55 y Allocation: Not applicable (no comparison arm)
Participant Eligibility Inclusion Criteria Registered nurse working ≥3 rotating shifts per month at the study hospital Age 18-55 years Written informed consent Exclusion Criteria Pregnancy or lactation Current participation in another lifestyle or drug trial Diagnosed sleep disorder requiring pharmacotherapy Medical condition necessitating therapeutic diet incompatible with MedDiet principles Inability to attend ≥75 % of education sessions
Intervention Mediterranean Diet Education Programme (Weeks 1-4) Format: Four weekly face-to-face group sessions (60 min each) delivered by a registered dietitian trained in behavioural counselling.
Content:
Session 1: MedDiet pyramid, portion guidance, meal timing for shift workers Session 2: Practical meal planning; reading food labels; healthy cafeteria choices Session 3: Strategies to increase fruit, vegetable, legume and whole-grain intake; recipe demonstrations Session 4: Reducing ultra-processed foods, sugar-sweetened beverages and saturated fats; sustaining behaviour change Materials: Printed handbook (pyramid graphic, shopping lists, sample menus), online discussion forum and weekly motivational text messages.
Fidelity: Sessions follow a standardised script; attendance recorded; 10 % of sessions audited by a second dietitian.
Participants receive no meal provision; they are encouraged to apply learned principles during all shifts. No changes are made to hospital food service.
Data Collection and Management Questionnaires are administered electronically via a secure, password-protected platform. Anthropometric measurements are performed in duplicate by trained research staff following WHO protocols. Blood draws coincide with routine occupational health surveillance to minimise burden and cost. Data are de-identified upon entry; only the principal investigator retains the re-identification key in an encrypted file.
Data analysis The analysis of the data collected in the study was performed using the SPSS 21.0 software. Descriptive statistics such as arithmetic mean, frequency, standard deviation, and percentage values were utilized in the analysis. To determine whether the data showed a normal distribution, skewness and kurtosis values were examined, and these values were found to be between -2 and +2, indicating that the data followed a normal distribution. Accordingly, parametric tests were used for comparisons between groups based on demographic information and for examining relationships between scales. To compare the pre- and post-test results of the Mediterranean diet, sleep disorders, and physical activity scales with blood parameters, the Paired-Samples T-Test was used, while comparisons by gender were conducted using the Independent-Samples T-Test. For comparisons across age groups, One-Way ANOVA was performed, and Tukey's test was applied as the post hoc analysis. Additionally, Pearson correlation analysis was conducted to determine the relationships between nurses' Mediterranean diet education and their sleep quality, physical activity levels, blood parameters, and anthropometric measurements.
The internal consistency of the Mediterranean Diet Adherence Scale, developed by Özkan Pehlivanoğlu, Hüseyin Balcıoğlu, and İlhami Ünlüoğlu, was calculated as Cronbach's α = 0.829, indicating a high level of reliability. The Pittsburgh Sleep Quality Index, developed by Buysse et al. in 1989, demonstrated satisfactory internal consistency (Cronbach's α = 0.80), test-retest reliability, and construct validity. In their 2017 systematic review of physical activity assessment in amputees, Piazza, Ferreira, Minsky, Pires, and Silva reported a reproducibility coefficient of ρ = 0.81 (95% CI = 0.79-0.82).
Outcome Measures and Time Points Primary and secondary outcomes were assessed at baseline (Week 0) and after the intervention (Week 8), unless otherwise specified.
The primary outcomes of the study were adherence to the Mediterranean diet and sleep quality. Adherence was measured using the 14-item Mediterranean Diet Adherence Screener (MEDAS), a validated tool for assessing compliance with Mediterranean dietary principles. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI), a widely used self-report instrument for assessing subjective sleep patterns and disturbances.
The secondary outcomes included physical activity level, anthropometric measurements, blood biomarkers, and adverse events. Physical activity was assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Anthropometric data were collected through standardized procedures: height was measured at baseline using a stadiometer, and weight, body fat percentage, and skeletal muscle mass were evaluated at both time points using the Tanita MC-180 body composition analyzer. Waist and hip circumferences were measured with a non-elastic measuring tape.
Blood biomarkers were assessed via fasting venous blood samples collected and analyzed in the hospital laboratory. Parameters included fasting glucose, insulin, triglycerides, LDL cholesterol, HDL cholesterol, and total cholesterol. The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) was calculated using fasting glucose and insulin values.
In addition, potential adverse events were monitored continuously throughout the study using a structured questionnaire administered at regular intervals.
Ethical Considerations Ethical approval was obtained from the Bahçeşehir University Scientific Research and Publication Ethics Committee. The study complies with the Declaration of Helsinki and relevant local regulations. Participation is voluntary; nurses may withdraw at any time without affecting employment status or access to occupational health services. The intervention poses minimal risk (education only).
Recruitment begun May 2024 and finished November 2024.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shift working nurses | Experimental | Behavioral: Mediterranean Diet Education Program |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Registered nurse working ≥3 rotating shifts per month at the study hospital
- Age 18-55 years
- Written informed consent
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Current participation in another lifestyle or drug trial
- Diagnosed sleep disorder requiring pharmacotherapy
- Medical condition necessitating therapeutic diet incompatible with MedDiet principles
- Inability to attend ≥75 % of education session
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 Education ProgramThe intervention consists of a 4-week Mediterranean Diet Education Program designed specifically for nurses working rotating shifts. The program included four weekly group sessions, each lasting approximately 60 minutes, delivered in-person by a registered dietitian with training in behavioral change and clinical nutrition. Sessions are interactive and supported by visual and printed educational materials. Participants receive a printed handbook including a food pyramid graphic, portion guides, weekly shopping lists, and sample menus tailored to shift work schedules. They also gain access to a moderated online discussion group and receive weekly motivational text messages to reinforce key messages. No food is provided directly. | Behavioural | Shift working nurses |
Primary outcome
MEDAS Score
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in Mediterranean Diet Adherence Score (MEDAS) Change in adherence to the Mediterranean diet as measured by the 14-item Mediterranean Diet Adherence Screener (MEDAS). This validated questionnaire assesses the frequency and quality of consumption of key Mediterranean dietary components. Scores range from 0 to 14, with higher scores indicating greater adherence.
5 secondary outcomes
Change in Physical Activity
Time frame: Baseline (week 0), Postintervention (week 8)
BMI Change
Time frame: Baseline (Week 0) and Post-Intervention (Week 8)
Sleep Quality
Time frame: baseline (week 0) postintervention (week 8)
Waist Hip Ratio
Time frame: Baseline (Week 0) and Post-Intervention (Week 8)
Change in Blood Results Profile
Time frame: Baseline (Week 0) and Post-Intervention (Week 8)
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 14 Aug 2025.
- Background: PubMed 28975706Sun M, Feng W, Wang F, Li P, Li Z, Li M, Tse G, Vlaanderen J, Vermeulen R, Tse LA. Meta-analysis on shift work and risks of specific obesity types. Obes Rev. 2018 Jan;19(1):28-40. doi: 10.1111/obr.12621. Epub 2017 Oct 4.
- Background: PubMed 36768893Franzago M, Alessandrelli E, Notarangelo S, Stuppia L, Vitacolonna E. Chrono-Nutrition: Circadian Rhythm and Personalized Nutrition. Int J Mol Sci. 2023 Jan 29;24(3):2571. doi: 10.3390/ijms24032571.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations.
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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.
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?
A study testing Mediterranean Diet Education Program in people with Cardiovascular Diseases and Obesity Prevention, run by Bahçeşehir 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 3 inclusion and 5 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 14 Aug 2025. 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?
MEDAS Score (time frame: Baseline (week 0) and post-intervention (week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07123610, which also lists 2 linked publications.
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 14 Aug 2025.