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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Mediterranean Diet Education Program
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.

Turkey (Türkiye)1 site
  • Bodrum Acıbadem Hospital

    Muğla, Bodrum

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07123610
Study groupRoleWhat they receive
Shift working nursesExperimentalNot described
Receives: Behavioral: Mediterranean Diet Education Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  1. First posted14 Aug 2025
  2. Study start8 May 2024
  3. Primary completion9 Nov 2024
  4. Study completion9 Nov 2024

Resources

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)
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 28975706
  • Franzago 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

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.

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