NCT07123610

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

July 31, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

Nutritional interventionCircadian rhythmMetabolic healthLifestyle modificationWorkplace wellness

Outcome Measures

Primary Outcomes (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.

    Baseline (week 0) and post-intervention (week 8)

Secondary Outcomes (5)

  • Change in Physical Activity

    Baseline (week 0), Postintervention (week 8)

  • BMI Change

    Baseline (Week 0) and Post-Intervention (Week 8)

  • Sleep Quality

    baseline (week 0) postintervention (week 8)

  • Waist Hip Ratio

    Baseline (Week 0) and Post-Intervention (Week 8)

  • Change in Blood Results Profile

    Baseline (Week 0) and Post-Intervention (Week 8)

Study Arms (1)

Shift working nurses

EXPERIMENTAL
Behavioral: Mediterranean Diet Education Program

Interventions

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.

Shift working nurses

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Registered nurse working ≥3 rotating shifts per month at the study hospital
  • Age 18-55 years
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bodrum Acıbadem Hospital

Muğla, Bodrum, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 28975706BACKGROUND
  • 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.

    PMID: 36768893BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesAtherosclerosisHypertensionDiabetes Mellitus, Type 2Metabolic Syndrome

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 14, 2025

Study Start

May 8, 2024

Primary Completion

November 9, 2024

Study Completion

November 9, 2024

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical and privacy considerations.

Locations