Mediterranean Diet And Blood Pressure In Hypertension

NCT07106567 | Completed

• 1 other identifier: UludağU1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hypertension; Mediterranean Diet; Quality of Life

Keywords

Mediterranean diet; hypertension; quality of life; nutrition education; chronic disease management.; blood pressure

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  0th month (1st day), 1st month and 3rd month

Study Arms (2)

Diet education

EXPERIMENTAL

Mediterranean diet education

Behavioral: Mediterranean diet education

Kontrol

OTHER

Other: Control

Interventions

Mediterranean diet education BEHAVIORAL

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.

Diet education

Control OTHER

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).

Kontrol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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
• 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.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Dumlupınar Family Health Center

Bursa, Nilüfer, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hicran Yıldız, Prof.Dr.

  Bursa Uludag Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: Quasi-experimental

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 6, 2025
• Study Start: July 1, 2022
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)