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Completed

NCT Number: NCT07106567

Mediterranean Diet And Blood Pressure In Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Mediterranean Diet Quality of Life Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dumlupınar Family Health Center

Bursa, Nilüfer, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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.

Exclusion criteria

  • - 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.

Treatment and study plan

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.

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).

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

The Effect Of Mediterranean Diet Education On Blood Pressure Levels And Quality Of Life Of Hypertensive Patiens

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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