Mediterranean Diet And Blood Pressure In Hypertension

NCT ID: NCT07106567

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-07-22

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.

Detailed Description

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.

Conditions

Hypertension; Mediterranean Diet; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Diet education

Mediterranean diet education

Group Type: EXPERIMENTAL

Mediterranean diet education

Intervention Type: 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.

Kontrol

Group Type: OTHER

Control

Intervention Type: 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).

Interventions

Mediterranean diet education

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.

Intervention Type: BEHAVIORAL

Control

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

Hicran Yıldız

Prof.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hicran Yıldız, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Bursa Uludag Unversity

Locations

Dumlupınar Family Health Center

Bursa, Nilüfer, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

UludağU1

Identifier Type: -

Identifier Source: org_study_id