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临床试验/NCT07106567
NCT07106567已完成不适用

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

Uludag University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Mediterranean diet adherence level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •- 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.

排除标准

  • •- 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.

研究组 & 干预措施

Diet education

Experimental

Mediterranean diet education

干预措施: Mediterranean diet education (Behavioral)

Kontrol

Other

干预措施: Control (Other)

结局指标

主要结局

Mediterranean diet adherence level

时间窗: 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.

Quality of Life level

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hicran Yıldız

Prof.Dr.

Uludag University

研究点 (1)

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