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临床试验/NCT05377021
NCT05377021已完成不适用

A New Approach Intended for the Examination of "Diet" and "Diet and Exercise Combination" Interventions in Obese Women With Polycystic Ovary Syndrome

Dokuz Eylul University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
The smartwatch was evaluated as the primary outcome measure to assess the difference between the two groups.

研究概览

简要总结

This project aims to compare "diet" and "diet and exercise combination" interventions in obese women with polycystic ovary syndrome.

This project will be carried out in the Dokuz Eylül University Research and Application Hospital gynecology outpatient clinic between June 1, 2022 and June 1, 2024. The purpose of the project will be explained to women who meet the sampling criteria, and their informed consent will be obtained. A prospective and randomized comparison of "diet" and "diet and exercise combination" interventions, which are among the first-line treatment lifestyle changes recommended for PCOS, will be done. In the project, 33 women in the first group will receive "diet" intervention for 12 weeks, and 33 women in the second group will receive "diet and exercise combination" intervention. "Descriptive Characteristics Form" will be filled in for both groups, then at the beginning and at the end of the project, routine ultrasonography and laboratory test parameters for PCOS diagnosis criteria and menstrual cycle characteristics will be recorded, hirsutism score, alopecia score and acne level will be evaluated, the Utian Quality of Life Scale, Body Appreciation Scale, and the Short Form of the Oxford Happiness Questionnaire will be filled out. Body composition analysis will be performed in both groups at the beginning of the project, in the fourth and eighth weeks, and personal dietary recommendations will be given. Kitchen scales will be given to both groups to adapt to dietary recommendations and a mobile nutrition application will be used to record their diets. Person-specific exercise recommendations will be given to the second group at the beginning of the project, in the fourth and eighth weeks. In addition, women will be informed with a guide to behavioral changes specific to PCOS, which will be prepared specific to their group. Exercise parameters will be recorded by giving the same mobile application. Mobile nutrition application data will be collected via e-mail in the fourth, eighth and twelfth weeks of the project.

研究设计

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

入排标准

年龄范围
20 Years 至 41 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being between 20-41 years old,
  • Diagnosis of polycystic ovary syndrome,
  • Having a secondary education or higher education,
  • Having a body mass index of 30 and above,
  • Volunteering to participate in the research

排除标准

  • Having a psychiatric diagnosis,
  • Using a contraceptive method containing hormones in the last three months,
  • Presence of one or more of the etiologies of hyperprolactinemia, thyroid dysfunction, Cushing's syndrome, congenital adrenal hyperplasia and other hyperandrogenemia,
  • Diagnosis of hypertension, Type 1 or Type 2 Diabetes Mellitus,
  • Using one or more of the drug types such as antiandrogen, steroid, antidiabetic, ovulation induction agents in the last three months,
  • Impairment of liver, kidney or heart functions,
  • Limited physical exercise

结局指标

主要结局

The smartwatch was evaluated as the primary outcome measure to assess the difference between the two groups.

时间窗: 12 weeks

Monthly average number of steps between groups

The mobile nutrition app was evaluated as the primary outcome measure to assess the difference between the two groups.

时间窗: 12 weeks

Average monthly calorie intake between groups

Changes in body mass index (BMI) of women with polycystic ovary syndrome

时间窗: 12 weeks

Changes in BMI will be evaluated using kg/m\^2.

次要结局

  • Quality of life of women with polycystic ovary syndrome(12 weeks)
  • Satisfaction of women with polycystic ovary syndrome(12 weeks)
  • Quality of life of women with polycystic ovary syndrome(12 weeks)
  • Satisfaction of women with polycystic ovary syndrome(12 weeks)
  • The number of ovarian cysts(12 weeks)
  • The value of hirsutism among PCOS symptoms between the groups(12 weeks)
  • The grade of alopecia among PCOS symptoms between the groups(12 weeks)
  • The value of acne among PCOS symptoms between the groups(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hülya Özberk

Principal Investigator

Dokuz Eylul University

研究点 (1)

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