Clinical trial NCT05377021: Lifestyle Change in Women with Polycystic Ovary Syndrome
Official title: A New Approach Intended for the Examination of "Diet" and "Diet and Exercise Combination" Interventions in Obese Women with Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 27
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective and randomized comparison
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The change in the parameters of Follicle stimulating hormone (FSH)
timeFrame: 12 weeks
measure: The change in the parameters of Luteinizing hormone (LH)
timeFrame: 12 weeks
measure: The change in the parameters of Estradiol (E2)
timeFrame: 12 weeks
measure: The change in the parameters of Sex hormone binding globulin (SHBG)
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life of women with polycystic ovary syndrome
timeFrame: 12 weeks
measure: Satisfaction of women with polycystic ovary syndrome
timeFrame: 12 weeks
measure: Changes in body mass index (BMI) of women with polycystic ovary syndrome
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
References: