NCT05377021

Lifestyle Change in Women With Polycystic Ovary Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Dokuz Eylul University · Academic / Other
• Sex: Female
• Age: 20 Years – 41 Years
• Healthy volunteers: Accepted

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle change	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.

Timeline

• Start date: 2022-09-22
• Primary completion: 2023-09-22
• Completion: 2024-12-15
• First posted: 2022-05-17
• Last updated: 2025-09-18

Locations

1 site across 1 country: Turkey (Türkiye)