Lifestyle Change in Women With Polycystic Ovary Syndrome

NCT05377021 | Completed DMC

• 1 other identifier: DokuzEU123
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

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

  Monthly average number of steps between groups

  12 weeks

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

  Average monthly calorie intake between groups

  12 weeks

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

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

  12 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

"Diet" group

ACTIVE COMPARATOR

Behavioral: Lifestyle change

"Diet and exercise combination" group

EXPERIMENTAL

Behavioral: Lifestyle change

Interventions

Lifestyle change BEHAVIORAL

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.

Also known as: Lifestyle change in women with polycystic ovary syndrome

"Diet and exercise combination" group; "Diet" group

Eligibility Criteria

• Age: 20 Years - 41 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University

Izmir, İzmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A prospective and randomized comparison

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 17, 2022
• Study Start: September 22, 2022
• Primary Completion: September 22, 2023
• Study Completion: December 15, 2024
• Last Updated: September 18, 2025

Record last verified: 2022-05

Locations

TU (1)