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Completed

NCT Number: NCT05377021

Lifestyle Change in Women With Polycystic Ovary Syndrome

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.

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Key information

Age range

20 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylül University

Izmir, İzmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Lifestyle change in women with polycystic ovary syndrome

Primary outcomes

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

    Time frame: 12 weeks

    Monthly average number of steps between groups

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

    Time frame: 12 weeks

    Average monthly calorie intake between groups

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

    Time frame: 12 weeks

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

Secondary outcomes

  1. Quality of life of women with polycystic ovary syndrome

    Time frame: 12 weeks

    Quality of life assessed by Utian Quality of Life Scale. This scale consists of five-point Likert type, 23 items and four sub-dimensions (health, emotional, sexual and occupational quality of life). The lowest score that can be obtained from the scale is 23, and the highest score is 115. An increase in the scale and sub-dimension scores indicates that the quality of life increases. The Cronbach Alpha coefficient of the scale is 0.88.

  2. Satisfaction of women with polycystic ovary syndrome

    Time frame: 12 weeks

    Satisfaction assessed by Body Satisfaction Scale. This scale is five-point Likert type. It consists of two factors, general body satisfaction and investment in body image, and nine items. High scores from the scale reflect high body satisfaction. The Cronbach Alpha coefficient of the scale is 0.87.

  3. The number of ovarian cysts

    Time frame: 12 weeks

    Ultrasound measurements 12 weeks later

  4. The value of hirsutism among PCOS symptoms between the groups

    Time frame: 12 weeks

    Ferriman-Gallwey score (mFG) system was used for hirsutism.

  5. The grade of alopecia among PCOS symptoms between the groups

    Time frame: 12 weeks

    the Ludwig classification system was used.

  6. The value of acne among PCOS symptoms between the groups

    Time frame: 12 weeks

    The Global Acne Grading System was used.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 17, 2022
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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