Lifestyle Change in Women With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Behavioral: Lifestyle change


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective and randomized comparison
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet group<br> | Behavioral: Lifestyle change<br>* 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.<br>* Other names: Lifestyle change in women with polycystic ovary syndrome;|
| Experimental: Diet and exercise combination group<br> | Behavioral: Lifestyle change<br>* 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.<br>* Other names: Lifestyle change in women with polycystic ovary syndrome;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the parameters of Follicle stimulating hormone (FSH) | The unit of mIU/mL will be used for the change in FSH. | 12 weeks | 
| The change in the parameters of Luteinizing hormone (LH) | The unit of mIU/mL will be used for the change in LH. | 12 weeks | 
| The change in the parameters of Estradiol (E2) | The unit of pg/ml will be used for the change in E2. | 12 weeks | 
| The change in the parameters of Sex hormone binding globulin (SHBG) | The unit of nmol/L will be used for the change in SHBG. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of women with polycystic ovary syndrome | 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. | 12 weeks | 
| Satisfaction of women with polycystic ovary syndrome | 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. | 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 |