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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Diet" group | Active Comparator |
| |
| "Diet and exercise combination" group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dokuz Eylül University | Izmir | İzmir | Turkey (Türkiye) |
Available from the researcher upon request.
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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A prospective and randomized comparison
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|
| 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 |
| The number of ovarian cysts | Ultrasound measurements 12 weeks later | 12 weeks |
| The value of hirsutism among PCOS symptoms between the groups | Ferriman-Gallwey score (mFG) system was used for hirsutism. | 12 weeks |
| The grade of alopecia among PCOS symptoms between the groups | the Ludwig classification system was used. | 12 weeks |
| The value of acne among PCOS symptoms between the groups | The Global Acne Grading System was used. | 12 weeks |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |