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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İzmir
-
Izmir, İzmir, Turkey (Türkiye)
- Dokuz Eylul University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: "Diet" group
|
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:
|
|
Experimental: "Diet and exercise combination" group
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
|
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
|
12 weeks
|
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
|
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.
|
12 weeks
|
|
The number of ovarian cysts
Time Frame: 12 weeks
|
Ultrasound measurements 12 weeks later
|
12 weeks
|
|
The value of hirsutism among PCOS symptoms between the groups
Time Frame: 12 weeks
|
Ferriman-Gallwey score (mFG) system was used for hirsutism.
|
12 weeks
|
|
The grade of alopecia among PCOS symptoms between the groups
Time Frame: 12 weeks
|
the Ludwig classification system was used.
|
12 weeks
|
|
The value of acne among PCOS symptoms between the groups
Time Frame: 12 weeks
|
The Global Acne Grading System was used.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DokuzEU123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.