Lifestyle Change in Women With Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle change
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
"Diet" group
"Diet and exercise combination" group
Arm Description
Outcomes
Primary Outcome Measures
The change in the parameters of Follicle stimulating hormone (FSH)
The unit of mIU/mL will be used for the change in FSH.
The change in the parameters of Luteinizing hormone (LH)
The unit of mIU/mL will be used for the change in LH.
The change in the parameters of Estradiol (E2)
The unit of pg/ml will be used for the change in E2.
The change in the parameters of Sex hormone binding globulin (SHBG)
The unit of nmol/L will be used for the change in SHBG.
Secondary Outcome Measures
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.
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.
Changes in body mass index (BMI) of women with polycystic ovary syndrome
Changes in BMI will be evaluated using kg/m^2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05377021
Brief Title
Lifestyle Change in Women With Polycystic Ovary Syndrome
Official Title
A New Approach Intended for the Examination of "Diet" and "Diet and Exercise Combination" Interventions in Obese Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective and randomized comparison
Masking
Participant
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"Diet" group
Arm Type
Active Comparator
Arm Title
"Diet and exercise combination" group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle change
Other Intervention Name(s)
Lifestyle change in women with polycystic ovary syndrome
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in the parameters of Follicle stimulating hormone (FSH)
Description
The unit of mIU/mL will be used for the change in FSH.
Time Frame
12 weeks
Title
The change in the parameters of Luteinizing hormone (LH)
Description
The unit of mIU/mL will be used for the change in LH.
Time Frame
12 weeks
Title
The change in the parameters of Estradiol (E2)
Description
The unit of pg/ml will be used for the change in E2.
Time Frame
12 weeks
Title
The change in the parameters of Sex hormone binding globulin (SHBG)
Description
The unit of nmol/L will be used for the change in SHBG.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of life of women with polycystic ovary syndrome
Description
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.
Time Frame
12 weeks
Title
Satisfaction of women with polycystic ovary syndrome
Description
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.
Time Frame
12 weeks
Title
Changes in body mass index (BMI) of women with polycystic ovary syndrome
Description
Changes in BMI will be evaluated using kg/m^2.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Lifestyle Change in Women With Polycystic Ovary Syndrome
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