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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
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

20 Years - 41 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    May 9, 2022
    Last Updated
    May 11, 2022
    Sponsor
    Dokuz Eylul University
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    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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