Lifestyle Change in Women With Polycystic Ovary Syndrome

May 11, 2022 updated by: Hülya Özberk, Dokuz Eylul University

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 41 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: "Diet" group
Behavioral: Lifestyle change
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:
  • Lifestyle change in women with polycystic ovary syndrome
EXPERIMENTAL: "Diet and exercise combination" group
Behavioral: Lifestyle change
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:
  • Lifestyle change in women with polycystic ovary syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the parameters of Follicle stimulating hormone (FSH)
Time Frame: 12 weeks
The unit of mIU/mL will be used for the change in FSH.
12 weeks
The change in the parameters of Luteinizing hormone (LH)
Time Frame: 12 weeks
The unit of mIU/mL will be used for the change in LH.
12 weeks
The change in the parameters of Estradiol (E2)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2022

Primary Completion (ANTICIPATED)

April 1, 2024

Study Completion (ANTICIPATED)

June 20, 2024

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (ACTUAL)

May 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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