Polycystic Ovary SyndromeNCT05377021
Lifestyle Change in Women With Polycystic Ovary Syndrome
A study testing Lifestyle change in people with Polycystic Ovary Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Lifestyle change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2022to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Lifestyle change
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle changeBehavioural
Also called Lifestyle change in women with polycystic ovary syndrome
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.
| Study group | Role | What they receive |
|---|---|---|
| "Diet" group | Active comparator | Not described Receives: Behavioral: Lifestyle change |
| "Diet and exercise combination" group | Experimental | Not described Receives: Behavioral: Lifestyle change |
What is being measured
The primary outcome is the main question the study is designed to answer.
The smartwatch was evaluated as the primary outcome measure to assess the difference between the two groups.
Monthly average number of steps between groups
Measured: 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
Measured: 12 weeks
Changes in body mass index (BMI) of women with polycystic ovary syndrome
Changes in BMI will be evaluated using kg/m^2.
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 12 weeks
The number of ovarian cysts
Ultrasound measurements 12 weeks later
Measured: 12 weeks
The value of hirsutism among PCOS symptoms between the groups
Ferriman-Gallwey score (mFG) system was used for hirsutism.
Measured: 12 weeks
The grade of alopecia among PCOS symptoms between the groups
the Ludwig classification system was used.
Measured: 12 weeks
The value of acne among PCOS symptoms between the groups
The Global Acne Grading System was used.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start22 Sep 2022
- Primary completion22 Sep 2023
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective and randomized comparison
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Özberk, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377021
- Sponsor's protocol ID
- DokuzEU123
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available from the researcher upon request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach Intended for the Examination of "Diet" and "Diet and Exercise Combination" Interventions in Obese Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05377021
- Acronym / sponsor ID
- DokuzEU123
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective and randomized comparison
| Arm | Type | Receives |
|---|---|---|
| "Diet" group | Active comparator | Behavioral: Lifestyle change |
| "Diet and exercise combination" group | Experimental | Behavioral: Lifestyle change |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle changeAlso: Lifestyle change in women with polycystic ovary syndromeIn 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. | Behavioural | "Diet and exercise combination" group, "Diet" group |
Primary outcome
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
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
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.
6 secondary outcomes
Quality of life of women with polycystic ovary syndrome
Time frame: 12 weeks
Satisfaction of women with polycystic ovary syndrome
Time frame: 12 weeks
The number of ovarian cysts
Time frame: 12 weeks
The value of hirsutism among PCOS symptoms between the groups
Time frame: 12 weeks
The grade of alopecia among PCOS symptoms between the groups
Time frame: 12 weeks
The value of acne among PCOS symptoms between the groups
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Undecided. Available from the researcher upon request.
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle change in people with Polycystic Ovary Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The smartwatch was evaluated as the primary outcome measure to assess the difference between the two groups. (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.