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Women HealthPolycysticNCT07371364

Mobile Application for Women With Polycystic Ovary Syndrome

A study testing Mobile application in people with Women Health and Polycystic Ovary Syndrome (PCOS), run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: The aim is to develop a mobile application based on the Health Promotion Model for the management of PCOS and to determine the effect of this application on improving nutrition and exercise behavior in women with PCOS. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
Mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2026to 1 Aug 2026
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 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Being over 8 years old,
  • Being female,
  • Having a PCOS diagnosis,
  • Volunteering to participate in the study,
  • Having a mobile phone with Android or iOS operating system,
  • Having computer literacy (good phone usage skills),
  • Not having a diagnosed psychiatric illness.

Who cannot join

  • Pregnancy or planning to become pregnant during the study period,
  • The participant having a musculoskeletal, neurological, respiratory, or cardiovascular disease,
  • Having any surgery or health problem that would affect their ability to be physically active for more than one month, The participant not wanting to participate in the study for any reason,
  • The participant not having internet access.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Development and Evaluation of the Effectiveness of a Health Promotion Model Based Mobile Application for Women With Polycystic Ovary Syndrome

Objective: The aim is to develop a mobile application based on the Health Promotion Model for the management of PCOS and to determine the effect of this application on improving nutrition and exercise behavior in women with PCOS.

Method: The study population will consist of 114 women diagnosed with PCOS according to the Rotterdam criteria (2003) by a specialist in Obstetrics and Gynecology (G power 3.1.9.7). Inclusion criteria are being over 18 years old, female, diagnosed with PCOS, willingness to participate in the study, owning a smartphone with Android or iOS operating system, having digital literacy, and not having a diagnosed psychiatric condition. Exclusion criteria include being pregnant or planning to become pregnant during the study, having musculoskeletal, neurological, respiratory, or cardiovascular diseases, undergoing any surgery or having health issues that could affect physical activity for more than a month, unwillingness to participate in the study for any reason, and not having internet access. Participants will be randomly assigned to either the experimental or control group. The experimental group will receive a PCOS-specific exercise and nutrition program through the mobile app based on the Health Promotion Model, while the control group will receive the program via a pamphlet and it will be applied over 8 weeks. The mobile application will include an exercise program, nutrition counseling, and health coaching for PCOS management, all aligned with the Health Promotion Model. At the beginning and end of the study, participants' blood measurements, anthropometric measurements, physical activity levels, exercise behavior, and adherence to the Mediterranean Diet will be evaluated.

Read the detailed description

Introduction: Polycystic ovary syndrome (PCOS) is a lifelong endocrine disorder affecting 10 to 15% of women worldwide. Women with PCOS experience a range of physical and psychological issues, including hirsutism, acne, menstrual irregularities, hair loss, insulin resistance, metabolic syndrome, cardiovascular diseases, obesity, bipolar disorder, anxiety, depression, as well as sexual dysfunction and decreased quality of life. The most common problems associated with PCOS are menstrual irregularities, infertility, obesity, type 2 diabetes mellitus (T2DM), and metabolic syndrome. The primary goal of PCOS management is to improve hormonal and metabolic status, prevent future comorbid complications, and enhance the quality of life for young women with PCOS (Meczekalski et al. 2023). Literature review indicates that one of the most effective ways to improve quality of life in patients is through model-based educational interventions. In this context, one of the most comprehensive and widely used models for patient education provided by nurses is Pender's "Health Promotion Model." By creating a mobile application that facilitates adherence to physical activity and diet programs in the management of PCOS, it is expected to alleviate PCOS symptoms and improve women's quality of life.

Objective: The aim is to develop a mobile application based on the Health Promotion Model for the management of PCOS and to determine the effect of this application on improving nutrition and exercise behavior in women with PCOS.

Method: The study population will consist of 114 women diagnosed with PCOS according to the Rotterdam criteria (2003) by a specialist in Obstetrics and Gynecology (G power 3.1.9.7). Inclusion criteria are being over 18 years old, female, diagnosed with PCOS, willingness to participate in the study, owning a smartphone with Android or iOS operating system, having digital literacy, and not having a diagnosed psychiatric condition. Exclusion criteria include being pregnant or planning to become pregnant during the study, having musculoskeletal, neurological, respiratory, or cardiovascular diseases, undergoing any surgery or having health issues that could affect physical activity for more than a month, unwillingness to participate in the study for any reason, and not having internet access. Participants will be randomly assigned to either the experimental or control group. The experimental group will receive a PCOS-specific exercise and nutrition program through the mobile app based on the Health Promotion Model, while the control group will receive the program via a pamphlet and it will be applied over 8 weeks. The mobile application will include an exercise program, nutrition counseling, and health coaching for PCOS management, all aligned with the Health Promotion Model. At the beginning and end of the study, participants' blood measurements, anthropometric measurements, physical activity levels, exercise behavior, and adherence to the Mediterranean Diet will be evaluated.

Being tested
Mobile application, control group
Keywords
Polycystic Ovary Syndrome, Mobile application, Exercises, nutrition, health promotion
Medical subject headings
Polycystic Ovary Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile applicationOther

    Women with PCOS in this group will be included in a regular aerobic and strengthening exercises and nutrition program for 8 weeks using the mobile application.

  • control groupOther

    The control group will be given a PCOS-specific exercises or nutrition program via a handout.

Study groups in NCT07371364
Study groupRoleWhat they receive
Group 1: Mobile applicationExperimentalWomen with PCOS in this group will be included in a regular exercise and nutrition program for 8 weeks using the mobile application. The development and use of the mobile application by women with PCOS consists of several components: 1. Preparation and development of the mobile application content 2. Health coaching within the mobile application 3. Creation of exercise content within the mobile application 4. Creation of a nutrition program within the mobile application 5. Completion of evaluation forms via the mobile application 6. Obtaining reports on participants via the mobile application
Receives: Other: Mobile application
Group 2: Control groupExperimentalThe control group will be given a PCOS-specific exercise or nutrition program booklet.
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body mass index (BMI) assesment

    Participants' BMI will be calculated by dividing body weight (kg) by the square of their height in meters. It will be reported as kg/m^2)

    Measured: From enrollment to the end of treatment at 8 weeks

  2. Waist circumference measurement

    Waist circumference measurement will be performed with a measuring tape while the participant is standing. The measurement will be taken by locating the lowest rib cage on the right side of the body and the iliac crest and determining the midpoint between these points. It will be reported as cantimeter.

    Measured: From enrollment to the end of treatment at 8 weeks

  3. Hip circumference measurement

    Hip circumference measurement will be taken with a measuring tape while the person is standing on their side, at the widest part of their hips. It will be reported as cantimeter.

    Measured: From enrollment to the end of treatment at 8 weeks

  4. The International Physical Activity Questionnaire

    It which measures physical activity level, consists of 4 separate sections and a total of 7 questions. It assesses how many days in the past week, and for how long each day, individuals engaged in vigorous physical activity (PPE), moderate-intensity physical activity (MOI), and walking (W). The final question determines the time spent without movement (sitting, lying down, etc.). MET (Metabolic Equivalent Minutes) is used to determine physical activity level. 1 MET = 3.5 ml/kg/min. By determining how many days a week and for how long individuals engaged in vigorous physical activity, moderate-intensity physical activity, and walking, the total amount of METs expended from these three different physical activities is calculated. Physical activity level is determined in 3 categories: Category 1: Inactive (<300 MET-min/week), Category 2: Minimally Active (600-3000 MET-min/week), and Category 3: Always Active (>3000 MET-min/week).

    Measured: From enrollment to the end of treatment at 8 weeks

  5. Exercise Behavior Assessment

    This will be assessed using the Exercise Behavior Change Stages Questionnaire. This questionnaire was developed by Marcus and Lewis to identify the stages of exercise behavior (Marcus and Lewis, 2003). The questionnaire consists of four items. The items, which aim to determine participants' willingness to exercise, are answered with yes/no. Individuals are divided into five separate exercise behavior stages based on their responses to the items, according to their intentions and habits regarding exercise: Pre-tendency, Tendency, Preparation, Movement, and Continuity. The questions asked in the questionnaire are as follows: 1. I am currently engaged in moderate physical activity. 2. I intend to increase my participation in moderate physical activity within 6 months. 3. I am currently regularly engaged in moderate physical activity. 4. I have been regularly engaged in moderate physical activity for the last 6 months.

    Measured: From enrollment to the end of treatment at 8 weeks

  6. Adherence to the Mediterranean Diet

    Participants' adherence to the Mediterranean diet will be assessed using the 14-item Mediterranean Diet Adherence Scale (MEDAS), developed by Martínez-González et al. for the PREDIMED study. The 14 questions on the scale will be administered by the researcher through face-to-face interviews with individuals. The Mediterranean Diet Adherence Scale scoring range is 0-14 points. Diet adherence scores of <5 will be considered poor adherence, 6-9 moderate adherence, and ≥10 good adherence.

    Measured: From enrollment to the end of treatment at 8 weeks

  7. Blood measurements

    Assessment of insulin resistance and lipid profile; Fasting glucose, Glycated Hemoglobin (HbA1c), HOMA-IR will be done.

    Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2026
  2. Study start15 Jan 2026
  3. Primary completion1 Mar 2026
  4. Study completion1 Aug 2026

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07371364
Sponsor's protocol ID
E-10840098-202.3.02-1425
Other IDs
224S421
Acronym
Polycystic
Status last verified
Sep 2026
First submitted
12 Jan 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD supporting this study's findings are available from the corresponding author upon reasonable request.

Publications

  • Lee H, Lee SH. Effectiveness of an Integrated Mobile Application for Lifestyle Modifications in Overweight Women with Polycystic Ovarian Syndrome: A Randomized Controlled Trial. Life (Basel). 2023 Jul 10;13(7):1533. doi: 10.3390/life13071533.

    PubMed 37511908

Questions about this trial

What is this clinical trial studying?

A study testing Mobile application in people with Women Health and Polycystic Ovary Syndrome (PCOS), run by Istanbul Medipol University Hospital 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 7 inclusion and 4 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 9 Sep 2026. 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?

Body mass index (BMI) assesment (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07371364, which also lists 1 linked publication.

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 9 Sep 2026.

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