Mobile Application for Women With Polycystic Ovary Syndrome

NCT07371364 | Active Not Recruiting

• 2 other identifiers: E-10840098-202.3.02-1425224S421
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Women Health; Polycystic Ovary Syndrome (PCOS); Physiotherapy and Rehabilitation; Dietetics; Mobile Application

Keywords

Polycystic Ovary Syndrome; Mobile application; Exercises; nutrition; health promotion

Outcome Measures

Primary Outcomes (7)

• 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)

  From enrollment to the end of treatment at 8 weeks

• 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.

  From enrollment to the end of treatment at 8 weeks

• 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.

  From enrollment to the end of treatment at 8 weeks

• 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).

  From enrollment to the end of treatment at 8 weeks

• 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.

  From enrollment to the end of treatment at 8 weeks

• 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.

  From enrollment to the end of treatment at 8 weeks

• Blood measurements

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

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Group 1: Mobile application

EXPERIMENTAL

Women 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

Other: Mobile application

Group 2: Control group

EXPERIMENTAL

The control group will be given a PCOS-specific exercise or nutrition program booklet.

Other: control group

Interventions

Mobile application OTHER

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.

Group 1: Mobile application

control group OTHER

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

Group 2: Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Eligibility is based on biological sex due to the pathophysiology of PCOS.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37511908 BACKGROUND

Related Links

• Effectiveness of an Integrated Mobile Application for Lifestyle Modifications in Overweight Women with Polycystic Ovarian Syndrome: A Randomized Controlled Trial

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• MERVE YILMAZ MENEK

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 27, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 15, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)