Trials / Active Not Recruiting

Active Not RecruitingNCT07371364

Mobile Application for Women With Polycystic Ovary Syndrome

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

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 92 (estimated)

Sponsor: Istanbul Medipol University Hospital · Academic / Other
Sex: Female
Age: 18 Years – 40 Years
Healthy volunteers: Not accepted

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.

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.

Conditions

Interventions

Type	Name	Description
OTHER	Mobile application	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.
OTHER	control group	The control group will be given a PCOS-specific exercises or nutrition program via a handout.

Timeline

Start date: 2026-01-01
Primary completion: 2026-03-01
Completion: 2026-03-15
First posted: 2026-01-27
Last updated: 2026-01-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07371364. Inclusion in this directory is not an endorsement.