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Mobile Application for Women With Polycystic Ovary Syndrome

M

Medipol Health Group

Status

Active, not recruiting

Conditions

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

Treatments

Other: control group
Other: Mobile application

Study type

Interventional

Funder types

Other

Identifiers

NCT07371364
224S421 (Other Grant/Funding Number)
E-10840098-202.3.02-1425

Details and patient eligibility

About

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.

Full 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.

Enrollment

92 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

92 participants in 2 patient groups

Group 1: Mobile application
Experimental group
Description:
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
Treatment:
Other: Mobile application
Group 2: Control group
Experimental group
Description:
The control group will be given a PCOS-specific exercise or nutrition program booklet.
Treatment:
Other: control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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