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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
86
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.
The control group will be given a PCOS-specific exercises or nutrition program via a handout.
Istanbul Medipol University
Istanbul, Turkey (Türkiye)
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)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 8 weeks
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