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Active Not Recruiting NCT07880366

The Effect of Lifestyle Program Women With PCOS

Conditions: Polycystic Ovary Syndrome

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Government College University Faisalabad

Location: Allied Hospital II, Faisalabad, Punjab, Pakistan Faisalābad Punjab Province

Summary

Polycystic Ovary Syndrome (PCOS) is a common hormonal condition affecting women of reproductive age. In addition to physical symptoms such as irregular menstruation, hormonal changes, and changes in body weight, women with PCOS may experience increased stress, difficulties in maintaining healthy lifestyle behaviors, and reduced quality of life. Lifestyle behaviors, including healthy eating, physical activity, and stress management, may play an important role in improving overall well-being among women with PCOS. This study examined the effect of a structured Lifestyle Modification Program on stress, healthy eating habits, health-promoting lifestyle behaviors, and PCOS-related quality of life among women diagnosed with PCOS. The program was based on the 5A's model: Assess, Advise, Agree, Assist, and Arrange, and was culturally adapted for women with PCOS. A total of 30 women with PCOS participated in the study. Participants were recruited from the Gynecology Department of Allied Hospital II, Faisalabad, and were placed into an experimental group (n = 15) or a control group (n = 15). The experimental group participated in a structured lifestyle modification program delivered through four sessions over two weeks. The program focused on healthy dietary practices, physical activity, stress management, and strategies for maintaining healthy lifestyle behaviors. The control group continued with routine clinical care. Participants completed assessments before and after the intervention. Measures assessed perceived stress, healthy eating habits, health-promoting lifestyle behaviors, and PCOS-related quality of life. The study was conducted to determine whether a structured lifestyle modification program could contribute to improvements in psychological well-being, healthy lifestyle behaviors, and quality of life among women with PCOS. The findings may help inform the integration of psychological and lifestyle-based interventions into the care of women with PCOS.

Eligibility Criteria

Inclusion Criteria: 3.3.1 Inclusion Criteria To be eligible for participation, individuals must meet the following criteria at the time of enrollment: * Aged between 18 and 45 years. * Formally diagnosed with PCOS based on clinical assessments. * Unmarried status. * Married, having no children * Free from co-occurring major chronic somatic diseases (such as cancer or type 1/type 2 diabetes). * Able and willing to sessional interventions. * Willing and capable of providing written, voluntary informed consent. 3.3.2 Exclusion Criteria Potential participants were excluded if they meet any of the following conditions: * Documented clinical diagnosis of diabetes (pre-existing or requiring active pharmacological management). * Currently receiving any other structured psychological therapy or specialized pharmacological weight-loss intervention that could confound the study outcomes. * Severe physical or physical health complications that prevent regular attendance or active participation in the low-GI diet and exercise routines. Exclusion Criteria: \-

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07880366). StuddyBuddy aggregates publicly available trial information.