Evaluation of Comparative efficacy of Continuous vs. Stepwise Implementation Approaches for 12 -Month Lifestyle Medicine Interventions among Polycystic Ovarian Syndrome Patients: A Multicentric Randomized Controlled Trial

Polycystic Ovarian Syndrome (PCOS) is a commonly observed endocrine disease in women of reproductive age. Disrupted hormonal balance and metabolic disturbances distinguish it. Although Lifestyle Medicine (LM)  therapies are commonly advised for the treatment of PCOS, there is a scarcity of research that compares the outcomes between continuous and stepwise implementation approaches. LM is a medical specialty that uses therapeutic LM as a primary modality to treat chronic conditions. Applying the six pillars of LM, viz., whole-food, plant-predominant eating pattern, physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connections, provides effective prevention for these conditions.

The originality of this study is to assess the effectiveness and practicality of continuous implementation compared to stepwise implementation of LM therapies in enhancing health outcomes and quality of life among patients with PCOS. Addressing all six domains of LM at the initial stage of treatment can present challenges. It could result in a less positive reaction to the treatment. Our hypothesis suggests that implementing targeted domain treatment in a 2-1-2-1 format could potentially enhance the efficacy of the treatment.

The study aims to enlist individuals with PCOS from various centers and allocate them randomly to either the continuous or stepwise implementation groups. Here, a randomized controller trial for 12 months will assess hormonal profiles, polycystic ovarian morphology, menstrual regularity, metabolic parameters, and physical fitness, stress, circadian rhythm,sleep, diet, addiction, social connections, and quality of life among PCOS patients.