Efficacy, Feasibility and Acceptability of a Mediterranean Diet Intervention on Hormonal, Metabolic and Anthropometric Measures in Overweight and Obese Women with Polycystic Ovary Syndrome: Study Protocol

Abstract

Polycystic ovary syndrome (PCOS) is a common endocrine condition in reproductive-aged women associated with metabolic, reproductive and psychological features. Lifestyle modification (diet/physical activity) is considered first-line treatment for PCOS. However, there is limited high-quality evidence to support therapeutic dietary interventions for PCOS beyond general population-based healthy eating guidelines. Adherence to a Mediterranean diet (MedDiet), with or without energy restriction, improves cardiometabolic health in populations including persons with or at high risk of cardiovascular disease and type 2 diabetes. However, there is limited research examining the MedDiet in PCOS. Therefore, this 12 week randomized controlled trial will investigate the efficacy of a MedDiet on cardiometabolic and hormonal parameters and explore its acceptability and feasibility in PCOS. Forty-two overweight and obese women with PCOS (aged 18-45 years) will be randomized to receive dietary advice consistent with Australian Dietary Guidelines or an ad libitum MedDiet intervention. All participants will receive fortnightly counselling to facilitate behaviour change. The primary outcomes will be changes in insulin resistance, glucose, total testosterone and sex hormone-binding globulin. Secondary outcomes include changes in body weight and feasibility and acceptability of the MedDiet intervention. The results of this study will provide further evidence on specific dietary approaches for management of PCOS.

Keywords: Mediterranean diet; acceptability; behaviour change techniques; feasibility; insulin resistance; polycystic ovary syndrome.

Figure 1

Overview of the study design and schedule.

Figure 2

The capability, opportunity and motivation behaviour (COM-B) model and its components [69].