Abstract

Abstract Study question What is the impact of a three-component lifestyle intervention on the prevalence and severity of metabolic syndrome (MetS) in women with polycystic ovary syndrome (PCOS)? Summary answer This three-component lifestyle intervention was more successful in improving metabolic health in reproductive-aged women with PCOS compared to minimal treatment. What is known already Women with PCOS have increased risk of MetS, and both PCOS and MetS are associated with excess weight. Moreover, obesity exacerbates many of the metabolic abnormalities associated with PCOS. Multi-component lifestyle interventions are the first line treatment to improve weight. Previous studies in women with PCOS have described improvements in waist circumference, cholesterol, low-density lipoprotein and fasting insulin after (one-, or two-component) lifestyle interventions. However little is known about changes in the prevalence of MetS, continuous MetS severity z-score (cMetS z-score), different metabolic parameters and the effects of changes in weight per se after three-component lifestyle interventions. Study design, size, duration An randomized controlled trial (RCT) was performed and participants were either assigned to a one-year three-component (cognitive behavioural therapy, diet, exercise) lifestyle intervention (LSI), with or without additional short message service (SMS) support (SMS+ and SMS- respectively), both receiving 20 group sessions, or to care as usual (CAU, control) which consisted of advice to lose weight by methods of their own choosing. Overall, 183 women were included between August 2010 and March 2016. Participants/materials, setting, methods Women diagnosed with PCOS according to the Rotterdam 2003 criteria, aged 18-38 years, having a wish to conceive and a BMI >25 kg/m² were included at the Erasmus MC, The Netherlands. Outcome variables were evaluated every three months and included anthropometric measurements, ultrasound and an endocrine assessment. Multilevel linear and logistic regression was applied for longitudinal analyses. Main results and the role of chance The cMetS severity z-score decreased more in the SMS+ group vs CAU after one year (-0.39, p = 0.015). MetS changed with -21.6% (p = 0.037), -16.5% (p = 0.190) and +7.0% (p = 0.509) within the SMS-, SMS+ and CAU group respectively. Moreover, a post hoc analysis on the prevalence of MetS for both LSI groups combined vs CAU resulted in a difference of -25.9% (p = 0.046) after one year in favour of the LSI groups. Weight loss per se resulted in significant favourable effects on all metabolic parameters. Limitations, reasons for caution Dropout during lifestyle interventions is unfortunately a common phenomenon, and our RCT also suffered from considerable discontinuation rates which is a limitation. Therefore, we selected a statistical method (multilevel regression modelling) specifically designed to deal with such missing values. Wider implications of the findings These findings confirm that three-component lifestyle interventions aiming at a 5-10% weight loss should be recommended for all women with PCOS in order to improve metabolic health during their reproductive lifespan. Trial registration number NTR2450

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