Objective Long‐term weight loss is important and difficult to achieve for many women with polycystic ovary syndrome (PCOS). Lifestyle interventions (LS) in PCOS have shown moderate short‐term effects. Three‐component LS that combine nutrition advice, exercise, and cognitive behavioral therapy have not been tested in long‐term interventions. Methods Women (N = 183) with PCOS who were trying to conceive and had BMI > 25 kg/m2 were assigned to 20 group sessions of cognitive behavioral therapy combined with nutrition advice and exercise (LS with or without Short Message Service [SMS] via mobile phone) or care as usual (CAU). Results More weight loss was observed in LS than in CAU (P < 0.001). Adding SMS was even more effective (P = 0.017). In CAU, 13 of 60 (21.8%) succeeded in achieving a 5% weight loss, as did 32 of 60 (52.8%) in LS without SMS and 54 of 63 (85.7%) in LS with SMS. The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU. More than 18 of 60 (29.0%) of the women in CAU gained weight versus 5 of 60 (8.5%) and 2 of 63 (3.1%) in LS without or with SMS, respectively. The overall dropout rate was 116 of 183 (63.4%). Conclusions A three‐component LS program resulted in reasonable weight loss in women with PCOS. Adding SMS resulted in more weight loss.

BackgroundObesity in women with polycystic ovary syndrome (PCOS) negatively affects all clinical features, and a 5 to 10% weight loss has shown promising results on reproductive, metabolic and psychological level. Incorporating a healthy diet, increasing physical activity and changing dysfunctional thought patterns in women with PCOS are key points in losing weight. The biggest challenge in weight management programs is to achieve a reasonable and sustainable weight loss. The aim of this study is to explore whether Cognitive Behavioural Therapy (CBT) by a mental health professional, working in a multidisciplinary team with a dietician and a physical therapist (a three-component intervention), is more effective for weight loss in the long term, within 12 months. We will also explore whether mobile phone applications are effective in supporting behavioural change and sustainable weight loss.MethodsThe present study is a longitudinal randomized controlled trial (RCT) to study the effectiveness of a three-component 1-year cognitive-behavioural lifestyle intervention in overweight/obese women with PCOS. A total of 210 participants are randomly assigned to three groups: 1) CBT provided by the multidisciplinary team or; 2) CBT provided by the multidisciplinary team and Short Message Service (SMS) or; 3) usual care: encourage weight loss through publicly available services (control group). The primary aim of the 12-month intervention is to explore whether a three-component 1-year cognitive-behavioural lifestyle intervention is effective to decrease weight, when compared to usual care. Secondary outcomes include: the effect of the intervention on the PCOS phenotype, waist circumference, waist to hip ratio, ovulation rates, total testosterone, SHBG, free androgen index (FAI), AMH, hirsutism, acne, fasting glucose, blood pressure and all psychological parameters. Additionally, we assessed time to pregnancy, ongoing pregnancies, clinical pregnancies, miscarriages and birth weight.All outcome variables are measured at the start of the study, and again at 3 months, 6 months, nine months and 12 months.DiscussionWe expect that CBT provided by a multidisciplinary team, especially combined with SMS, is effective in developing a healthy lifestyle and achieving a long-term weight loss in women with PCOS. Losing 5– 10% body weight improves various PCOS characteristics. Consequently, we expect to show that CBT provided by a multidisciplinary team improves reproductive and metabolic outcomes, as well as quality of life, while at the same time being cost-effective.Trial registrationRegistered at the Netherlands National Trial Register with number NTR2450 on August 2nd, 2010.

Many women with Polycystic Ovary Syndrome (PCOS) report high depression rates. The relationship between PCOS and these high depression rates is unclear. Two-component lifestyle interventions have revealed short-term effects on depression scores in this group of women. In general, 3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT) are more effective in the long-term to improve emotional wellbeing. This has not yet been studied in women with PCOS. This study examined the effect of 20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight). In this secondary analysis, 155 women with PCOS and a BMI above 25 kg/m 2 were eligible. Depression scores decreased significantly in the LS programme compared to CAU (P = 0.045). In both the LS programme without SMS (P = 0.036) and the LS programme with SMS (P = 0.011) depression scores decreased while no change was observed in CAU (P = 0.875). Selfesteem scores improved significantly in the LS programme compared to CAU (P = 0.027). No differences in body image scores were observed in LS participants compared to CAU (P = 0.087), although body image improved significantly in both the LS without SMS (P = 0.001) and with SMS (P = 0.008) study arms. We found no significant mediating role by androgens in the relationship between LS participants and emotional well-being. Only weight-loss mediated the relationship between LS and self-esteem. To conclude, a threecomponent lifestyle intervention programme with or without additional SMS resulted in significant improvements in depression and self-esteem compared to CAU, in women with PCOS, obesity, and a wish to achieve a pregnancy. Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol did not mediate this effect. Weight loss mediated the effects