A three-component cognitive behavioural lifestyle program for preconceptional weight-loss in women with polycystic ovary syndrome (PCOS): a protocol for a randomized controlled trial

Abstract

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.

The Effect of Balanced Hypocaloric Diet on the Anthropometric and Basic Metabolic Indicators in Infertile Women with Gluteofemoral Obesity

“…Thus, there is no doubt the need for diet therapy at the stage of pre-conceptional preparation, there are more discussions regarding methods that will improve compliance with this method of treatment. So, currently in the Netherlands, a longitudinal randomized controlled study [30] of a one-year three-component intervention in the cognitive-behavioral lifestyle in overweight/obese women with PCOS is being conducted. The authors of the study expect to get a more significant effect in lifestyle modification and weight loss by 5% -10% during the work of the multidisciplinary team.…”

Effects of Exercise Intervention on the Improvement of Polycystic Ovary Syndrome

“…Diet and exercise were beneficial to improve endocrine and metabolic functions. Jiskoot et al [39] believed that multi-disciplinary lifestyle intervention through the combination of cognition, nutrition and exercise was more conducive to overweight/obese PCOS patients to develop a healthy lifestyle and achieved long-term weight loss, so as to improve the reproductive function, metabolic state and longterm life quality of overweight/obese PCOS women. A randomized controlled study of overweight/obese PCOS women followed a dietary intervention to lose weight for 4 months.…”

Modern Ways of Treatment of Metabolic Disorders in Women with Polycystic Ovarian Syndrome

“…First and foremost, a proper low-calorie diet with a low glycemic index should be recommended along with regular physical activity which improves psychological, reproductive and cardiovascular parameters for women with PCOS [9]. It is also important to give up smoking which increases adverse effects of the medicine prescribed for patients with PCOS; specifically, it leads to increased risks of thrombosis and endothelial dysfunction.…”