Long-term effects of a three-component lifestyle intervention on emotional well-being in women with Polycystic Ovary Syndrome (PCOS): A secondary analysis of a randomized controlled trial

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 well-being. 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/m2 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). Self-esteem 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 three-component 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 on self-esteem but not on depression and body-image. This suggests that lifestyle treatment independent of weight loss can reduce depression and body-image, but both lifestyle treatment and weight loss can improve self-esteem. Thus, a three-component lifestyle intervention based on CBT could prove successful in improving mood in women with PCOS who are overweight or obese and attempting to become pregnant

Dietary and/or physical activity interventions in women with overweight or obesity prior to fertility treatment : protocol for a systematic review and individual participant data meta-analysis

Funding Information: This project is partly supported by the Centre for Research Excellence in Women's Health in Reproductive Life (app1171592) through a project support grant. RW is supported by a National Health and Medical Research Council (NHRMC) Investigator grant (2009767). LM is supported by a Heart Foundation Future Leader Fellowship. Funding Information: AH reports consultancy for Ferring with respect to the development of a lifestyle app. BWM is supported by an NHMRC Investigator grant (GNT1176437). BWM reports personal fees from ObsEva and Merck, and travel support from Merck, outside the submitted work. RW reports grants from the NHMRC. TM is supported by a Future Leader in Diabetes Award from the European Foundation for the Study of Diabetes/Novo Nordisk Foundation (NNF19SA058975) and grants from the regional health authority in Central Norway. ATK reports personal fees from Merck for lectures. The other authors do not have competing interest to declare. Funding Information: This project is partly supported by the Centre for Research Excellence in Women’s Health in Reproductive Life (app1171592) through a project support grant. RW is supported by a National Health and Medical Research Council (NHRMC) Investigator grant (2009767). LM is supported by a Heart Foundation Future Leader Fellowship. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Peer reviewedPublisher PD

The clinical value of a longterm three-component lifestyle intervention in women with PCOS

Polycystic ovary syndrome (PCOS), the most common endocrine disorder in women of reproductive age, is associated with overweight and obesity. In turn, excess weight worsens the clinical presentation of PCOS. We designed a randomized controlled one-year three-component lifestyle intervention (LSI), with or without additional short message service (SMS+ or SMS-, respectively), to lose weight by aiming at changing cognitions, changing dietary habits, and encouraging and promoting physical activity. The control group comprised care as usual, which consisted of an advice to lose weight by methods of their own choosing. The general aim of this thesis was to determine whether this LSI, with or without SMS, had an effect on the clinical manifestations of PCOS in overweight and obese women who also had a wish to become pregnant. We found that the amount of weight loss was positively associated with the intensity of the program. All groups demonstrated improvements regarding PCOS characteristics, although these were more profound within the LSI groups. We also found that this lifestyle intervention was more successful in improving physical activity and metabolic health compared to usual care, and observed positive effects on mood and eating behaviour. In the end, we found no significant differences in conception resulting in live birth rates between the groups. Nonetheless, a large proportion of all participants eventually conceived spontaneously, and after LSI the number of uneventful pregnancies was higher compared to care as usual

The clinical value of a longterm three-component lifestyle intervention in women with PCOS

Polycystic ovary syndrome (PCOS), the most common endocrine disorder in women of reproductive age, is associated with overweight and obesity. In turn, excess weight worsens the clinical presentation of PCOS. We designed a randomized controlled one-year three-component lifestyle intervention (LSI), with or without additional short message service (SMS+ or SMS-, respectively), to lose weight by aiming at changing cognitions, changing dietary habits, and encouraging and promoting physical activity. The control group comprised care as usual, which consisted of an advice to lose weight by methods of their own choosing. The general aim of this thesis was to determine whether this LSI, with or without SMS, had an effect on the clinical manifestations of PCOS in overweight and obese women who also had a wish to become pregnant. We found that the amount of weight loss was positively associated with the intensity of the program. All groups demonstrated improvements regarding PCOS characteristics, although these were more profound within the LSI groups. We also found that this lifestyle intervention was more successful in improving physical activity and metabolic health compared to usual care, and observed positive effects on mood and eating behaviour. In the end, we found no significant differences in conception resulting in live birth rates between the groups. Nonetheless, a large proportion of all participants eventually conceived spontaneously, and after LSI the number of uneventful pregnancies was higher compared to care as usual

Pregnancy Outcomes in Women with PCOS: Follow-Up Study of a Randomized Controlled Three-Component Lifestyle Intervention

Women with polycystic ovary syndrome (PCOS) and excess weight often present with reproductive derangements. The first-line treatment for this population is a multi-component lifestyle intervention. This follow-up study of a randomized controlled trial based on data from the Dutch Perinatal registry was conducted to study the effect of a one-year three-component (cognitive behavioral therapy, healthy diet, and exercise) lifestyle intervention on pregnancy outcomes in women with PCOS and overweight or obesity. Women diagnosed with PCOS, a BMI ≥ 25 kg/m², and a wish to conceive were randomized to either three-component lifestyle intervention (LSI, n = 123), and care as usual (CAU, n = 60) where they were encouraged to lose weight autonomously. Conception resulting in live birth was 39.8% (49/123) within LSI and 38.3% (23/60) within CAU (p = 0.845). In total, 58.3% conceived spontaneously. Gestational diabetes (LSI: 8.2% vs. CAU: 21.7%, p = 0.133), hypertensive disorders (LSI: 8.2% vs. CAU 13.0%, p = 0.673), and preterm birth (LSI: 12.2% vs. CAU: 17.4%, p = 0.716) rates were all lower in LSI compared to CAU. This follow-up study showed no significant differences in conception resulting in live birth rates between LSI and CAU. Nonetheless, a large proportion eventually conceived spontaneously. Moreover, after LSI, the number of uneventful pregnancies was lower compared to care as usual

Metabolic health during a randomized controlled lifestyle intervention in women with PCOS

Context: Women with polycystic ovary syndrome (PCOS) have an increased risk of metabolic syndrome (MetS). Both PCOS and MetS are associated with excess weight. Objective: To examine the effect of a three-component lifestyle intervention (LSI) with or without short message service (SMS+ or SMS−, respectively) on the prevalence and severity of MetS and metabolic parameters, compared to care as usual (CAU). Design: Randomized controlled trial. Methods: Women diagnosed with PCOS and a BMI >25 kg/m2 (n = 183) were either assigned to a 1-year three-component (cognitive behavioural therapy, diet, and exercise) LSI, with or without SMS support, or to CAU which provided weight-loss advice only. Main outcome measures included changes in the prevalence of MetS, the continuous MetS severity z-score (cMetS z-score), metabolic parameters, and the impact of weight loss. Results: After 1 year, the decrease in the cMetS z-score was greater in the SMS+ group than the CAU group (−0.39, P = 0.015). The prevalence of MetS changed with −21.6% (P = 0.037), −16.5% (P = 0.190), and +7.0% (P = 0.509) in both LSI groups and CAU group, respectively. A post hoc analysis for both LSI groups combined vs CAU resulted in a MetS difference of −25.9% (P = 0.046). Moreover, weight loss per se resulted in significantly favourable effects on all metabolic parameters. Conclusions: This three-component LSI was more successful in improving metabolic health compared to CAU. Therefore, we recommend this intervention to women with PCOS and excess weight, provided that a clinically relevant weight loss is being pursued

Pregnancy Outcomes in Women with PCOS: Follow-Up Study of a Randomized Controlled Three-Component Lifestyle Intervention

Women with polycystic ovary syndrome (PCOS) and excess weight often present with reproductive derangements. The first-line treatment for this population is a multi-component lifestyle intervention. This follow-up study of a randomized controlled trial based on data from the Dutch Perinatal registry was conducted to study the effect of a one-year three-component (cognitive behavioral therapy, healthy diet, and exercise) lifestyle intervention on pregnancy outcomes in women with PCOS and overweight or obesity. Women diagnosed with PCOS, a BMI ≥ 25 kg/m², and a wish to conceive were randomized to either three-component lifestyle intervention (LSI, n = 123), and care as usual (CAU, n = 60) where they were encouraged to lose weight autonomously. Conception resulting in live birth was 39.8% (49/123) within LSI and 38.3% (23/60) within CAU (p = 0.845). In total, 58.3% conceived spontaneously. Gestational diabetes (LSI: 8.2% vs. CAU: 21.7%, p = 0.133), hypertensive disorders (LSI: 8.2% vs. CAU 13.0%, p = 0.673), and preterm birth (LSI: 12.2% vs. CAU: 17.4%, p = 0.716) rates were all lower in LSI compared to CAU. This follow-up study showed no significant differences in conception resulting in live birth rates between LSI and CAU. Nonetheless, a large proportion eventually conceived spontaneously. Moreover, after LSI, the number of uneventful pregnancies was lower compared to care as usual

Lifestyle treatment in women with polycystic ovary syndrome: predictors of weight loss and dropout

Background: Polycystic ovary syndrome (PCOS) affects 5%–10% of women in their reproductive years. Most women with PCOS struggle with obesity during their entire life. Knowing which determinants contribute to a successful lifestyle change is important to optimize treatment options for women with PCOS. Objective: This analysis of secondary outcome measures aimed to determine factors of ≥5% weight loss and dropout in all arms of the study and separately in the lifestyle intervention (LI) and control (care as usual [CAU]) groups. Study design: Women diagnosed with PCOS (N = 183) and a Body Mass Index (BMI) above 25 kg/m2 were included. Participants were assigned to (1) 20 lifestyle sessions involving cognitive behavioral therapy (CBT), (2) 20 lifestyle sessions involving CBT with additional short message service (SMS), or (3) to control (CAU). A generalized linear regression was performed to identify determinants of ≥5% weight loss. Logistic regression was performed to identify determinants of dropout. All models were corrected by including baseline weight as a covariate. Results: LI (OR 4.906, p =.001) was associated with ≥5% weight loss, while higher depression scores (OR 0.549, p =.013) had a negative association. Restraint eating was a positive factor for ≥5% weight loss in LI but a negative in CAU. Higher baseline weight (OR 1.033, p =.006), LI with SMS (OR 4.424, p =.002), and higher levels of androstenedione (OR 1.167, p =.026) were associated with dropout. Conclusions: Depression and eating behavior were associated with ≥5% weight loss. Women with PCOS should be screened for depression and eating behavior before a LI

Changes in eating behavior through lifestyle treatment in women with polycystic ovary syndrome (PCOS): a randomized controlled trial

Background : Eating behaviors like emotional eating, external eating and restrained eating play an important role in weight gain and weight loss in the general population. Improvements in eating behavior are important for long-term weight. This has not yet been studied in women with Polycystic Ovary Syndrome (PCOS). The aim of this study is to examine if a three-component lifestyle intervention (LI) is effective for improving disordered eating behavior in women with PCOS. Methods : Women diagnosed with PCOS (N = 183), with a body mass index (BMI) > 25 kg/m2 and trying to achieve a pregnancy were either assigned to 1 year of 20 group sessions of cognitive behavioral therapy (CBT) combined with nutritional advice and exercise with or without additional feedback through Short Message Service (SMS) or Care As Usual (CAU), which includes the advice to lose weight using publicly available services. Results : The Eating Disorder Examination Questionnaire (EDEQ) scores worsened in CAU (47.5%) and improved in the LI (4.2%) at 12 months. The difference between the LI and CAU was significant (P = 0.007) and resulted in a medium to large effect size (Cohen’s d: − 0.72). No significant differences were observed in EDEQ scores between LI with SMS compared to LI without SMS (Cohen’s d: 0.28; P = 0.399). Also, weight loss did not mediate the changes in eating behavior. An overall completion rate of 67/183 (36.6%) was observed. Conclusions : A three-component CBT lifestyle program resulted in significant improvements in disordered eating behavior compared to CAU. Changes in disordered eating behavior are important for long-term weight loss and mental health. Trial registration: NTR, NTR2450. Registered 2 August 2010, https://www.trialregister.nl/trial/2344

Long-term effects of a three-component lifestyle intervention on emotional well-being in women with Polycystic Ovary Syndrome (PCOS): A secondary analysis of a randomized controlled trial.

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 well-being. 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/m2 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). Self-esteem 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 three-component 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 on self-esteem but not on depression and body-image. This suggests that lifestyle treatment independent of weight loss can reduce depression and body-image, but both lifestyle treatment and weight loss can improve self-esteem. Thus, a three-component lifestyle intervention based on CBT could prove successful in improving mood in women with PCOS who are overweight or obese and attempting to become pregnant