Summary Objective Lifestyle intervention is the recommended first‐line treatment for overweight women with polycystic ovary syndrome (PCOS). However, the efficacy of lifestyle change in improving reproductive function is still unclear. Design A randomized controlled trial (RCT) with allocation to a behavioural modification programme (intervention) or minimal intervention (control) for 4 months with a follow‐up at 12 months. Patients Sixty‐eight women, aged 18‐40 years, body mass index (BMI) ≥ 27 kg/m2, fulfilling all Rotterdam PCOS criteria were randomized to treatment. Measurements The primary outcome was improved menstrual regularity. Secondary outcomes were ovulation and pregnancy rates. Results At 4 months, the weight loss was significant in the intervention group (−2.1%, P = 0.002) and nonsignificant in the control group (−1.0%). A higher proportion of patients in the intervention group improved menstrual regularity compared to the control group, mean difference 35% (95% CI: 16‐60), P = 0.003. There was no difference in ovulation rate between groups. Logistic regression analysis showed that intervention was the only predictor of improved menstrual function, OR 3.9 (95% CI: 1.3‐11.9). At 12 months, a total of 54% of the women improved menstrual regularity compared to baseline (P = 0.000) and 43% (P = 0.000) had confirmed ovulation. 38% of the women wishing to become pregnant succeeded within 1 year of study completion. Conclusions This is the first RCT in overweight women with PCOS showing efficacy in improving reproductive function following behavioural modification intervention in comparison with minimal intervention. Although extensive weight loss is difficult to achieve in these women, behavioural modification intervention can help improve reproductive function.

Objective Little is known about how lifestyle affects psychological well-being in overweight women with polycystic ovary syndrome (PCOS). We investigated the effects of behavioral modification on psychological well-being and the impact of well-being and personality traits on successful weight loss. Design A 4-month randomized controlled trial with a 12-month follow-up at a University Hospital. Methods Sixty-eight women with PCOS, aged 18 to 40 years with a BMI ≥27 kg/m2, were randomized (1:1) into a behavioral modification program (intervention) or minimal intervention (control). The outcome measures were the psychological well being index and the Swedish universities scales of personality. Results At baseline, 60% had a global psychological well being index corresponding to severe distress and 40% to moderate distress. There was no significant change in mean global well-being score at 4 months within or between groups. However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033). Anxiety and general health tended to differ between groups (P = .06, respectively) favoring intervention. In the whole population, women achieving ≥5% weight loss at 12 months (n = 18) were less anxious at baseline compared to those who had not (P = .004). Personality trait-analysis showed that the weight-loss group had higher social desirability (P = .033) and lower embitterment (P = .023). Conclusions Psychological well-being is severely impacted in overweight women with PCOS. Behavioral modification can positively impact dimensions of well-being, although not fully significant, compared to control treatment. Personality factors could contribute to the understanding of successful weight loss.

ContextSleep duration and sleep quality have important health implications although our knowledge of objectively measured sleep variables in women with Polycystic Ovary Syndrome (PCOS) is limited.ObjectiveTo compare sleep variables assessed by actigraphy in over-weight/obese women with PCOS and controls, and to assess sleep variables after behavioral modification intervention in comparison with minimal intervention in a randomized trial.DesignRandomized controlled trial, and a control group.SettingOutpatient gynecological clinic at a university hospital in Sweden.Participants39 women fulfilling all Rotterdam PCOS criteria, randomized to behavioral modification intervention or minimal intervention and 21 controls with no other metabolic disease, all aged 18‐40 years with a BMI ≥ 27 kg/m2.InterventionA four-month behavioral modification intervention including weekly group meetings focusing on behavioral and healthy lifestyle aspects. Minimal intervention reflecting standard care.Main outcome measureSleep durations and sleep efficiency assessed by actigraphy.ResultsCompared to the control group, women with PCOS had significantly shorter time in bed (501 vs 548 min, p= 0.049), sleep time over 24 hours (448 vs 567 min, p=0.005) and sleep time at night (434 vs 511 min, p=0.002), poorer sleep efficiency (87 vs 93%, p<0.001), and longer wakefulness after sleep onset (64 vs 38 min, p<0.001). However, total sleep time at night for women with PCOS (7.2hrs) was within the normal range. Following behavioral modification intervention, the reduction from baseline in sleep over 24 hours and in the daytime sleep were significant compared to the minimal intervention group (78 min, p=0.009 and 43 min, p=0.003 respectively).ConclusionsWe found over-weight/obese women with PCOS to have normal sleep duration, but worse sleep efficiency than controls. Behavioral modification intervention seems to reduce the amount of daytime sleep, suggesting improved sleep behavior.Clinical trials registrationhttps://doi.org/10.1186/ISRCTN48947168, identifier ISRCTN48947168.