Study design
PCOS
SECONDARY
This is a secondary analysis of data from a Randomized Controlled Trial (RCT) (ISRCTN48947168), previously described in Oberg et al. (In this study, we have focused on objectively measured sleep variables in the same population of over-weight/obese women with PCOS and measured the treatment effects of the four-month intervention within and between groups. Sleep-registration with actigraphy was initiated part of the way through the inclusion period resulting in 39 out of the 68 women with PCOS completing the sleep registration at baseline (22 in the behavioral modification intervention group and 17 in the minimal intervention group), and 28 women at four months (13 in the behavioral modification intervention group and 15 in the minimal intervention group). In addition, we have introduced a control group of 21 women with comparable BMI and age to the women with PCOS without any metabolic-, endocrine or other illness, and compared the baseline sleep variables from our whole population of over-weight/obese women with PCOS (n=39) with the controls. Written consent has been obtained from all study participants. The local ethics committee in Stockholm has approved the study (2012/146-31/3, 2012/1762-32, 2014/1406-32, 2020/00653).