title: Mindfulness-based stress reduction for overweight/obese women with and without polycystic ovary syndrome: design and methods of a pilot randomized controlled trial.
abstract: BACKGROUND
  Mindfulness-based stress reduction (MBSR) may be beneficial for overweight/obese women, including women with polycystic ovary syndrome (PCOS), as it has been shown to reduce psychological distress and improve quality of life in other patient populations. Preliminary studies suggest that MBSR may also have salutary effects on blood pressure and blood glucose. This paper describes the design and methods of an ongoing pilot randomized controlled trial evaluating the feasibility and effects of MBSR in PCOS and non-PCOS women who are overweight or obese (NCT01464398).
  
  
  METHODS
  Eighty six (86) women with body mass index ≥ 25 kg/m(2), including 31 women with PCOS, have been randomized to 8 weeks of MBSR or health education control, and followed for 16 weeks. The primary outcome is mindfulness assessed with the Toronto Mindfulness Scale. Secondary outcomes include measures of blood pressure, blood glucose, quality of life, anxiety and depression.
  
  
  CONCLUSIONS
  Our overall hypothesis is that MBSR will increase mindfulness and ultimately lead to favorable changes in blood pressure, blood glucose, psychological distress and quality of life in PCOS and non-PCOS women. This would support the integration of MBSR with conventional medical treatments to reduce psychological distress, cardiovascular disease and diabetes in PCOS and non-PCOS women who are overweight or obese.
authors: Division of Endocrinology, Diabetes, and Metabolism, Pennsylvania State University College of Medicine, 500 University Drive, Hershey, PA 17033, USA. Electronic address: nrajakhan@psu.edu.
authors: Nazia
authors: N
authors: Raja-Khan
authors: Division of Endocrinology, Diabetes, and Metabolism, Pennsylvania State University College of Medicine, 500 University Drive, Hershey, PA 17033, USA.
authors: Katrina
authors: K
authors: Agito
authors: Division of Endocrinology, Diabetes, and Metabolism, Pennsylvania State University College of Medicine, 500 University Drive, Hershey, PA 17033, USA.
authors: Julie
authors: J
authors: Shah
authors: Department of Public Health Sciences, Pennsylvania State University College of Medicine, 500 University Drive, Hershey, PA 17033, USA.
authors: Christy M
authors: CM
authors: Stetter
authors: Department of Clinical Nutrition, Pennsylvania State University College of Medicine, 500 University Drive, Hershey, PA 17033, USA.
authors: Theresa S
authors: TS
authors: Gustafson
authors: Division of Endocrinology, Diabetes, and Metabolism, Pennsylvania State University College of Medicine, 500 University Drive, Hershey, PA 17033, USA.
authors: Holly
authors: H
authors: Socolow
authors: Department of Public Health Sciences, Pennsylvania State University College of Medicine, 500 University Drive, Hershey, PA 17033, USA.
authors: Allen R
authors: AR
authors: Kunselman
authors: Jefferson-Myrna Brind Center of Integrative Medicine, Thomas Jefferson University, 111 South 11th Street, Gibbon Building, Suite 6215, Philadelphia, PA 19107, USA.
authors: Diane K
authors: DK
authors: Reibel
authors: Department of Obstetrics and Gynecology, Pennsylvania State University College of Medicine, 500 University Drive, Hershey, PA 17033, USA.
authors: Richard S
authors: RS
authors: Legro
mesh_terms: D000328:Adult; D001007:Anxiety / Q000523:psychology / Q000628:therapy*; D003863:Depression / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D064866:Mindfulness / Q000379:methods*; D009765:Obesity / Q000150:complications / Q000523:psychology*; D050177:Overweight / Q000150:complications / Q000523:psychology; D010865:Pilot Projects; D011085:Polycystic Ovary Syndrome / Q000150:complications / Q000523:psychology*; D013315:Stress, Psychological / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Glucose; Obesity; Stress