TY - JOUR
T1 - Mindfulness-based stress reduction for overweight/obese women with and without polycystic ovary syndrome
T2 - Design and methods of a pilot randomized controlled trial
AU - Raja-Khan, Nazia
AU - Agito, Katrina
AU - Shah, Julie
AU - Stetter, Christy M.
AU - Gustafson, Theresa S.
AU - Socolow, Holly
AU - Kunselman, Allen R.
AU - Reibel, Diane K.
AU - Legro, Richard S.
N1 - Funding Information:
The study is funded by the National Institutes of Health (NIH) National Center for Complementary and Alternative Medicine (NCCAM) through Grant K23AT006340 (Raja-Khan). The study is also supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, NIH , through Grant UL1TR000127 . The content is solely the responsibility of the authors and does not necessarily represent the official views of NCCAM or NIH. We would also like to acknowledge the study research coordinator, the unblinded class schedulers, the MBSR supervisor, the study subjects, the independent monitoring committee and the Core Endocrine Lab.
Publisher Copyright:
© 2015 Elsevier Inc.
PY - 2015/3/1
Y1 - 2015/3/1
N2 - Introduction: 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 and design: Eighty six (86) women with body mass index≥25kg/m2, including 31 women with PCOS, have been randomized to 8weeks of MBSR or health education control, and followed for 16weeks. 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. Discussion: 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.
AB - Introduction: 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 and design: Eighty six (86) women with body mass index≥25kg/m2, including 31 women with PCOS, have been randomized to 8weeks of MBSR or health education control, and followed for 16weeks. 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. Discussion: 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.
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U2 - 10.1016/j.cct.2015.01.021
DO - 10.1016/j.cct.2015.01.021
M3 - Article
C2 - 25662105
AN - SCOPUS:84924069776
VL - 41
SP - 287
EP - 297
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
ER -