Status:
COMPLETED
Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Thomas Jefferson University
Conditions:
Polycystic Ovary Syndrome
Overweight
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effects of stress reduction on glucose, blood pressure, quality of life and overall health and well-being in overweight or obese women, either with Polycy...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Women, age 18 years or older
- Body mass index (BMI) ≥ 25 kg/m2 (overweight or obese)
- Exclusion criteria:
- Current pregnancy
- Secondary causes of hyperandrogenemia, such as known or suspected androgen secreting tumors, Cushing's syndrome, or hyperprolactinemia (prolactin \>30)
- Untreated hypothyroidism or hyperthyroidism (defined as TSH \<0.2 or \>5.5 mIU/mL)
- Severe active neuropsychological disorder such as psychosis or suicidal ideation
- Severe untreated depression or anxiety. Women with severe depression or anxiety will be allowed to participate if they are under the care of a mental health specialist as long as they have permission to do so from their mental health specialist and will continue to follow-up with their mental health specialist during the study.
- History of an inpatient admission for psychiatric disorder within the past two years
- Active alcohol or drug abuse
- Inability to read, speak or write English
- Inability to commit to the intervention and follow-up
- Current enrollment in a stress reduction program
- Mindfulness practice within the past 6 months (regular formal practice at least once a week)
- Current enrollment in other investigative studies
- Type 1 diabetes
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01464398
Start Date
November 1 2011
End Date
June 1 2014
Last Update
May 14 2015
Active Locations (1)
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1
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033