Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)

Completed · Not applicable

Conditions studied: Polycystic Ovary Syndrome, Overweight, Obesity, Stress, Physiological, Stress, Psychological

In brief

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 Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction treatment sessions will include one or more of the following activities: breathing exercises, meditation, stretching exercises or health education activities.

Key facts

Study ID

NCT01464398

Run by

Milton S. Hershey Medical Center

People needed

86

Starts

2011-11-01

Expected to finish

2014-06-01

Last updated by the study team

2015-05-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women, age 18 years or older
• Body mass index (BMI) ≥ 25 kg/m2 (overweight or obese)

You may not qualify if…

• 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

Where it is running

• Penn State College of Medicine, Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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