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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Thomas Jefferson University
Information provided by (Responsible Party):
Nazia Raja-Khan, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01464398
First received: October 31, 2011
Last updated: October 3, 2014
Last verified: October 2014

October 31, 2011
October 3, 2014
December 2011
December 2014   (final data collection date for primary outcome measure)
Change from Baseline in Toronto Mindfulness Scale at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01464398 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Toronto Mindfulness Scale at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Hemoglobin A1c at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Hemoglobin A1c at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mean Arterial Pressure at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mean Arterial Pressure at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in SF-36 at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in SF-36 at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Brief Symptom Inventory-18 at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Brief Symptom Inventory-18 at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Toronto Mindfulness Scale at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Hemoglobin A1c at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Hemoglobin A1c at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mean Arterial Pressure at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mean Arterial Pressure at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in PCOS Quality of Life at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in PCOS Quality of Life at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Brief Symptom Inventory-18 at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Brief Symptom Inventory-18 at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)
Stress Reduction for PCOS and Non-PCOS Women

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Overweight
  • Obesity
  • Stress, Physiological
  • Stress, Psychological
  • Behavioral: Stress reduction
    8 weekly sessions
  • Behavioral: Stress reduction with Health education
    8 weekly sessions
  • Active Comparator: Stress reduction
    Intervention: Behavioral: Stress reduction
  • Active Comparator: Stress reduction with Health education
    Intervention: Behavioral: Stress reduction with Health education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
98
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion criteria:

  1. Current pregnancy
  2. Secondary causes of hyperandrogenemia, such as known or suspected androgen secreting tumors, Cushing's syndrome, or hyperprolactinemia (prolactin >30)
  3. Untreated hypothyroidism or hyperthyroidism (defined as TSH <0.2 or >5.5 mIU/mL)
  4. Severe active neuropsychological disorder such as psychosis or suicidal ideation
  5. 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.
  6. History of an inpatient admission for psychiatric disorder within the past two years
  7. Active alcohol or drug abuse
  8. Inability to read, speak or write English
  9. Inability to commit to the intervention and follow-up
  10. Current enrollment in a stress reduction program
  11. Mindfulness practice within the past 6 months (regular formal practice at least once a week)
  12. Current enrollment in other investigative studies
  13. Type 1 diabetes
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01464398
34145EP, K23AT006340
Yes
Nazia Raja-Khan, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • Thomas Jefferson University
Principal Investigator: Nazia Raja-Khan, MD Pennsylvania State University College of Medicine
Milton S. Hershey Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP