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
2 other identifiers
interventional
86
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMay 14, 2015
May 1, 2015
2.6 years
October 31, 2011
May 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Toronto Mindfulness Scale at 8 weeks
baseline and 8 weeks
Secondary Outcomes (9)
Change from Baseline in Toronto Mindfulness Scale at 16 weeks
baseline and 16 weeks
Change from Baseline in Hemoglobin A1c at 8 weeks
baseline and 8 weeks
Change from Baseline in Hemoglobin A1c at 16 weeks
baseline and 16 weeks
Change from Baseline in Mean Arterial Pressure at 8 weeks
baseline and 8 weeks
Change from Baseline in Mean Arterial Pressure at 16 weeks
baseline and 16 weeks
- +4 more secondary outcomes
Study Arms (2)
Stress reduction
ACTIVE COMPARATORMindfulness-based stress reduction
Stress reduction with Health education
ACTIVE COMPARATORGeneral stress management and health education
Interventions
8 weekly sessions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Related Publications (2)
Raja-Khan N, Agito K, Shah J, Stetter CM, Gustafson TS, Socolow H, Kunselman AR, Reibel DK, Legro RS. Mindfulness-Based Stress Reduction in Women with Overweight or Obesity: A Randomized Clinical Trial. Obesity (Silver Spring). 2017 Aug;25(8):1349-1359. doi: 10.1002/oby.21910. Epub 2017 Jul 7.
PMID: 28686006DERIVEDRaja-Khan N, Agito K, Shah J, Stetter CM, Gustafson TS, Socolow H, Kunselman AR, Reibel DK, Legro RS. Mindfulness-based stress reduction for overweight/obese women with and without polycystic ovary syndrome: design and methods of a pilot randomized controlled trial. Contemp Clin Trials. 2015 Mar;41:287-97. doi: 10.1016/j.cct.2015.01.021. Epub 2015 Feb 7.
PMID: 25662105DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nazia Raja-Khan, MD
Pennsylvania State University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 3, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
May 14, 2015
Record last verified: 2015-05