Back to resultsStress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)
Primary Purpose
Polycystic Ovary Syndrome, Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress reduction
Stress reduction with Health education
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, stress, mindfulness, meditation, health education, women, overweight, obesity
Eligibility Criteria
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
Sites / Locations
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Stress reduction
Stress reduction with Health education
Arm Description
Mindfulness-based stress reduction
General stress management and health education
Outcomes
Primary Outcome Measures
Change from Baseline in Toronto Mindfulness Scale at 8 weeks
Secondary Outcome Measures
Change from Baseline in Toronto Mindfulness Scale at 16 weeks
Change from Baseline in Hemoglobin A1c at 8 weeks
Change from Baseline in Hemoglobin A1c at 16 weeks
Change from Baseline in Mean Arterial Pressure at 8 weeks
Change from Baseline in Mean Arterial Pressure at 16 weeks
Change from Baseline in SF-36 at 8 weeks
Change from Baseline in SF-36 at 16 weeks
Change from Baseline in Brief Symptom Inventory-18 at 8 weeks
Change from Baseline in Brief Symptom Inventory-18 at 16 weeks
Full Information
NCT ID
NCT01464398
First Posted
October 31, 2011
Last Updated
May 13, 2015
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT01464398
Brief Title
Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)
Official Title
Stress Reduction for PCOS and Non-PCOS Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Thomas Jefferson University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Overweight, Obesity, Stress, Physiological, Stress, Psychological
Keywords
Polycystic Ovary Syndrome, stress, mindfulness, meditation, health education, women, overweight, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress reduction
Arm Type
Active Comparator
Arm Description
Mindfulness-based stress reduction
Arm Title
Stress reduction with Health education
Arm Type
Active Comparator
Arm Description
General stress management and health education
Intervention Type
Behavioral
Intervention Name(s)
Stress reduction
Intervention Description
8 weekly sessions
Intervention Type
Behavioral
Intervention Name(s)
Stress reduction with Health education
Intervention Description
8 weekly sessions
Primary Outcome Measure Information:
Title
Change from Baseline in Toronto Mindfulness Scale at 8 weeks
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Toronto Mindfulness Scale at 16 weeks
Time Frame
baseline and 16 weeks
Title
Change from Baseline in Hemoglobin A1c at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in Hemoglobin A1c at 16 weeks
Time Frame
baseline and 16 weeks
Title
Change from Baseline in Mean Arterial Pressure at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in Mean Arterial Pressure at 16 weeks
Time Frame
baseline and 16 weeks
Title
Change from Baseline in SF-36 at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in SF-36 at 16 weeks
Time Frame
baseline and 16 weeks
Title
Change from Baseline in Brief Symptom Inventory-18 at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in Brief Symptom Inventory-18 at 16 weeks
Time Frame
baseline and 16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazia Raja-Khan, MD
Organizational Affiliation
Pennsylvania State University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28686006
Citation
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.
Results Reference
derived
PubMed Identifier
25662105
Citation
Raja-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.
Results Reference
derived
Learn more about this trial
Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)
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