Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)
This study is currently recruiting participants.
Verified February 2013 by Milton S. Hershey Medical Center
Sponsor:
Milton S. Hershey Medical Center
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: February 21, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Polycystic Ovary Syndrome Overweight Obesity Stress, Physiological Stress, Psychological |
Behavioral: Stress reduction Behavioral: Stress reduction with Health education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Stress Reduction for PCOS and Non-PCOS Women |
Resource links provided by NLM:
Further study details as provided by Milton S. Hershey Medical Center:
Primary Outcome Measures:
- Change from Baseline in Toronto Mindfulness Scale at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 72 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Stress reduction |
Behavioral: Stress reduction
8 weekly sessions
|
| Active Comparator: Stress reduction with Health education |
Behavioral: Stress reduction with Health education
8 weekly sessions
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464398
Contacts
| Contact: Nazia Raja-Khan, MD | 717-531-8395 | nrajakhan@psu.edu |
| Contact: Barbara Scheetz, BS | 717-531-4483 | bscheetz@psu.edu |
Locations
| United States, Pennsylvania | |
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Barbara Scheetz, BS 717-531-4483 bscheetz@hmc.psu.edu | |
| Principal Investigator: Nazia Raja-Khan, MD | |
| Sub-Investigator: Richard S Legro, MD | |
Sponsors and Collaborators
Milton S. Hershey Medical Center
Thomas Jefferson University
Investigators
| Principal Investigator: | Nazia Raja-Khan, MD | Pennsylvania State University College of Medicine |
More Information
No publications provided
| Responsible Party: | Nazia Raja-Khan, M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT01464398 History of Changes |
| Other Study ID Numbers: | 34145EP, K23AT006340 |
| Study First Received: | October 31, 2011 |
| Last Updated: | February 21, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Milton S. Hershey Medical Center:
|
Polycystic Ovary Syndrome stress mindfulness meditation |
health education women overweight obesity |
Additional relevant MeSH terms:
|
Obesity Polycystic Ovary Syndrome Stress, Psychological Overweight Overnutrition Nutrition Disorders Body Weight Signs and Symptoms Ovarian Cysts |
Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Behavioral Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013