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

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01464398
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH), Thomas Jefferson University (Other)
• Enrollment: 86
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Overweight; Obesity; Stress, Physiological; Stress, Psychological	Behavioral: Stress reduction; Behavioral: Stress reduction with Health education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Stress Reduction for PCOS and Non-PCOS Women
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stress reduction Mindfulness-based stress reduction	Behavioral: Stress reduction; 8 weekly sessions
Active Comparator: Stress reduction with Health education General stress management and health education	Behavioral: Stress reduction with Health education; 8 weekly sessions

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in Toronto Mindfulness Scale at 8 weeks [baseline and 8 weeks]

Secondary Outcome Measures

1. Change from Baseline in Toronto Mindfulness Scale at 16 weeks [baseline and 16 weeks]

2. Change from Baseline in Hemoglobin A1c at 8 weeks [baseline and 8 weeks]

3. Change from Baseline in Hemoglobin A1c at 16 weeks [baseline and 16 weeks]

4. Change from Baseline in Mean Arterial Pressure at 8 weeks [baseline and 8 weeks]

5. Change from Baseline in Mean Arterial Pressure at 16 weeks [baseline and 16 weeks]

6. Change from Baseline in SF-36 at 8 weeks [baseline and 8 weeks]

7. Change from Baseline in SF-36 at 16 weeks [baseline and 16 weeks]

8. Change from Baseline in Brief Symptom Inventory-18 at 8 weeks [baseline and 8 weeks]

9. Change from Baseline in Brief Symptom Inventory-18 at 16 weeks [baseline and 16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center
• National Center for Complementary and Integrative Health (NCCIH)
• Thomas Jefferson University

Investigators

• Principal Investigator: Nazia Raja-Khan, MD, Pennsylvania State University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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
• Other Study ID Numbers: 34145EP; K23AT006340
• First Posted: Nov 3, 2011
• Last Update Posted: May 14, 2015
• Last Verified: May 1, 2015

• Keywords provided by Nazia Raja-Khan, M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism, Milton S. Hershey Medical Center: Polycystic Ovary Syndrome; stress; mindfulness; meditation; health education; women; overweight; obesity
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Overweight; Stress, Psychological

Study Results

No Results Posted as of May 14, 2015