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

Obesity Clinical Trial

Official title:

Stress Reduction for PCOS and Non-PCOS Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464398
• Other study ID #: 34145EP
• Secondary ID: K23AT006340
• Status: Completed
• Phase: N/A
• First received: October 31, 2011
• Last updated: May 13, 2015
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Polycystic Ovary Syndrome
• Stress, Physiological
• Stress, Psychological

Intervention

Behavioral:
• Stress reduction
8 weekly sessions
• Stress reduction with Health education
8 weekly sessions

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Center for Complementary and Integrative Health (NCCIH), Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Toronto Mindfulness Scale at 8 weeks		baseline and 8 weeks	No
Secondary	Change from Baseline in Toronto Mindfulness Scale at 16 weeks		baseline and 16 weeks	No
Secondary	Change from Baseline in Hemoglobin A1c at 8 weeks		baseline and 8 weeks	No
Secondary	Change from Baseline in Hemoglobin A1c at 16 weeks		baseline and 16 weeks	No
Secondary	Change from Baseline in Mean Arterial Pressure at 8 weeks		baseline and 8 weeks	No
Secondary	Change from Baseline in Mean Arterial Pressure at 16 weeks		baseline and 16 weeks	No
Secondary	Change from Baseline in SF-36 at 8 weeks		baseline and 8 weeks	No
Secondary	Change from Baseline in SF-36 at 16 weeks		baseline and 16 weeks	No
Secondary	Change from Baseline in Brief Symptom Inventory-18 at 8 weeks		baseline and 8 weeks	No
Secondary	Change from Baseline in Brief Symptom Inventory-18 at 16 weeks		baseline and 16 weeks	No