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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


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
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