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

Not Applicable

Completed

• Conditions: Obesity; Stress, Psychological; Overweight; Stress, Physiological; Polycystic Ovary Syndrome
• Interventions: Behavioral: Stress reduction with Health education; Behavioral: Stress reduction

• Registration Number: NCT01464398
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-31
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-03
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress reduction with Health education	Stress reduction with Health education	General stress management and health education
Stress reduction	Stress reduction	Mindfulness-based stress reduction

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Toronto Mindfulness Scale at 8 weeks	baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c at 16 weeks	baseline and 16 weeks
Change from Baseline in Mean Arterial Pressure at 16 weeks	baseline and 16 weeks
Change from Baseline in Brief Symptom Inventory-18 at 16 weeks	baseline and 16 weeks
Change from Baseline in Toronto Mindfulness Scale at 16 weeks	baseline and 16 weeks
Change from Baseline in SF-36 at 16 weeks	baseline and 16 weeks
Change from Baseline in Mean Arterial Pressure at 8 weeks	baseline and 8 weeks
Change from Baseline in SF-36 at 8 weeks	baseline and 8 weeks
Change from Baseline in Brief Symptom Inventory-18 at 8 weeks	baseline and 8 weeks
Change from Baseline in Hemoglobin A1c at 8 weeks	baseline and 8 weeks

Trial Locations

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States