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

Study Overview
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Brief Summary
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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.

Official Title
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Stress Reduction for PCOS and Non-PCOS Women

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

Intervention / Treatment
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* Behavioral: Stress reduction
* Behavioral: Stress reduction with Health education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stress reduction<br>Mindfulness-based stress reduction | Behavioral: Stress reduction<br>* 8 weekly sessions<br>|
| Active Comparator: Stress reduction with Health education<br>General stress management and health education | Behavioral: Stress reduction with Health education<br>* 8 weekly sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Toronto Mindfulness Scale at 8 weeks |  | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Toronto Mindfulness Scale at 16 weeks |  | baseline and 16 weeks | 
| Change from Baseline in Hemoglobin A1c at 8 weeks |  | baseline and 8 weeks | 
| Change from Baseline in Hemoglobin A1c 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 Mean Arterial Pressure at 16 weeks |  | baseline and 16 weeks | 
| Change from Baseline in SF-36 at 8 weeks |  | baseline and 8 weeks | 
| Change from Baseline in SF-36 at 16 weeks |  | baseline and 16 weeks | 
| Change from Baseline in Brief Symptom Inventory-18 at 8 weeks |  | baseline and 8 weeks | 
| Change from Baseline in Brief Symptom Inventory-18 at 16 weeks |  | baseline and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, stress, mindfulness, meditation, health education, women, overweight, obesity