Obesity, Overweight, Polycystic Ovary Syndrome, Stress, Physiological, Stress, Psychological
Conditions
Keywords
Polycystic Ovary Syndrome, stress, mindfulness, meditation, health education, women, overweight, obesity
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.
Interventions
BEHAVIORALStress reduction
8 weekly sessions
BEHAVIORALStress reduction with Health education
8 weekly sessions
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Thomas Jefferson University
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Toronto Mindfulness Scale at 8 weeks | baseline and 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 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 |
| Change from Baseline in SF-36 at 8 weeks | baseline and 8 weeks |
Countries
United States
Outcome results
None listed