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

Penn State Health

Status: Completed

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

Treatments: Behavioral: Stress reduction; Behavioral: Stress reduction with Health education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01464398

K23AT006340 (U.S. NIH Grant/Contract)

34145EP

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Stress reduction

Active Comparator group

Description:

Mindfulness-based stress reduction

Treatment:

Behavioral: Stress reduction

Stress reduction with Health education

Active Comparator group

Description:

General stress management and health education

Treatment:

Behavioral: Stress reduction with Health education