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Completed

NCT Number: NCT01464398

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adherence Interventions Adnexal Diseases Behavior Behavioral Symptoms Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Health Behavior Health Education Medication Adherence Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Stress, Physiological Stress, Psychological Treatment Adherence and Compliance Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress Reduction

Behavioral

8 weekly sessions

Stress reduction with Health education

Behavioral

8 weekly sessions

Primary outcomes

  1. Change from Baseline in Toronto Mindfulness Scale at 8 weeks

    Time frame: baseline and 8 weeks

Secondary outcomes

  1. Change from Baseline in Toronto Mindfulness Scale at 16 weeks

    Time frame: baseline and 16 weeks

  2. Change from Baseline in Hemoglobin A1c at 8 weeks

    Time frame: baseline and 8 weeks

  3. Change from Baseline in Hemoglobin A1c at 16 weeks

    Time frame: baseline and 16 weeks

  4. Change from Baseline in Mean Arterial Pressure at 8 weeks

    Time frame: baseline and 8 weeks

  5. Change from Baseline in Mean Arterial Pressure at 16 weeks

    Time frame: baseline and 16 weeks

  6. Change from Baseline in SF-36 at 8 weeks

    Time frame: baseline and 8 weeks

  7. Change from Baseline in SF-36 at 16 weeks

    Time frame: baseline and 16 weeks

  8. Change from Baseline in Brief Symptom Inventory-18 at 8 weeks

    Time frame: baseline and 8 weeks

  9. Change from Baseline in Brief Symptom Inventory-18 at 16 weeks

    Time frame: baseline and 16 weeks

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Thomas Jefferson University

Registry information

Official study title

Stress Reduction for PCOS and Non-PCOS Women

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 3, 2011
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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