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

This study is currently recruiting participants.
Verified September 2013 by Milton S. Hershey Medical Center
Sponsor:
Collaborators:
Thomas Jefferson University
Information provided by (Responsible Party):
Nazia Raja-Khan, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01464398
First received: October 31, 2011
Last updated: September 7, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Overweight
Obesity
Stress, Physiological
Stress, Psychological
Behavioral: Stress reduction
Behavioral: Stress reduction with Health education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stress Reduction for PCOS and Non-PCOS Women

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Change from Baseline in Toronto Mindfulness Scale at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Toronto Mindfulness Scale at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Hemoglobin A1c at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Hemoglobin A1c at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mean Arterial Pressure at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mean Arterial Pressure at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in SF-36 at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in SF-36 at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Brief Symptom Inventory-18 at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Brief Symptom Inventory-18 at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stress reduction Behavioral: Stress reduction
8 weekly sessions
Active Comparator: Stress reduction with Health education Behavioral: Stress reduction with Health education
8 weekly sessions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464398

Contacts
Contact: Nazia Raja-Khan, MD 717-531-8395 nrajakhan@psu.edu
Contact: Barbara Scheetz, BS 717-531-4483 bscheetz@psu.edu

Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Barbara Scheetz, BS    717-531-4483    bscheetz@hmc.psu.edu   
Principal Investigator: Nazia Raja-Khan, MD         
Sub-Investigator: Richard S Legro, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Thomas Jefferson University
Investigators
Principal Investigator: Nazia Raja-Khan, MD Pennsylvania State University College of Medicine
  More Information

No publications provided

Responsible Party: Nazia Raja-Khan, M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01464398     History of Changes
Other Study ID Numbers: 34145EP, K23AT006340
Study First Received: October 31, 2011
Last Updated: September 7, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Milton S. Hershey Medical Center:
Polycystic Ovary Syndrome
stress
mindfulness
meditation
health education
women
overweight
obesity

Additional relevant MeSH terms:
Obesity
Polycystic Ovary Syndrome
Stress, Psychological
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 16, 2014