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

Stress Reduction for PCOS and Non-PCOS Women

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Polycystic Ovary Syndrome; Overweight; Stress, Psychological; Stress, Physiological
• Intervention / Treatment: Behavioral: Stress reduction; Behavioral: Stress reduction with Health education

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Thomas Jefferson University
• Investigators: Principal Investigator: Nazia Raja-Khan, MD, Pennsylvania State University College of Medicine

Publications and helpful links

General Publications

• Raja-Khan N, Agito K, Shah J, Stetter CM, Gustafson TS, Socolow H, Kunselman AR, Reibel DK, Legro RS. Mindfulness-Based Stress Reduction in Women with Overweight or Obesity: A Randomized Clinical Trial. Obesity (Silver Spring). 2017 Aug;25(8):1349-1359. doi: 10.1002/oby.21910. Epub 2017 Jul 7.
• Raja-Khan N, Agito K, Shah J, Stetter CM, Gustafson TS, Socolow H, Kunselman AR, Reibel DK, Legro RS. Mindfulness-based stress reduction for overweight/obese women with and without polycystic ovary syndrome: design and methods of a pilot randomized controlled trial. Contemp Clin Trials. 2015 Mar;41:287-97. doi: 10.1016/j.cct.2015.01.021. Epub 2015 Feb 7.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 3, 2011

Study Record Updates

• Last Update Posted (Estimate): May 14, 2015
• Last Update Submitted That Met QC Criteria: May 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: obesity; overweight; Polycystic Ovary Syndrome; mindfulness; meditation; stress; women; health education
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Body Weight; Polycystic Ovary Syndrome; Syndrome; Stress, Psychological; Overweight
• Other Study ID Numbers: 34145EP; K23AT006340 (U.S. NIH Grant/Contract)