Clinical trial NCT01464398: Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)
Official title: Stress Reduction for PCOS and Non-PCOS Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Overweight
Obesity
Stress, Physiological
Stress, Psychological
Keywords: Polycystic Ovary Syndrome
stress
mindfulness
meditation
health education
women
overweight
obesity
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Thomas Jefferson University
First posted: 2011-11-03
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline in Toronto Mindfulness Scale at 8 weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change from Baseline in Toronto Mindfulness Scale at 16 weeks
timeFrame: baseline and 16 weeks
measure: Change from Baseline in Hemoglobin A1c at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in Hemoglobin A1c at 16 weeks
timeFrame: baseline and 16 weeks
measure: Change from Baseline in Mean Arterial Pressure at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in Mean Arterial Pressure at 16 weeks
timeFrame: baseline and 16 weeks
measure: Change from Baseline in SF-36 at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in SF-36 at 16 weeks
timeFrame: baseline and 16 weeks
measure: Change from Baseline in Brief Symptom Inventory-18 at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in Brief Symptom Inventory-18 at 16 weeks
timeFrame: baseline and 16 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Pennsylvania State University College of Medicine
name: Nazia Raja-Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.