Clinical trial · Interventional
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
NCT01464398CI-TRIAL-00017909completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
| Overweight | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Stress, Physiological | — | UNRESOLVED | — |
| Stress, Psychological | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stress reduction | Behavioral | — | UNRESOLVED |
| Stress reduction with Health education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Stress reduction
- description
- Mindfulness-based stress reduction
- interventionNames
- Behavioral: Stress reduction
- type
- ACTIVE_COMPARATOR
- label
- Stress reduction with Health education
- description
- General stress management and health education
- interventionNames
- Behavioral: Stress reduction with Health education
Primary outcomes (1)
- measure
- Change from Baseline in Toronto Mindfulness Scale at 8 weeks
- timeFrame
- baseline and 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDRaja-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. PMID 28686006
- DERIVEDRaja-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. PMID 25662105