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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT006340 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Thomas Jefferson University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress reduction | Active Comparator | Mindfulness-based stress reduction |
|
| Stress reduction with Health education | Active Comparator | General stress management and health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress reduction | Behavioral | 8 weekly sessions |
| |
| Stress reduction with Health education |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Toronto Mindfulness Scale at 8 weeks | baseline and 8 weeks |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nazia Raja-Khan, MD | Pennsylvania State University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28686006 | Derived | 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. | |
| 25662105 | Derived | 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. |
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| Behavioral |
8 weekly sessions |
|
| 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 |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D050177 | Overweight |
| D009765 | Obesity |
| D013315 | Stress, Psychological |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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