Polycystic Ovary SyndromeNCT01464398
Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)
A study testing Stress reduction and Stress reduction with Health education in people with Polycystic Ovary Syndrome and Overweight, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Overweight, Obesity
- What is being tested?
- Stress reduction and Stress reduction with Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, age 18 years or older
- Body mass index (BMI) ≥ 25 kg/m2 (overweight or obese)
Who cannot join
- Current pregnancy
- Secondary causes of hyperandrogenemia, such as known or suspected androgen secreting tumors, Cushing's syndrome, or hyperprolactinemia (prolactin >30)
- Untreated hypothyroidism or hyperthyroidism (defined as TSH <0.2 or >5.5 mIU/mL)
- Severe active neuropsychological disorder such as psychosis or suicidal ideation
- 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.
- History of an inpatient admission for psychiatric disorder within the past two years
Show all 13Show fewer
- Active alcohol or drug abuse
- Inability to read, speak or write English
- Inability to commit to the intervention and follow-up
- Current enrollment in a stress reduction program
- Mindfulness practice within the past 6 months (regular formal practice at least once a week)
- Current enrollment in other investigative studies
- Type 1 diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
- Conditions
- Polycystic Ovary Syndrome, Overweight, Obesity, Stress, Physiological, Stress, Psychological
- Being tested
- Stress reduction, Stress reduction with Health education
- Keywords
- Polycystic Ovary Syndrome, stress, mindfulness, meditation, health education, women, overweight, obesity
- Medical subject headings
- Polycystic Ovary Syndrome, Overweight, Obesity, Stress, Psychological, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress reductionBehavioural
8 weekly sessions
Stress reduction with Health educationBehavioural
8 weekly sessions
| Study group | Role | What they receive |
|---|---|---|
| Stress reduction | Active comparator | Mindfulness-based stress reduction Receives: Behavioral: Stress reduction |
| Stress reduction with Health education | Active comparator | General stress management and health education Receives: Behavioral: Stress reduction with Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Toronto Mindfulness Scale at 8 weeks
Measured: baseline and 8 weeks
Secondary outcomes (9)
Change from Baseline in Toronto Mindfulness Scale at 16 weeks
Measured: baseline and 16 weeks
Change from Baseline in Hemoglobin A1c at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in Hemoglobin A1c at 16 weeks
Measured: baseline and 16 weeks
Change from Baseline in Mean Arterial Pressure at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in Mean Arterial Pressure at 16 weeks
Measured: baseline and 16 weeks
Change from Baseline in SF-36 at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in SF-36 at 16 weeks
Measured: baseline and 16 weeks
Change from Baseline in Brief Symptom Inventory-18 at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in Brief Symptom Inventory-18 at 16 weeks
Measured: baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Thomas Jefferson University
- Responsible party
- Principal investigator, Nazia Raja-Khan, Milton S. Hershey Medical Center
- Investigators
- Nazia Raja-Khan, MD, Principal investigator, Pennsylvania State University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464398
- Sponsor's protocol ID
- 34145EP
- Other IDs
- K23AT006340
- Status last verified
- May 2015
- First submitted
- 31 Oct 2011
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28686006Raja-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.
PubMed 25662105
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction for PCOS and Non-PCOS Women
- ClinicalTrials.gov ID
- NCT01464398
- Acronym / sponsor ID
- 34145EP
- Conditions
- Polycystic Ovary Syndrome, Overweight, Obesity, Stress, Physiological, Stress, Psychological
- Keywords
- Polycystic Ovary Syndrome, stress, mindfulness, meditation, health education, women, overweight, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Thomas Jefferson University
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress reduction | Active comparator | Behavioral: Stress reductionMindfulness-based stress reduction |
| Stress reduction with Health education | Active comparator | Behavioral: Stress reduction with Health educationGeneral stress management and health education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women, age 18 years or older
- Body mass index (BMI) ≥ 25 kg/m2 (overweight or obese)
Key exclusion criteria (13 listed)
- Current pregnancy
- Secondary causes of hyperandrogenemia, such as known or suspected androgen secreting tumors, Cushing's syndrome, or hyperprolactinemia (prolactin >30)
- Untreated hypothyroidism or hyperthyroidism (defined as TSH <0.2 or >5.5 mIU/mL)
- Severe active neuropsychological disorder such as psychosis or suicidal ideation
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress reduction8 weekly sessions | Behavioural | Stress reduction |
| Stress reduction with Health education8 weekly sessions | Behavioural | Stress reduction with Health education |
Primary outcome
Change from Baseline in Toronto Mindfulness Scale at 8 weeks
Time frame: baseline and 8 weeks
9 secondary outcomes
Change from Baseline in Toronto Mindfulness Scale at 16 weeks
Time frame: baseline and 16 weeks
Change from Baseline in Hemoglobin A1c at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in Hemoglobin A1c at 16 weeks
Time frame: baseline and 16 weeks
Change from Baseline in Mean Arterial Pressure at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in Mean Arterial Pressure at 16 weeks
Time frame: baseline and 16 weeks
Change from Baseline in SF-36 at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in SF-36 at 16 weeks
Time frame: baseline and 16 weeks
Change from Baseline in Brief Symptom Inventory-18 at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in Brief Symptom Inventory-18 at 16 weeks
Time frame: baseline and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Derived from this study: PubMed 28686006Raja-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.
- Derived from this study: PubMed 25662105Raja-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazia Raja-Khan, MD principal investigator
Pennsylvania State University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress reduction and Stress reduction with Health education in people with Polycystic Ovary Syndrome and Overweight, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Toronto Mindfulness Scale at 8 weeks (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01464398, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.