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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome

NCT01859663

Polycystic Ovary Syndrome Dietary Habits Physical Activity

COMPLETED

Mindfulness-based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PICOS)

NCT06665789

Obesity Polycystic Ovary Syndrome Stress

COMPLETED NA

Mood and Nutrition Interventions in Polycystic Ovary Syndrome

NCT01899001

Polycystic Ovary Syndrome (PCOS)

COMPLETED NA

The Effects of High-intensity and Moderate-intensity Exercise on Polycystic Ovary Syndrome

NCT05394935

Polycystic Ovary Syndrome Exercise Cerebrovascular Circulation

COMPLETED NA

Insulin and the Polycystic Ovary Syndrome--Weight Reduction Study

NCT00436865

Polycystic Ovary Syndrome Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome Overweight Obesity Stress, Physiological Stress, Psychological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stress reduction

Mindfulness-based stress reduction

Group Type ACTIVE_COMPARATOR

Stress reduction

Intervention Type BEHAVIORAL

8 weekly sessions

Stress reduction with Health education

General stress management and health education

Group Type ACTIVE_COMPARATOR

Stress reduction with Health education

Intervention Type BEHAVIORAL

8 weekly sessions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stress reduction

8 weekly sessions

Intervention Type BEHAVIORAL

Stress reduction with Health education

8 weekly sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No