40 Participants NeededMy employer runs this trial

Intervention for PCOS

AP
AS
Overseen ByAmber Sike
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how education and lifestyle changes can improve life quality for women with Polycystic Ovary Syndrome (PCOS) who also face obesity. Researchers aim to determine if these changes benefit body composition, heart health, and inflammation. Participants will be divided into two groups: one will continue their usual care, while the Intervention Group will receive PCOS education and lifestyle support. Women with PCOS, a BMI of 30 or higher, and who are not pregnant may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding how lifestyle changes can enhance well-being for women with PCOS.

Do I have to stop taking my current medications for the PCOS trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic glucocorticoid therapy for more than 7 days, you would not be eligible to participate.

What prior data suggests that this intervention is safe for PCOS?

Research has shown that lifestyle changes, such as diet and exercise, are generally safe for people with polycystic ovary syndrome (PCOS). These changes can improve weight, metabolism, and overall quality of life without causing major side effects. Many women with PCOS have benefited from structured education sessions and lifestyle adjustments. These approaches are usually well-tolerated, meaning most people do not experience serious issues. Therefore, joining a trial involving lifestyle changes for PCOS is considered a safe choice based on current evidence.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive educational and lifestyle modification approach for managing Polycystic Ovary Syndrome (PCOS), which is a shift from the typical focus on medication and hormone therapy. Unlike standard treatments that primarily involve oral contraceptives or metformin to regulate symptoms, this intervention emphasizes empowering participants through education and personalized lifestyle support. This unique focus could lead to sustainable, long-term improvements in health and quality of life for those with PCOS by addressing the root causes rather than just the symptoms.

What evidence suggests that this trial's treatments could be effective for PCOS?

Studies have shown that lifestyle changes can help women with polycystic ovary syndrome (PCOS). These changes often involve adjustments to diet, exercise, and daily habits. Research indicates that such modifications can regulate menstrual cycles and improve heart health and blood sugar levels. Some studies also suggest that these changes can enhance weight management, promote healthier body composition, and improve quality of life for those with PCOS. While results can vary, lifestyle changes are considered a promising way to manage PCOS symptoms. Participants in this trial will receive short-term comprehensive PCOS education along with lifestyle modification support as part of the intervention group.16789

Are You a Good Fit for This Trial?

This trial is for women aged 18-49 who have already been diagnosed with PCOS and are obese (BMI of 30 or higher). Participants must not be pregnant.

Inclusion Criteria

I have been diagnosed with PCOS and my BMI is 30 or higher.
I am a woman between 18 and 49 years old and I am not pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive comprehensive PCOS education and lifestyle modification support via synchronous virtual groups

4 months
Virtual group sessions

Follow-up

Participants are monitored for changes in health-related quality of life and metabolic outcomes

4 months

What Are the Treatments Tested in This Trial?

Interventions

  • Intervention Group

Trial Overview

The study looks at how a specific intervention affects quality of life in women with PCOS. It also measures changes in body fat, heart health markers, and inflammation. The design compares an intervention group to usual care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

American Academy of Family Physicians

Collaborator

Trials
13
Recruited
32,100+

Citations

Effect of Lifestyle Modifications on Polycystic Ovary Syndrome ...

Results: Thirteen studies met inclusion criteria. These studies offer mixed support for lifestyle interventions improving hyperandrogenism.

Lifestyle changes in women with polycystic ovary syndrome

To assess the effectiveness of lifestyle treatment in improving reproductive, anthropometric (weight and body composition), metabolic and quality of life ...

Impact of lifestyle interventions on reproductive and...

This systematic review examined the effectiveness of lifestyle interventions, including dietary, exercise, and behavioral modifications, in improving ...

Effectiveness of Lifestyle Modification in Polycystic Ovary ...

Lifestyle modification using combination therapy is a promising therapeutic approach that can be employed in the management of PCOS patients with obesity.

Effect of Lifestyle Modifications on Polycystic Ovary ...

There is some evidence that lifestyle interventions improve menstrual regularity, cardiometabolic health, and metabolic function. Almost all studies found ...

Lifestyle changes in women with polycystic ovary syndrome

Lifestyle intervention may improve a secondary (endocrine) reproductive outcome, the free androgen index (FAI) (MD ‐1.11, 95% confidence ...

Effectiveness of Lifestyle Modification on Health-Related ...

Women with PCOS should receive structured education about lifestyle modification next to treatment to ensure improvement, particularly in patient-centered care.

The Role of Lifestyle Interventions in PCOS Management

This systematic review aims to assess the scientific evidence regarding the role of lifestyle modifications (dietary changes, physical activity, and behavioral ...

Polycystic ovary syndrome

PCOS can adversely impact quality of life in substantial ways, and women with PCOS may experience anxiety, depression, eating disorders and/or a ...