Weight Loss Program for PCOS and Obesity (FLOWERS-PCOS Trial)

N/A

Waitlist Available

Led By Judy Shiau, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weight will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be done a pre-determined time as weight loss isn't linear/predictable.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how much weight patients with PCOS can lose in a 24-week intensive weight loss program called STREAM. They also want to see how other health markers like insulin sensitivity will improve

Who is the study for?

This trial is for females with obesity and Polycystic Ovary Syndrome (PCOS). Participants will engage in a 24-week intensive weight loss program called STREAM. They'll track their weight, undergo bloodwork, and fill out quality of life questionnaires regularly.

What is being tested?

The STREAM program's effectiveness on weight loss and health improvements in PCOS patients is being tested. The study focuses on how much weight participants lose and the changes in health markers like insulin sensitivity over the course of the program.

What are the potential side effects?

While not explicitly listed, potential side effects may include typical risks associated with lifestyle changes such as fatigue, nutritional deficiencies or muscle strains from increased physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will be asked to report on their menstrual cycles at the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every 5% weightloss milestone, which cannot be scheduled in advance as it isn't predictable/linear.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will be asked to report on their menstrual cycles at the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every 5% weightloss milestone, which cannot be scheduled in advance as it isn't predictable/linear.

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be asked to report on their menstrual cycles at the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every 5% weightloss milestone, which cannot be scheduled in advance as it isn't predictable/linear. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Endocrine parameters (EP) as measure by blood test

Change in Lipid profile (LP) as measure by blood test

Change in Menstrual Cyclicity

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: STREAM Weight-loss ProgramExperimental Treatment1 Intervention

All patients who participate in the study will be recruited to the Intervention Arm and will undergo the STREAM program, a 24-week weight loss program which includes meal replacement, dietician teaching and regular appointments with their bariatric medicine specialist.

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