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Behavioral Intervention

STREAM Weight-loss Program for Polycystic Ovary Syndrome (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

FLOWERS-PCOS Trial 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.Check my eligibility

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.See study design

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.

FLOWERS-PCOS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ep 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 scheduled pre-determined as weight loss isn't predictable.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ep 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 scheduled pre-determined as weight loss isn't predictable.

This trial's timeline: 3 weeks for screening, Varies for treatment, and ep 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 scheduled pre-determined as weight loss isn't predictable. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

FLOWERS-PCOS 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

LEAF Weight Loss ClinicUNKNOWN

1 Previous Clinical Trials

58 Total Patients Enrolled

Ottawa Hospital Research InstituteLead Sponsor

563 Previous Clinical Trials

2,787,697 Total Patients Enrolled

Judy Shiau, MDPrincipal InvestigatorThe Ottawa Hospital

1 Previous Clinical Trials

58 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being recruited for participation in this medical trial?

"As per the details on clinicaltrials.gov, this particular research endeavor is presently not in need of additional participants. It was initially listed on April 1st, 2024 and most recently updated on March 15th, 2024. Despite the cessation of recruitment for this specific study, it's noteworthy that there are currently 1207 other trials actively seeking eligible individuals to participate."

Answered by AI