Weight Loss Program for PCOS and Obesity

(FLOWERS-PCOS Trial)

Overseen By Lesley Ananny, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: OCP, IUD, Weight drugs, Androgens

Disqualifiers: Bariatric surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a 24-week weight loss program for women with PCOS, a condition affecting hormone levels, who also face obesity challenges. The program, called STREAM, includes meal replacements, dietician guidance, and regular specialist check-ins. Researchers seek to determine the extent of weight loss and improvements in health, such as insulin sensitivity. Women who are not pregnant, have a BMI of 30 or higher, and are referred to a specific weight management clinic may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance weight management strategies for women with PCOS.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that impact weight, such as Liraglutide, Semaglutide, Tirzepatide, Naltrexone/Buproprion, and Orlistat, as well as androgen supplements like Testosterone and DHEAS. If you are currently using these, you would need to stop before participating.

What prior data suggests that the STREAM program is safe for participants?

Research has shown that intensive weight loss programs like STREAM are generally safe for people with PCOS (polycystic ovary syndrome). These programs emphasize lifestyle changes, such as meal replacements and guidance from dietitians, and are often the first recommended step for weight loss in women with obesity and PCOS. Studies have found these lifestyle changes to be well-tolerated, with no major safety concerns reported. Participants typically experience improvements in weight and other health measures without negative effects. Thus, the STREAM program is considered a safe option for managing weight and improving health related to PCOS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STREAM program for weight loss in individuals with PCOS and obesity because it combines several tailored approaches into one comprehensive plan. Unlike traditional treatments that might focus solely on diet or medication, the STREAM program integrates meal replacements, personalized dietician guidance, and regular check-ins with bariatric specialists over a 24-week period. This multifaceted approach aims to provide more sustainable weight loss by addressing both dietary habits and medical oversight, which could lead to better long-term health outcomes for participants.

What evidence suggests that the STREAM program might be an effective treatment for PCOS?

Research has shown that losing weight can improve key symptoms of PCOS, such as hormone balance and regular periods. One study found that participants lost between 2.32 and 7.87 kilograms over a year, depending on the type of support they received. Another review found that weight loss programs can enhance how the body uses blood sugar in individuals with PCOS. These findings suggest that the STREAM weight loss program, which all participants in this trial will undergo, might help people with PCOS lose weight and improve their overall health. ^{1 2 5 6 7}

Who Is on the Research Team?

Judy Shiau, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English proficiency

I have been referred to the LEAF Weight Management Clinic.

My BMI is 30 or higher, or it's 27 or higher with weight-related health issues.

Exclusion Criteria

Currently pregnant

I have had weight loss surgery in the past.

Currently on OCP or using an IUD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 24-week intensive weight loss program (STREAM) including meal replacement, dietician group coaching, and weekly meetings with a weight-loss specialist physician.

24 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood tests and quality of life assessments at 6 months post-treatment.

28 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• STREAM program

Trial Overview 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.

How Is the Trial Designed?

Group I: STREAM Weight-loss Program Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

LEAF Weight Loss Clinic

Collaborator

Trials

2

Recruited

80+

Published Research Related to This Trial

In a study of 27 obese patients with PCOS who did not respond to lifestyle modifications, treatment with semaglutide led to an average weight loss of 7.6 kg after three months, with 80% of participants achieving at least a 5% reduction in body weight.

Semaglutide treatment not only resulted in significant weight loss but also improved insulin sensitivity and normalized menstrual cycles in 80% of responsive patients, all with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Treatment of Excessive Body Weight in Obese PCOS Patients Unresponsive to Lifestyle Programs. Carmina, E., Longo, RA.[2023]

Citations

1. acpjournals.org acpjournals.org/doi/10.7326/M23-3179

Effect of Weight Loss Interventions on the Symptomatic ... For women with PCOS, our systematic review suggests weight loss interventions led to improvements in some important clinical features of PCOS.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1056872724001600

The efficacy and safety of GLP-1 agonists in PCOS women ... This study provides evidence that GLP1 receptor agonists are a safe and effective adjunct treatment for weight reduction in women with PCOS.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06325449?intr=%22Weight%20Reduction%20Programs%22&aggFilters=status:not%20rec&rank=5

Correlating Improvement in PCOS Symptoms to the ... The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9541741/

How to manage weight loss in women with obesity and ... At 12 months, the mean weight loss was 2.32 (2.6%), 4.65 (5.1%) and 7.87 kg (8.1%) in the routine care, LBI without SMS and with SMS, respectively (within all ...

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70116

Pre‐conception weight loss interventions in women with ... A randomized trial of the effects of two types of short-term hypocaloric diets on weight loss in women with polycystic ovary syndrome.

6. asrm.org asrm.org/practice-guidance/practice-committee-documents/recommendations-from-the-2023-international-evidence-based-guideline-for-the-assessment-and-management-of-polycystic-ovary-syndrome/

Recommendations from the 2023 International Evidence ... What is the recommended assessment and management of those with polycystic ovary syndrome (PCOS).

7. tandfonline.com tandfonline.com/doi/full/10.1080/17446651.2025.2554668

Reframing polycystic ovary syndrome as a complication of ... Reproductive safety endpoints should include placental transmission, transplacental receptor expression, and downstream consequences for fetal growth, glucose ...