Lifestyle Intervention for Uterine Fibroids

Overseen By Taraneh Shirazian, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Hormonal, GNRH agonists

Disqualifiers: Pregnancy, Postmenopausal, GI disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program focused on lifestyle, nutrition, and exercise to determine if it can help prevent the return of uterine fibroids (non-cancerous growths in the uterus). Researchers aim to assess whether patients find this program, known as the LIFE program, easy to follow and beneficial. It targets women who have recently undergone surgery or a procedure to remove fibroids and are currently not experiencing fibroids. Participants should have visited their primary care doctor and completed lab tests within the past three months. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance post-surgical care for women with fibroids.

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

The trial excludes participants using medications that affect fibroid growth, like hormonal or GNRH agonists. If you're on such medications, you may need to stop them to participate.

Will I have to stop taking my current medications?

The trial excludes participants using medications that affect fibroid growth, so you may need to stop such medications to join. However, the protocol does not specify about other medications.

What prior data suggests that this lifestyle program is safe for patients with uterine fibroids?

Research has shown that the LIFE program, which emphasizes lifestyle, nutrition, and exercise, is safe for people with uterine fibroids. Studies have found that this program can ease symptoms and improve quality of life for up to a year after fibroid treatment. Participants reported feeling better without any serious side effects.

In simpler terms, the LIFE program is gentle on the body. It offers a natural way to manage symptoms, focusing on healthy living without risky medications. This makes it a safe choice for those looking to boost their health after fibroid treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LIFE program for uterine fibroids because it takes a holistic approach, focusing on lifestyle interventions rather than traditional medical or surgical treatments. Unlike current options like medication (e.g., hormonal therapies) or surgical procedures (like myomectomy or hysterectomy), the LIFE program emphasizes managing symptoms through diet, exercise, and stress reduction. This approach could potentially reduce reliance on medication and invasive procedures, offering a more natural way to manage fibroid symptoms with fewer side effects. By promoting overall wellness, the LIFE program aims to improve quality of life for women dealing with fibroids over the long term.

What evidence suggests that the LIFE program might be an effective treatment for uterine fibroids?

Research has shown that the LIFE program, which involves changes in diet, nutrition, and exercise, may help manage uterine fibroids. Studies have found that this program can reduce fibroid symptoms and improve quality of life for up to a year after treatment. Another study on a similar lifestyle change also demonstrated improvements in symptoms and overall well-being. Designed to be easy and practical for patients, the program offers a good option for managing fibroid symptoms. Overall, these findings suggest that the LIFE program could effectively lessen the impact of uterine fibroids. ^{1 2 3 4 6}

Who Is on the Research Team?

Taraneh Shirazian, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 18-50 who have recently had fibroid removal surgery at the Center for Fibroid Care at NYU and are now 'fibroid free.' They must have seen their primary care physician in the last three months. Women on certain medications, outside the post-surgery window, postmenopausal, unable to exercise, with dietary restrictions due to GI disorders, or who are pregnant cannot join.

Inclusion Criteria

I had surgery to remove fibroids within the last 3 months and am now considered 'fibroid free.'

Visit with PCP within the last 3 months with labs

I can speak, read, and write in English.

Exclusion Criteria

I am not on medications that could affect fibroid growth.

I am a woman who has gone through menopause.

Currently Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-surgical Enrollment

Participants are enrolled into a lifestyle, nutrition, supplement, and exercise program post-surgery

1 month

1 visit (in-person)

Lifestyle Intervention

Participants follow the LIFE program to assess its feasibility and impact on fibroid recurrence

12 months

Surveys collected at 3-6 month intervals

Follow-up

Participants are monitored for changes in fibroid recurrence and quality of life

12 months

Visits at baseline, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• LIFE program

Trial Overview The LIFE Study is testing a lifestyle intervention program focused on nutrition and exercise. It aims to see if this program can prevent fibroids from coming back by making it part of patients' daily lives. The study will check how well participants accept and stick to this program.

How Is the Trial Designed?

Group I: Study group Experimental Treatment 1 Intervention

Healthy patients aged 18-50 who have a uterus, identify as female and have come to the outpatient Center for Women's Health (CWH) for management of bleeding, pelvic pain and fibroids. They will be offered enrollment post-surgery or procedure and will be followed longitudinally for 12 months.

LIFE program is already approved in United States for the following indications:

Approved in United States as LIFE Program for:

• Prevention of fibroid recurrence
• Management of uterine fibroids

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Lifestyle interventions, including calorie restriction and exercise, are beneficial for improving metabolic syndrome features and surrogate markers of non-alcoholic fatty liver disease (NAFLD), which affects about one-third of the Western population.

There is a lack of long-term studies (most under 12 months) and histological evidence to conclusively demonstrate the effectiveness of these interventions on the actual liver tissue, indicating a need for further research with extended follow-up periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions for the treatment of non-alcoholic fatty liver disease. Bradford, V., Dillon, J., Miller, M.[2021]

A community-based lifestyle modification program significantly improved remission rates of non-alcoholic fatty liver disease (NAFLD), with 64% of participants achieving remission compared to only 20% in the control group after 12 months.

Participants in the intervention group experienced a mean reduction in liver fat of 6.7% and a weight loss of 5.6 kg, demonstrating that even modest weight loss (3-4.9%) can lead to remission in some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based lifestyle modification programme for non-alcoholic fatty liver disease: a randomized controlled trial. Wong, VW., Chan, RS., Wong, GL., et al.[2022]

A 10-week diet plus exercise program significantly improved liver health and overall fitness in patients with nonalcoholic fatty liver disease (NAFLD), showing better results than exercise alone.

While both diet-plus-exercise and exercise-only programs improved health markers like body weight and insulin sensitivity, only the diet-plus-exercise group showed significant improvements in liver biochemistry, highlighting its greater efficacy in treating NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of therapeutic lifestyle program on ultrasound-diagnosed nonalcoholic fatty liver disease. Chen, SM., Liu, CY., Li, SR., et al.[2022]

In a study of 116 premenopausal women with uterine leiomyomas, symptoms like pain and bleeding were the main factors influencing the decision to choose surgical intervention, rather than the number or size of the fibroids.

Both black and white women opted for treatment at similar rates (44% and 40%, respectively) when experiencing significant symptoms, indicating that effective management of these symptoms could potentially reduce the need for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fibroid growth study: determinants of therapeutic intervention. Davis, BJ., Haneke, KE., Miner, K., et al.[2021]

Women with uterine fibroids have a significantly higher risk of developing hypertension, with an odds ratio of 3.4 compared to controls, indicating a strong association between fibroids and high blood pressure.

The study found that 66.7% of women with fibroids showed signs of asymptomatic organ damage, particularly affecting younger women, highlighting the potential long-term health risks associated with fibroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The risk of hypertension and cardiovascular disease in women with uterine fibroids. Haan, YC., Diemer, FS., Van Der Woude, L., et al.[2021]

The novel uterine fibroid treatment device demonstrated a significant reduction in fibroid volume, with a mean decrease of 36.3% at 3 months and 60.4% at 12 months, indicating its efficacy in treating uterine fibroids.

The study involved 16 symptomatic pre-menopausal black women and showed no serious adverse events or unanticipated risks, suggesting that the device is safe for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids. Tal, MG., Keidar, R., Magnazi, G., et al.[2023]

Uterine fibroids (UF) significantly impact health-related quality of life (HRQOL) and work productivity among women in Western Europe, with a mean productivity reduction of 36.1% and general activity impairment of 37.9%.

Many women delay seeking treatment for UF, with 9.0% to 32.5% waiting over five years, indicating a need for increased awareness and encouragement to seek medical help earlier to improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The burden of uterine fibroids in five European countries. Downes, E., Sikirica, V., Gilabert-Estelles, J., et al.[2022]

There is currently no single validated treatment for non-alcoholic fatty liver disease (NAFLD), as its multifactorial nature requires addressing various risk factors through participatory interventions and lifestyle changes.

Participatory medicine, which emphasizes awareness and education about NAFLD, can lead to better prevention and management strategies, utilizing non-invasive imaging and training for healthcare professionals to promote healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

4Ps medicine of the fatty liver: the research model of predictive, preventive, personalized and participatory medicine-recommendations for facing obesity, fatty liver and fibrosis epidemics. Trovato, FM., Catalano, D., Musumeci, G., et al.[2020]

African-American women have the highest risk of developing surgically confirmed fibroids compared to non-Latina white women, highlighting the importance of race in understanding fibroid prevalence.

Postmenopausal women have a lower risk of fibroids than premenopausal women, but hormone replacement therapy increases the risk, suggesting that reproductive factors and hormone treatments play a significant role in fibroid development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for surgically removed fibroids in a large cohort of teachers. Templeman, C., Marshall, SF., Clarke, CA., et al.[2021]

Lifestyle modifications, such as diet and exercise, are crucial for treating non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), but current clinical trials lack a systematic approach to evaluate their impact on treatment outcomes.

The review highlights the need for better methods to assess lifestyle changes in clinical trials, aiming to improve the understanding of how these modifications can influence disease activity and enhance the interpretation of trial results across different phases of research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum. Glass, O., Filozof, C., Noureddin, M., et al.[2023]

7.7% of women aged 18-54 in the US reported being diagnosed with uterine fibroids, with prevalence increasing with age and being higher in black women (9.8%) compared to white women (5.4%).

Women with uterine fibroids experienced significantly more severe symptoms, such as heavy menstrual bleeding (16.7% vs 7.7% in those without fibroids) and pelvic pressure (1.6% vs 0.6%), indicating a substantial symptom burden associated with the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported prevalence and symptomatic burden of uterine fibroids among women in the United States: findings from a cross-sectional survey analysis. Fuldeore, MJ., Soliman, AM.[2020]

A survey of 1287 French women revealed that 64% of those with symptomatic uterine fibroids reported a moderate to severe impact on their quality of life, indicating significant health-related concerns.

Women with symptomatic fibroids had lower overall well-being scores (6.6 out of 10) compared to those without fibroids (7.3 out of 10), highlighting the substantial discomfort and emotional distress associated with these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of uterine fibroids on quality of life: a national cross-sectional survey. Hervé, F., Katty, A., Isabelle, Q., et al.[2019]

A systematic review of 52 studies on medical therapies for fibroids highlights the need for uterine-sparing treatments that preserve fertility and avoid surgery, addressing patient demands.

The review identified multiple effective agents that could serve as promising alternatives to surgical options for treating fibroids, indicating potential advancements in medical management of this common condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evidence-based Approach to the Medical Management of Fibroids: A Systematic Review. Bartels, CB., Cayton, KC., Chuong, FS., et al.[2018]

In a survey of 2498 women aged 30 to 55 in France, 8.8% reported having symptomatic uterine fibroids, with the majority experiencing bleeding and pain, significantly affecting their quality of life.

Many women (34.9%) experienced symptoms for an average of 2.22 years before receiving a diagnosis, highlighting a delay in treatment and the need for better awareness and management of uterine fibroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevalence of uterine fibroids in France and impact on quality of life: results of a survey among 2500 women between 30-55 years]. Fernandez, H., Chabbert Buffet, N., Allouche, S.[2015]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05416424/life-study-lifestyle-intervention-in-fibroid-elimination

Life Study: Lifestyle Intervention in Fibroid Elimination The study will evaluate a lifestyle, nutrition, and exercise program to assess whether this program is acceptable and feasible for patients.

2. journals.lww.com journals.lww.com/greenjournal/abstract/2025/06001/effects_of_a_lifestyle_intervention_on.97.aspx

Effects of a Lifestyle Intervention on Fibroid-Related... The objective of this study was to evaluate the effects of a 12-month exercise and nutrition intervention on quality of life (QOL), symptom severity (SS), ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10975324/

Empowering Strategies for Lifestyle Interventions, Diet ... Association of health and lifestyle factors with uterine fibroids among Saudi women: A case-control study. J. Taibah Univ. Med. Sci. 2022;17 ...

4. mdpi.com mdpi.com/2077-0383/14/20/7140

Nutrition and Uterine Fibroids: Clinical Impact and ... Can a Diet, Nutrition and Supplement Program Prevent Uterine Fibroid Recurrence? Pilot Results of the LIFE Program. Reprod. Sci. 2025, 32, 2216–2222 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40542307/

Can a Diet, Nutrition and Supplement Program Prevent ... The LIFE Program was associated with a reduction in symptom burden and an improvement in quality of life up to 12 months after a procedural fibroid ...

6. researchgate.net researchgate.net/publication/392890224_Can_a_Diet_Nutrition_and_Supplement_Program_Prevent_Uterine_Fibroid_Recurrence_Pilot_Results_of_the_LIFE_Program

Can a Diet, Nutrition and Supplement Program Prevent ... The LIFE Program was associated with a reduction in symptom burden and an improvement in quality of life up to 12 months after a procedural fibroid intervention ...