Life Study: Lifestyle Intervention in Fibroid Elimination

Effects of Implementing a Post-surgical Dietary and Lifestyle Protocol on Uterine Fibroid Recurrence

The study will evaluate a lifestyle, nutrition, and exercise program to assess whether this program is acceptable and feasible for patients..Researchers will examine if the LIFE program can modify fibroid recurrence.

Study Overview

• Status: Active, not recruiting
• Conditions: Uterine Fibroid
• Intervention / Treatment: Other: LIFE program

Detailed Description

This prospective cohort pilot study will enroll asymptomatic, post-surgical patients who underwent a laparoscopic, open, robotic myomectomy, or other procedure ie Sonata, Accessa for fibroid removal. Patients will be offered enrollment into a lifestyle, nutrition, supplement, and exercise program to assess whether this program is acceptable and feasible for patients. Surveys will be collected at 3-6 month intervals.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants ages 18-50, who are seeking care at the Center for Fibroid Care at NYU
• Participants who have had a procedure or surgery performed to removed fibroids within the last 3 months and are now considered "fibroid free."
• Be English speaking and be able to read/write in English
• Visit with PCP within the last 3 months with labs

Exclusion Criteria:

• Currently Pregnant
• Use of any medication, hormonal or GNRH agonists, that would affect fibroid growth
• Postmenopausal women
• Non-English speaking
• Fibroid procedure or surgery outside of the 3-month window
• Women who are physically incapable of following a physical activity regimen
• Women with multiple dietary restrictions that would impact their ability to follow recommended dietary plan. (ie. GI disorders)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study group; 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.

Other: LIFE program; During the nutritionist visits, subjects will be asked to discuss and evaluate their current diet and will be given recommended dietary changes. The recommended dietary changes include focusing on eating nutrient dense foods, staying consistent with the timing of meals, limiting added sugars, aiming to have balanced meals and snacks, being a mindful eater, and aiming to drink approximately 2 liters of water a day. Additionally, they will review the nutrition survey with the registered dietician. During the office visits with a doctor, subjects will be given exercise counseling. They will be asked to do 150 minutes per week of moderate intensity aerobic activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of LIFE program as measured by Self report survey	Patient satisfaction survey will assess if patients found the program acceptable on a 5 point Likert scale ( not at all acceptable, fair, moderate, good excellent).	12 month visit.
Change in improvement in quality of life as measured by Quality of Life Scale (QOLS)	The Quality of Life Scale (QOLS) was originally a 15-item instrument that measured five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. Using a 7-point response scale, scores are summed so that a higher score indicates higher quality of life. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.	Baseline, 6 month, 12 month
Change in fibroid recurrence as measured by standard of care ultrasounds	Adherence to a lifestyle program changes rate of fibroid recurrence as assessed by standard of care pelvic ultrasound results.	Baseline, 6 month, 12 month

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Taraneh Shirazian, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): August 20, 2024
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: 22-00226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Taraneh.shirazian@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No