Life Study: Lifestyle Intervention in Fibroid Elimination

NCT05416424 | Active Not Recruiting

• 1 other identifier: 22-00226
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

LIFE program OTHER

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

Study group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Taraneh Shirazian, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: May 23, 2022
• Primary Completion: August 20, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)