Life Study: Lifestyle Intervention in Fibroid Elimination

Not Applicable

Active, not recruiting

• Conditions: Uterine Fibroid
• Interventions: Other: LIFE program

• Registration Number: NCT05416424
• Lead Sponsor: NYU Langone Health

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.

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 Timeline

• Study Start: 2022-05-23
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Primary Completion: 2024-08-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	LIFE program	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.

Primary Outcome Measures

Name	Time	Method
Change in fibroid recurrence as measured by standard of care ultrasounds	Baseline, 6 month, 12 month	Adherence to a lifestyle program changes rate of fibroid recurrence as assessed by standard of care pelvic ultrasound results.
Acceptability of LIFE program as measured by Self report survey	12 month visit.	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).
Change in improvement in quality of life as measured by Quality of Life Scale (QOLS)	Baseline, 6 month, 12 month	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States