Life Study: Lifestyle Intervention in Fibroid Elimination

Sponsor

NYU Langone Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05416424

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroid	Other: LIFE program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

May 16, 2023

Anticipated Study Completion Date :

Feb 16, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Taraneh Shirazian, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT05416424

Other Study ID Numbers:

22-00226

First Posted:

Jun 13, 2022

Last Update Posted:

Jun 14, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Jun 14, 2022