search
Back to results

Life Study: Lifestyle Intervention in Fibroid Elimination

Primary Purpose

Uterine Fibroid

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LIFE program
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uterine Fibroid

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2022
Last Updated
June 13, 2023
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05416424
Brief Title
Life Study: Lifestyle Intervention in Fibroid Elimination
Official Title
Effects of Implementing a Post-surgical Dietary and Lifestyle Protocol on Uterine Fibroid Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
LIFE program
Intervention Description
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
Primary Outcome Measure Information:
Title
Acceptability of LIFE program as measured by Self report survey
Description
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).
Time Frame
12 month visit.
Title
Change in improvement in quality of life as measured by Quality of Life Scale (QOLS)
Description
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.
Time Frame
Baseline, 6 month, 12 month
Title
Change in fibroid recurrence as measured by standard of care ultrasounds
Description
Adherence to a lifestyle program changes rate of fibroid recurrence as assessed by standard of care pelvic ultrasound results.
Time Frame
Baseline, 6 month, 12 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taraneh Shirazian, MD
Phone
718-208-6442
Email
Taraneh.shirazian@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taraneh Shirazian, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taraneh Shirazian, MD
Phone
718-208-6442
Email
Taraneh.shirazian@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Taraneh Shirazian, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Life Study: Lifestyle Intervention in Fibroid Elimination

We'll reach out to this number within 24 hrs