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Life Study: Lifestyle Intervention in Fibroid Elimination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05416424
Recruitment Status : Recruiting
First Posted : June 13, 2022
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Actual Study Start Date : May 23, 2022
Estimated Primary Completion Date : December 15, 2024
Estimated Study Completion Date : June 1, 2025
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Acceptability of LIFE program as measured by Self report survey [ Time Frame: 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).

  2. Change in improvement in quality of life as measured by Quality of Life Scale (QOLS) [ Time Frame: 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.

  3. Change in fibroid recurrence as measured by standard of care ultrasounds [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05416424


Contacts
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Contact: Taraneh Shirazian, MD 718-208-6442 Taraneh.shirazian@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Taraneh Shirazian, MD    718-208-6442    Taraneh.shirazian@nyulangone.org   
Principal Investigator: Taraneh Shirazian, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Taraneh Shirazian, MD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT05416424    
Other Study ID Numbers: 22-00226
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases