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Active, Not Recruiting

NCT Number: NCT05416424

Life Study: Lifestyle Intervention in Fibroid Elimination

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Uterine Fibroid Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Jun 13, 2022
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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