Life Study: Lifestyle Intervention in Fibroid Elimination

NYU Langone Health

Status: Active, not recruiting

Conditions: Uterine Fibroid

Treatments: Other: LIFE program

Study type: Interventional

Funder types: Other

Identifiers

NCT05416424

22-00226

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Study group

Experimental group

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.

Treatment:

Other: LIFE program