NCT05416424

Life Study: Lifestyle Intervention in Fibroid Elimination

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Uterine Fibroid

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-23
• Primary completion: 2024-08-20
• Completion: 2027-01-01
• First posted: 2022-06-13
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States