Uterine Fibroid
Conditions
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.
Interventions
OTHERLIFE 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
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of LIFE program as measured by Self report survey | 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). |
| Change in improvement in quality of life as measured by Quality of Life Scale (QOLS) | 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. |
| Change in fibroid recurrence as measured by standard of care ultrasounds | Baseline, 6 month, 12 month | Adherence to a lifestyle program changes rate of fibroid recurrence as assessed by standard of care pelvic ultrasound results. |
Countries
United States
Outcome results
None listed