Actively Recruiting
UPLifT-Endo: Uterine Preservation Via Lifestyle Transformation A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Atypical Endometrial Hyperplasia or Grade 1 Endometrial Cancer
Led by Washington University School of Medicine · Updated on 2026-01-20
96
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying premenopausal women with obesity who have atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer. The study aims to compare the effectiveness of progestin treatment combined with a behavioral weight loss program versus progestin treatment with enhanced usual care. This approach is designed to improve uterine preservation and reduce the risk of developing or relapsing endometrial cancer, especially since obesity is a key underlying cause. Participants receive a levonorgestrel-releasing intrauterine device (IUD) that delivers progestin, which is standard care for this condition. One group will also take part in a telemedicine cognitive behavioral coaching program focused on weight loss, including tracking diet and exercise. The other group will receive educational handouts about healthy eating and exercise. Those in the usual care group who do not achieve disease resolution after 12 months may switch to the behavioral weight loss program. During the study, participants will regularly report weight, diet, and exercise activity. Researchers will monitor biopsy results to check for disease resolution at one year and track outcomes such as time to resolution of AEH or cancer, weight changes, and cancer worry scores over two years. The study involves random assignment to groups and does not use blinding. Participation may last up to two years with ongoing follow-up to evaluate treatment effects and uterine health.
CONDITIONS
Brief Title
Uterine Preservation Via Lifestyle Transformation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of histologically confirmed complex atypical endometrial hyperplasia or grade 1 endometrial cancer
- Premenopausal woman with a uterus
- Age between 18 and 45 years
- Body mass index (BMI) of 30 kg/m² or higher
- Undergoing uterine-sparing management
- ECOG performance status of 0-2
- Ability to understand and willing to sign informed consent
- Prior or current progestin treatment allowed with documentation
- Willingness to have a levonorgestrel-releasing IUD placed at study entry
You will not qualify if you...
- Current treatment with chemotherapy or radiation for any cancer
- Pregnant or breastfeeding; must have a negative pregnancy test before IUD insertion
- Active pelvic infection at the time of IUD placement or other physician-determined contraindications to IUD use
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive a levonorgestrel-releasing IUD as standard care and are randomized to either a telemedicine behavioral weight loss intervention or enhanced usual care handouts. The behavioral intervention includes weekly, biweekly, then monthly telephone coaching sessions over 12 months.
Weekly calls for 1 month, biweekly calls for 5 months, then monthly calls for 6 months
Duration - Additional treatment after 12 months as needed
Participants in the enhanced usual care arm who do not achieve resolution of atypical endometrial hyperplasia or grade 1 endometrial cancer at 12 months cross over to the behavioral weight loss intervention for additional treatment.
Follow-up as per behavioral intervention schedule
Duration - Up to 2 years
Participants are monitored for resolution of atypical endometrial hyperplasia or endometrial cancer and other outcomes for up to 2 years after treatment initiation.
Assessments at enrollment, 6 months, 12 months, end of intervention, and 24 months
Trial Site Locations
Total: 3 locations
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
2
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
3
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
A
Andrea R Hagemann, M.D., MSCI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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