Time Restricted Eating for Endometrial Cancer (TREND Trial)

Palo Alto (17 mi)

Overseen byMary Playdon, PhD, MPH

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Recruiting

Sponsor: University of Utah

No Placebo Group

Trial Summary

What is the purpose of this trial?The long-term goal of this study is to determine the efficacy of Time Restricted Eating (TRE) for improving metabolic health, preventing cardiometabolic comorbidities, and improving prognosis after endometrial cancer diagnosis. The primary objective of the protocol is to conduct a 16-week randomized dietary crossover study to evaluate the feasibility, fidelity and preliminary acceptability of TRE among endometrial cancer patients, and to provide proof of principle that TRE can improve metabolic health in this population.

Eligibility Criteria

This trial is for women over 18 who've been diagnosed with endometrial cancer, are at least three months post-cancer surgery or treatment, and have had a stable weight recently. Participants must be clinically overweight or obese and able to use a cell phone app during the day. It's not for those unable to consent, read/write in English, on special diets, insulin-dependent diabetics, night shift workers, or restricted from using a cell phone.

Inclusion Criteria

I have been diagnosed with endometrial cancer.

I am a woman aged 18 or older.

Exclusion Criteria

I use insulin to manage my diabetes.

I am unable to understand and agree to the study's details on my own.

Treatment Details

The study is testing Time Restricted Eating (TRE) as a way to improve metabolic health after an endometrial cancer diagnosis. Over 16 weeks, participants will follow TRE schedules in a crossover design—meaning they'll switch between TRE and their usual eating pattern—to see if it's feasible and beneficial.

2Treatment groups

Experimental Treatment

Active Control

Group I: Time Restricted Eating (TRE) ScheduleExperimental Treatment1 Intervention

For 6-weeks out of the 16-week randomized dietary crossover study, women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule. The meal plans will be individualized to meet weight maintenance energy requirements.

Group II: Control ScheduleActive Control1 Intervention

For 4 weeks out of the 16-week randomized dietary crossover study, women will receive frozen lunch and dinner meals, and a standardized breakfast and snacks menu. The meal plans will be individualized to meet weight maintenance energy requirements. There are no restrictions on timing of eating.