Recruiting

Time Restricted Eating

Sponsor:

University of Utah

Code:

NCT04783467

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Time Restricted Eating (TRE) Schedule

Study Details

Brief summary:

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.

Conditions

Endometrial Cancer

Study ID

NCT04783467

Start date

Oct 7, 2021

Status verified date

Nov, 2023

Completion date

Jun, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Females aged 18 years or older
  • Diagnosed with endometrial cancer (any stage)
  • Clinically overweight or obese (BMI >= 25 kg/m2)
  • At least 3 months post-cancer surgery and/or treatment
  • Weight stable for 3 months prior to beginning the study (<4kg weight loss/gain)
  • Have a cell phone that is able to download a phone App and able to use phone during the day

Exclusion Criteria:

  • Persons with special dietary requirements
  • Unable to provide informed consent
  • Unable to read, write, or fill in questionnaires in English
  • Insulin dependent diabetes
  • Night shift workers
  • Persons not able to use cell phone during day (like for work)

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Time Restricted Eating (TRE) Schedule

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.

no intervention: Control Schedule

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.

Interventions

Time Restricted Eating (TRE) Schedule

\[See arm/group descriptions\]

Primary outcome measure

  • Proportion of Women Referred that are Consented [ Time Frame: From baseline to Visit 5 (Week 16) ]
  • Attrition as a Function of Time [ Time Frame: From baseline to Visit 5 (Week 16) ]
  • Percent of Scheduled Assessments Completed [ Time Frame: From baseline to Visit 5 (Week 16) ]
  • Number of TRE-Adherent Days per Week [ Time Frame: From baseline to Visit 5 (Week 16) ]
  • Fidelity of Time Restricted Eating (TRE) Intervention [ Time Frame: From baseline to Visit 5 (Week 16) ]

Central Contacts and Locations

Central contacts

Mary Playdon, PhD, MPH

(801) 213-6264mary.playdon@hci.utah.edu

Locations

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Mary Playdon, PhD, MPH

801-213-6264mary.playdon@hci.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Nov 30, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2023-11-30.