NCT04783467

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 7, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

February 18, 2021

Last Update Submit

November 28, 2023

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (5)

  • Proportion of Women Referred that are Consented

    Feasibility of the TRE intervention will be measured be calculating the proportion (%) of women who were referred that were consented into the study. The study will be considered feasible of \> 70% of participants are consented and retained.

    From baseline to Visit 5 (Week 16)

  • Attrition as a Function of Time

    Number of participants who withdraw throughout the course of the study.

    From baseline to Visit 5 (Week 16)

  • Percent of Scheduled Assessments Completed

    Feasibility of the TRE intervention will be assessed by calculating a percentage of scheduled biospecimen collection and questionnaires completed.

    From baseline to Visit 5 (Week 16)

  • Number of TRE-Adherent Days per Week

    Feasibility of the TRE intervention will be measured by calculating the number of TRE-adherent days per week. Participants will be considered adherent if they fasted between 14-16 hours per day during the TRE phase according to the MCC App mealtime log. The study will be considered feasible if women adhere to the TRE protocol on average 5 days per week.

    From baseline to Visit 5 (Week 16)

  • Fidelity of Time Restricted Eating (TRE) Intervention

    Fidelity will be evaluated as a percentage of protocol checklist items delivered as intended with a goal of 90%

    From baseline to Visit 5 (Week 16)

Secondary Outcomes (9)

  • Change in blood pressure assessed via electronic blood pressure monitor

    Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16)

  • Change in waist circumference assessed via measuring tape

    Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16)

  • Change in BMI assessed via height and weight

    Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16)

  • Change in fasting blood glucose assessed via blood draw

    Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16)

  • Change in HOMA-IR assessed via blood draw

    Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16)

  • +4 more secondary outcomes

Study Arms (2)

Time Restricted Eating (TRE) Schedule

EXPERIMENTAL

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.

Behavioral: Time Restricted Eating (TRE) Schedule

Control Schedule

NO 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.

Interventions

Time Restricted Eating (TRE) ScheduleBEHAVIORAL

\[See arm/group descriptions\]

Time Restricted Eating (TRE) Schedule

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (1)

  • Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.

    PMID: 36971688DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

TrehalaseAppointments and Schedules

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

DisaccharidasesGlycoside HydrolasesHydrolasesEnzymesEnzymes and CoenzymesOrganization and AdministrationHealth Services Administration

Study Officials

  • Mary Playdon, PhD, MPH

    University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Playdon, PhD, MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Investigator

Study Record Dates

First Submitted

February 18, 2021

First Posted

March 5, 2021

Study Start

October 7, 2021

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

US(1)