Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer

NCT04763902 | Completed Results

• 2 other identifiers: 127142UL1TR002538
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of this study is to determine the efficacy of time restricted eating (TRE) for improving metabolic health and preventing endometrial cancer. The primary objective of the protocol is to conduct a 14-week two-arm randomized crossover trial of a dietary intervention to evaluate the feasibility, fidelity and preliminary acceptability of a TRE intervention among Native Hawaiian/Pacific Islander women at risk for developing endometrial cancer, and to provide proof of principle that TRE can improve metabolic health in this population.

Conditions

Endometrial Neoplasms

Keywords

diet; time restricted eating (TRE); Native Hawaiian or other Pacific Islander; endometrial cancer risk; randomized crossover trial

Outcome Measures

Primary Outcomes (6)

• Proportion of Participants Referred That Were Consented and Enrolled

  The feasibility of the Time-Restricted Eating (TRE) intervention will be measured by calculating the proportion (%) of women who were consented and enrolled in the study out of all the participants who screened for the trial.

  up to 1 day after screening

• Attrition

  To assess the feasibility of the TRE intervention. This outcome measure will report the number of participants who withdrew throughout the course of the interventional component of the study.

  From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks

• Protocol Items Completed

  This outcome measure will report the count of participants who completed each study assessment per protocol. Participants who were randomized and withdrew from the study are included as missed assessments. After the TRE Schedule (Visit 3 or 5), waist circumference, weight, blood pressure, blood, and stool were collected. After the Control Schedule (Visit 3 or 5), waist circumference, weight, blood pressure, blood, and stool were collected. This outcome measure will report the count of participants who completed each assessment

  From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks

• Percentage of TRE-Adherent Days

  This outcome measure will report the mean percentage of TRE-adherent days. TRE adherence is achieved when participants fast for 14-18 hours per day during the TRE phase, as measured by a mealtime log using the MyCircadianClock phone app.

  From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks

• Meals Delivered On Schedule

  Count of participants whose pre-made control diet meals were delivered on schedule. Participants were provided with pre-made, frozen lunch and dinner meals 7 days a week during both 4-week diet phases.

  From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks

• Study Visit Completion

  To assess feasibility of the study, the percentage of in-person study visits completed out of 5 study visits for each participant was calculated. This outcome measure will report the mean percentage of completed study visits. This outcome measure was assessed throughout the course of the study during both the TRE and Control Schedules; it is not possible to regroup participants to report Arms/Groups "per intervention".

  From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks

Secondary Outcomes (8)

• Blood Pressure Measured With Electronic Blood Pressure Monitor

  From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks

• Waist Circumference

  From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks

• Body Mass Index (BMI) Assessed Via Stadiometer and Calibrated Scales

  From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks

• Fasting Blood Glucose Level

  From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks

• Fasting Blood C-peptide Level

  From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks

Study Arms (2)

Time Restricted Eating (TRE) Schedule, Then Control

EXPERIMENTAL

In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods), a 4-week washout period, and a 4-week control diet schedule.

Behavioral: Time Restricted Eating (TRE) Schedule; Behavioral: Control Schedule

Control Schedule, Then TRE

EXPERIMENTAL

In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by 4-week control diet schedule, a 4-week washout period, and an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods)

Behavioral: Time Restricted Eating (TRE) Schedule; Behavioral: Control Schedule

Interventions

Time Restricted Eating (TRE) Schedule BEHAVIORAL

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. They will be asked to maintain their regular sleep and physical activity schedule. Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day). Women will be asked to schedule the feeding period at the same time each day. They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing \< 4 kcal/serving) to increase compliance. All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.

Control Schedule, Then TRE; Time Restricted Eating (TRE) Schedule, Then Control

Control Schedule BEHAVIORAL

Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu will be designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.

Control Schedule, Then TRE; Time Restricted Eating (TRE) Schedule, Then Control

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Aims:
• Native Hawaiian/Pacific Islander females aged 18 years or older
• Overweight or obese (BMI\>25kg/m2) OR have a history of non-insulin dependent diabetes OR have a history of complex atypical endometrial hyperplasia
• Have a working cell phone that can download an App
• Able to use cell phone during day (e.g. at work)
• Not a night shift worker
• Applicable Only to Aims 2 \& 3:
• Able to attend study visits at the Huntsman Cancer Institute Center for HOPE

You may not qualify if:

• All Aims:
• Unable to provide informed consent
• Applicable Only to Aims 2 \& 3:
• Necessity of a special diet that precludes adjustment of meal timing and/or macronutrient content
• Have a history of insulin dependent diabetes
• Have a history of hysterectomy

Sponsors & Collaborators

• University of Utah: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Playdon M, Rogers TN, Brooks E, Petersen EM, Tavake-Pasi F, Lopez JA, Quintana X, Aitaoto N, Rogers CR. Sociocultural influences on dietary behavior and meal timing among Native Hawaiian and Pacific Islander women at risk of endometrial cancer: a qualitative investigation. Cancer Causes Control. 2023 Jan;34(1):23-37. doi: 10.1007/s10552-022-01628-0. Epub 2022 Oct 8.

  PMID: 36208351 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms; Intermittent Fasting

Interventions

Trehalase; Appointments and Schedules

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Disaccharidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Organization and Administration; Health Services Administration

Limitations and Caveats

Compliance with using the app was \~50%. TRE adherence therefore could only be evaluated among half of the study participants.

Results Point of Contact

• Title: Mary Playdon
• Organization: University of Utah

mary.playdon@hci.utah.edu

8012136264

Study Officials

• Mary Playdon, PhD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 21, 2021
• Study Start: February 18, 2021
• Primary Completion: June 10, 2022
• Study Completion: September 30, 2022
• Last Updated: July 29, 2026
• Results First Posted: July 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)