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

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

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Neoplasms
• Intervention / Treatment: Behavioral: Time Restricted Eating (TRE) Schedule; Behavioral: Control Schedule

Detailed Description

Enrollment: The study includes two phases. Phase 1 includes focus groups among 30 Native Hawaiian/Pacific Islander women at risk of endometrial cancer. Focus groups will determine sociocultural influences on (i) dietary behavior including meal timing; (ii) dietary preferences; (iii) proposed meal plans and intervention design; (iv) perceptions of weight loss and body image. In the second study phase, the study team will recruit 10 Pacific Islander women to participate in a 14-week randomized dietary crossover study. Each woman will participate in both intervention arms and act as her own control.

Focus Group: To accomplish all aspects of Aim 1 of this study, the study team will recruit 30 Pacific Islander women at risk for endometrial cancer to conduct virtual focus groups. These focus groups will take place via private videoconference, like Zoom, and a language translator will be provided, as necessary. The focus groups will be attended by a Native Hawaiian/Pacific Islander Community Expert. Questions will be designed to understand sociocultural influences on dietary behavior (questions on social eating, meal timing, and dietary preferences, soliciting feedback on study intervention delivery design, and perceptions of weight loss and body image). An icebreaker will be conducted prior to formal questioning. Sessions will be audio-recorded on the videoconference and an additional device, transcribed verbatim, and checked for accuracy. Two additional team members will be present as note takers. Our Community Expert will be present to help facilitate the session. Questions will be provided at the beginning of the session to ensure cultural sensitivity.

Dietary Intervention: The dietary intervention includes 5 study visits, and features a baseline visit, 2-week run-in period, 4-week control diet schedule, 4-week washout period, and a 4-week, 8 to 10-hour Time Restricted Eating (TRE) protocol (8 to 10-hour feeding and 14 to 16-hour fasting periods). A follow-up questionnaire will be mailed 6-months post- intervention. For the control schedule, women will receive frozen lunch and dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu will be designed to be culturally competent with feedback from the focus groups, and meal plans will be individualized to meet weight maintenance energy requirements. For the TRE schedule, 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. The fasting period will ramp up during the first week (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 eating period at the same time each day. All meals (control and TRE) will be provided by the Metabolic Kitchen located at the University of Utah.

Visit 1: During the baseline visit, a coordinator will obtain consent from the participant, and they will be asked to compete questionnaires asking about clinical and demographic factors, chronotype, and physical activity, and various anthropometric measurements will be taken. Following the baseline visit, participants will undergo a 2-week run-in period. During this time, the goal is to record women's usual times of eating episodes and appetite while following their habitual diet.

Visit 2: Women will provide fasting blood and stool samples, and anthropometric measurements will be taken. Following visit 2, participants will undergo the control or TRE schedule for 4 weeks.

Visit 3: After 4 weeks, participants will undergo visit 3 and will be asked to provide fasting blood and stool samples, and anthropometric measures will be taken. Following visit 3, participants will undergo a 4-week washout period, where women are able to return to their usual lifestyle.

Visit 4: Visit 4 will occur after the 4-week washout period, and will include a telephone consultation to discuss the next study phase and schedule meal provision. For the following 4-weeks, participants will then undergo the opposite feeding schedule (either control or TRE).

Visit 5: During the final visit, women will provide fasting blood and stool samples, and anthropometric measures will be taken.

During the run-in period, the TRE phase and the control phase, participants will record timing of eating episodes using the MyCircadian Clock phone app, complete 3 x 24-hour diet recalls, a single physical activity recall, and 7-days of sleep and physical activity will be objectively measured using an Actiwatch device. Hunger and satiety will be evaluated at random through the MyCircadian Clock phone app.

A study exit interview will be conducted via Zoom conference call to debrief on the intervention and obtain detailed information on acceptability of the protocol. Approximately 6-months after the end of the intervention period, women will complete a mailed follow-up questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time Restricted Eating (TRE) Schedule, Then Control; 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; 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.; Behavioral: Control Schedule; 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.
Experimental: Control Schedule, Then TRE; 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; 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.; Behavioral: Control Schedule; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Measured With Electronic Blood Pressure Monitor	Blood pressure was measured using an electronic blood pressure monitor after the TRE phase and after the control diet phase.	From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Waist Circumference	Waist circumference was measured by trained study staff using a tape measure and standardized protocols. Waist circumference was measured after the TRE Schedule and after the Control Schedule.	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	Participants' height and weight was measured by trained study staff using a stadiometer and calibrated weighing scales. Measures were done in triplicate (duplicate if measures did not agree). Height and weight were used to calculate body mass index in kilograms divided by height in meters-squared. BMI was measured after the TRE Schedule and after the Control Schedule.	From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Fasting Blood Glucose Level	Fasting glucose was measured at Associated Regional and University Pathologists (ARUP) Laboratories. Fasting blood samples were taken from participants by a trained phlebotomist using standard protocols after the TRE Schedule and after the Control Schedule.	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	C-peptide was measured at ARUP Laboratories. Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.	From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Fasting Blood Triglyceride Level	Blood triglyceride level was measured at ARUP Laboratories. Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.	From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Fasting Blood High-density Lipoprotein(HDL)-Cholesterol Level	Blood HDL-cholesterol level was measured at ARUP Laboratories. Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.	From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Fasting Blood High Sensitivity C-reactive Protein	Blood C-peptide level was measured at ARUP Laboratories. Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.	From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Mary Playdon, PhD, MPH, University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: diet; randomized crossover trial; time restricted eating (TRE); Native Hawaiian or other Pacific Islander; endometrial cancer risk
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Behavior; Feeding Behavior; Fasting; Endometrial Neoplasms; Intermittent Fasting; Organization and Administration; Health Services Administration; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Disaccharidases; Appointments and Schedules; Trehalase
• Other Study ID Numbers: 127142; UL1TR002538 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No