Endometrial NeoplasmsTIMESPANNCT04763902
Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer
A study testing Time Restricted Eating (TRE) Schedule in people with Endometrial Neoplasms, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Neoplasms
- What is being tested?
- Time Restricted Eating (TRE) Schedule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometrial Neoplasms
- Being tested
- Time Restricted Eating (TRE) Schedule, Control Schedule
- Keywords
- diet, time restricted eating (TRE), Native Hawaiian or other Pacific Islander, endometrial cancer risk, randomized crossover trial
- Medical subject headings
- Endometrial Neoplasms, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted Eating (TRE) ScheduleBehavioural
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 ScheduleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Behavioral: Time Restricted Eating (TRE) Schedule; Behavioral: Control Schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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
Blood pressure was measured using an electronic blood pressure monitor after the TRE phase and after the control diet phase.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start18 Feb 2021
- Primary completion10 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Mary Playdon, PhD, MPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763902
- Sponsor's protocol ID
- 127142
- Other IDs
- UL1TR002538
- Acronym
- TIMESPAN
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2021
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36208351
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04763902
- Acronym / sponsor ID
- TIMESPAN / 127142
- Conditions
- Endometrial Neoplasms
- Keywords
- diet, time restricted eating (TRE), Native Hawaiian or other Pacific Islander, endometrial cancer risk, randomized crossover trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 29 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating (TRE) Schedule, Then Control | Experimental | Behavioral: Time Restricted Eating (TRE) Schedule, Behavioral: Control ScheduleIn 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. |
| Control Schedule, Then TRE | Experimental | Behavioral: Time Restricted Eating (TRE) Schedule, Behavioral: Control ScheduleIn 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted Eating (TRE) ScheduleWomen 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. | Behavioural | Control Schedule, Then TRE, Time Restricted Eating (TRE) Schedule, Then Control |
| Control ScheduleWomen 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. | Behavioural | Control Schedule, Then TRE, Time Restricted Eating (TRE) Schedule, Then Control |
Primary outcome
Proportion of Participants Referred That Were Consented and Enrolled
Time frame: up to 1 day after screening
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.
Attrition
Time frame: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
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.
Protocol Items Completed
Time frame: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
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
Percentage of TRE-Adherent Days
Time frame: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
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.
Meals Delivered On Schedule
Time frame: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
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.
Study Visit Completion
Time frame: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
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".
8 secondary outcomes
Blood Pressure Measured With Electronic Blood Pressure Monitor
Time frame: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Waist Circumference
Time frame: 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
Time frame: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Fasting Blood Glucose Level
Time frame: 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
Time frame: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Fasting Blood Triglyceride Level
Time frame: 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
Time frame: 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
Time frame: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36208351Playdon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Playdon, PhD, MPH principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating (TRE) Schedule in people with Endometrial Neoplasms, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Referred That Were Consented and Enrolled (time frame: up to 1 day after screening). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.