CompletedNot Applicable

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

United States39 participantsStarted 2021-02-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants Referred That Were Consented and Enrolled

Timeframe: up to 1 day after screening

Attrition

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

Protocol Items Completed

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

Percentage of TRE-Adherent Days

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

Meals Delivered On Schedule

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

Study Visit Completion

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

Trial details

NCT IDNCT04763902

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-10

Results submitted2024-04-09

View on ClinicalTrials.gov More Endometrial Neoplasms trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of Participants Referred That Were Consented and Enrolled

Timeframe: up to 1 day after screening

Attrition

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

Protocol Items Completed

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

Percentage of TRE-Adherent Days

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

Meals Delivered On Schedule

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

Study Visit Completion

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