Clinical trial · Interventional
Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer
Feasibility and Acceptability of Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Schedule | Behavioral | — | UNRESOLVED |
| Time Restricted Eating (TRE) Schedule | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Time Restricted Eating (TRE) Schedule, Then Control
- description
- 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.
- interventionNames
- Behavioral: Time Restricted Eating (TRE) Schedule
- Behavioral: Control Schedule
- type
- EXPERIMENTAL
- label
- Control Schedule, Then TRE
- description
- 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)
- interventionNames
- Behavioral: Time Restricted Eating (TRE) Schedule
- Behavioral: Control Schedule
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPlaydon 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