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

NCT04763902CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

University of Utah

Enrollment

17

Start Date

2021-02-18

Completion Date

2022-06-10

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Time Restricted Eating (TRE) Schedule

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Proportion of Women Referred that are Consented

Feasibility of the TRE intervention will be measured by calculating a proportion (%) of women who were referred that were consented into the study. The study will be considered feasible if \> 70% of participants are consented and retained.

Time frame: From baseline to Visit 5 (Week 14)

Attrition as a Function of Time

Number of participants who withdraw throughout the course of the study.

Time frame: From baseline to Visit 5 (Week 14)

Percent of Scheduled Assessments Completed

Feasibility of the TRE intervention will be assessed by calculating a percentage of scheduled biospecimen collection and questionnaires completed.

Time frame: From baseline to Visit 5 (Week 14)

Number of TRE-Adherent Days per Week

Feasibility of the TRE intervention will be measured by calculating the number of TRE-adherent days per week. Participants will be considered adherent if they fasted between 14-18 hours per day during the TRE phase according to a mealtime log. The study will be considered feasible if women adhere to the TRE protocol on average 5 days per week.

Time frame: From baseline to Visit 5 (Week 14)

Percentage of Meals Delivered On Schedule

Feasibility of the TRE intervention will be measured by calculating a percentage of meals delivered on schedule.

Time frame: From baseline to Visit 5 (Week 14)

Fidelity of Time Restricted Eating (TRE) Intervention

Fidelity will be evaluated as a percentage of protocol checklist items delivered as intended with a goal of 90%.

Time frame: From baseline to Visit 5 (Week 14)

Secondary Outcomes

Change in blood pressure assessed via electronic blood pressure monitor

Blood pressure will be taken using an electronic blood pressure monitor.

Time frame: Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Change in waist circumference assessed via measuring tape

Waist circumference will be measured using a measuring tape.

Time frame: Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Change in BMI assessed via height and weight

Participants' height and weight will be taken and used to calculate BMI.

Time frame: Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Change in fasting blood glucose assessed via blood draw

A small sample of blood will be taken from participants at designated study visits.

Time frame: Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Change in HOMA-IR assessed via blood draw

A small sample of blood will be taken from participants at designated study visits.

Time frame: Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Change in c-peptide assessed via blood draw

A small sample of blood will be taken from participants at designated study visits.

Time frame: Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Change in triglycerides assessed via blood draw

A small sample of blood will be taken from participants at designated study visits.

Time frame: Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Change in HDL-cholesterol assessed via blood draw

A small sample of blood will be taken from participants at designated study visits.

Time frame: Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Change in high sensitivity C-reactive protein assessed via blood draw

A small sample of blood will be taken from participants at designated study visits.

Time frame: Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Locations

Huntsman Cancer Institute, Salt Lake City, United States

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