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

NCT04763902 | Completed

• 2 other identifiers: IRB_00127142UL1TR002538
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrial Neoplasms

Outcome Measures

Primary Outcomes (6)

• 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.

  From baseline to Visit 5 (Week 14)

• Attrition as a Function of Time

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

  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.

  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.

  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.

  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%.

  From baseline to Visit 5 (Week 14)

Secondary Outcomes (9)

• Change in blood pressure assessed via electronic blood pressure monitor

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

• Change in waist circumference assessed via measuring tape

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

• Change in BMI assessed via height and weight

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

• Change in fasting blood glucose assessed via blood draw

  Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

• Change in HOMA-IR assessed via blood draw

  Visit 2 (Week 2), Visit 3 (Week 6), Visit 5 (Week 14)

Study Arms (2)

Time Restricted Eating (TRE) Schedule

EXPERIMENTAL

For 8 weeks out of the 14-week randomized dietary crossover study, women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calories-containing beverages within an 8 to 10-hour period that fits their 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).

Behavioral: Time Restricted Eating (TRE) Schedule

Control Schedule

NO INTERVENTION

For 4 weeks out of the 14-week randomized dietary crossover study, women will receive prepared frozen lunch and dinner meals, and a standardized breakfast and snacks menu. All meals and snacks will be culturally competent, and meal plans will be individualized to meet weight maintenance energy requirements.

Interventions

Time Restricted Eating (TRE) Schedule BEHAVIORAL

\[See arm/group descriptions\]

Time Restricted Eating (TRE) Schedule

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Trehalase; Appointments and Schedules

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Disaccharidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Organization and Administration; Health Services Administration

Study Officials

• Mary Playdon, PhD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Investigator

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 21, 2021
• Study Start: February 18, 2021
• Primary Completion: June 10, 2022
• Study Completion: September 30, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)