Brief Title
Time Restricted Eating (TRE) Among Endometrial Cancer Patients
Official Title
Feasibility and Acceptability of Time Restricted Eating (TRE) Among Endometrial Cancer Patients: the TREND Study
Brief Summary
The long-term goal of this study is to determine the efficacy of Time Restricted Eating (TRE)
for improving metabolic health, preventing cardiometabolic comorbidities, and improving
prognosis after endometrial cancer diagnosis. The primary objective of the protocol is to
conduct a 16-week randomized dietary crossover study to evaluate the feasibility, fidelity
and preliminary acceptability of TRE among endometrial cancer patients, and to provide proof
of principle that TRE can improve metabolic health in this population.
Detailed Description
Enrollment: The study team will aim to recruit 15 endometrial cancer patients seen at the
Huntsman Cancer Hospital Clinics. Consent may be completed via phone/email or in-person with
the study clinical coordinator.
Dietary Intervention: Participants who are consented into the study will participate in a
16-week randomized dietary crossover intervention. The dietary intervention includes 5 study
visits, and features a baseline visit, 2-week run-in period, 4-week control diet schedule
with prepared frozen meals provided to participants, 4-week washout period, and a 6-week, 8
to 10-hour Time Restricted Eating (TRE) protocol (meal provision with 8 to 10-hour eating and
14 to 16-hour fasting periods). Women will be randomized to either control or TRE, then
crossover to the other condition. For the control schedule, women will receive frozen lunch
and dinner meals and be provided with a standardized breakfast and snacks menu, and there are
no restrictions on timing of eating. 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. 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 eating
period at the same time each day.
Study Visits and Assessments: Women will attend in-person study visits at the Huntsman Cancer
Institute Center for Health Outcomes and Population Equity (HOPE).
- Baseline Visit (Visit 1): The clinical coordinator will obtain consent from the
participant. Once consented, women will complete questionnaires to capture information
on clinical and demographic factors, and chronotype. Height will be measured using
stadiometer, weight will be measured using calibrated scales, waist circumference with
measuring tape and blood pressure (BP) using an electronic BP monitor. Participants may
take home questionnaires, with mailer, to complete at home.
- 2-Week Run-In Period: The purpose of the run-in period is to record women's usual times
of eating episodes and appetite while following their habitual diet. Appetite will be
measured using the MyCircacianClock (mCC) phone app that has the capability to sample
subjects' current behaviors and experiences in real time in their natural environment.
Women will complete 3 x 24-hour dietary recalls on non-consecutive days (ASA-24) and a
physical activity recall (ACT24 available online or phone app, or via telephone
conference with the clinical coordinator). Sleep and activity will also be objectively
measured for 7-days using an Actiwatch.
- Visit 2: Women will provide fasting blood and stool samples. Weight, waist circumference
and blood pressure will be measured.
- Control OR TRE Schedules: The participants will be expected to follow their randomized
schedule for meal timing. During these schedules, for both study groups, participants
will record timing of eating episodes daily using the MyCircadianClock app, complete 3 x
24-hour recalls (ASA24), 1 x ACT24 activity recall, and 7-days of sleep/physical
activity will be objectively measured via Actiwatch.
- Visit 3: Women will provide fasting blood and stool samples. Weight, waist circumference
and blood pressure will be measured.
- 4-Week Washout Period: During the washout period, women can return to their usual
lifestyle. Meals will not be provided during this time.
- Visit 4: Visit 4 will include a telephone call only to discuss the next study phase and
schedule meal provision.
- Visit 5: Women will provide fasting blood and stool samples. Weight, waist circumference
and blood pressure will be measured. An exit interview may occur in person or via
phone/video conference to ask questions about how well the intervention was tolerated
and allow participants to provide feedback.
- Follow-Up: Approximately 6-months after consent and roughly 10 weeks after the end of
the dietary intervention, participants will be asked to complete a follow-up
questionnaire.
Study Type
Interventional
Primary Outcome
Proportion of Women Referred that are Consented
Secondary Outcome
Change in blood pressure assessed via electronic blood pressure monitor
Condition
Endometrial Cancer
Intervention
Time Restricted Eating (TRE) Schedule
Study Arms / Comparison Groups
Time Restricted Eating (TRE) Schedule
Description: For 6-weeks out of the 16-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 calorie-containing beverages within an 8 to 10-hour period that fits their schedule. The meal plans will be individualized to meet weight maintenance energy requirements.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
15
Start Date
March 1, 2021
Completion Date
February 1, 2022
Primary Completion Date
December 31, 2021
Eligibility Criteria
Inclusion Criteria:
- Females aged 18 years or older
- Diagnosed with endometrial cancer (any stage)
- Clinically overweight or obese (BMI >= 25 kg/m2)
- At least 3 months post-cancer surgery and/or treatment
- Weight stable for 3 months prior to beginning the study (<4kg weight loss/gain)
- Have a cell phone that is able to download a phone App and able to use phone during
the day
Exclusion Criteria:
- Persons with special dietary requirements
- Unable to provide informed consent
- Unable to read, write, or fill in questionnaires in English
- Insulin dependent diabetes
- Night shift workers
- Persons not able to use cell phone during day (like for work)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mary Playdon, PhD, MPH, (801) 213-6264, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04783467
Organization ID
IRB_00126714
Responsible Party
Principal Investigator
Study Sponsor
University of Utah
Study Sponsor
Mary Playdon, PhD, MPH, Principal Investigator, University of Utah
Verification Date
March 2021