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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Restricted Eating (TRE) Schedule | Experimental | 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. |
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| Control Schedule | No Intervention | For 4 weeks out of the 16-week randomized dietary crossover study, women will receive frozen lunch and dinner meals, and a standardized breakfast and snacks menu. The meal plans will be individualized to meet weight maintenance energy requirements. There are no restrictions on timing of eating. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Eating (TRE) Schedule | Behavioral | [See arm/group descriptions] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Women Referred that are Consented | Feasibility of the TRE intervention will be measured be calculating the proportion (%) of women who were referred that were consented into the study. The study will be considered feasible of > 70% of participants are consented and retained. | From baseline to Visit 5 (Week 16) |
| Attrition as a Function of Time | Number of participants who withdraw throughout the course of the study. | From baseline to Visit 5 (Week 16) |
| 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 16) |
| 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 14-16 hours per day during the TRE phase according to the MCC App 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 16) |
| 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 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure assessed via electronic blood pressure monitor | Blood pressure will be taken using an electronic blood pressure monitor. | Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16) |
| Change in waist circumference assessed via measuring tape |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Playdon, PhD, MPH | Contact | (801) 213-6264 | mary.playdon@hci.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary Playdon, PhD, MPH | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36971688 | Derived | Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D014198 | Trehalase |
| D001071 | Appointments and Schedules |
| ID | Term |
|---|---|
| D004186 | Disaccharidases |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
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Waist circumference will be measured using a measuring tape. |
| Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16) |
| Change in BMI assessed via height and weight | Participants' height and weight will be measured with stadiometer and electronic scales and used to calculate BMI. | Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16) |
| Change in fasting blood glucose assessed via blood draw | A small sample of blood will be taken from participants at designated study visits. | Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16) |
| Change in HOMA-IR assessed via blood draw | A small sample of blood will be taken from participants at designated study visits. | Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16) |
| Change in c-peptide assessed via blood draw | A small sample of blood will be taken from participants at designated study visits | Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16) |
| Change in triglycerides assessed via blood draw | A small sample of blood will be taken from participants at designated study visits | Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16) |
| Change in HDL-cholesterol assessed via blood draw | A small sample of blood will be taken from participants at designated study visits | Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16) |
| 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 | Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16) |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D045762 |
| Enzymes and Coenzymes |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |