This clinical trial studies the feasibility and acceptability of a dietary intervention called time restricted eating for the improvement of metabolic health in native Hawaiian/Pacific Islander women who are at risk for endometrial cancer. Within the Native Hawaiian/Pacific Islander community, there are high levels of endometrial cancer risk factors like obesity and diabetes. Another risk factor is a type of pre-cancer characterized by overgrowth of the layer of cells that lines the uterus (endometrial hyperplasia). Time restricted eating is a type of meal schedule where food (meals, snacks and beverages with calories) is eaten within a specific window of time (e.g. 8 to 10 hours) during a 24-hour period. Previous research suggests that structuring mealtimes in a certain way can prevent diseases like diabetes, cardiovascular disease and cancer. Other research suggests time restricted eating is safe and can improve body weight, fat mass, energy, metabolism, inflammation and blood pressure among other body functions. Time restricted eating may improve these risk factors and prevent endometrial cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04763902.
PRIMARY OBJECTIVES:
I. Conduct focus groups to determine sociocultural influences on:
Ia. Dietary behavior including meal timing
Ib. Dietary preferences
Ic. Proposed meal plans and intervention design
Id. Perceptions of weight loss and body image
II. Determine the feasibility, fidelity and preliminary acceptability of time restricted eating (TRE) among Pacific Islander women at risk for developing endometrial cancer.
III. Measure the variability and magnitude of change in effect size of metabolic health parameters in response to TRE among Pacific Islander women at risk for developing endometrial cancer.
OUTLINE:
AIM I: Patients attend a focus group over 60-90 minutes via videoconferencing where they discuss sociocultural influences on dietary behavior and perceptions of weight loss and body image. Patients also complete a demographic questionnaire.
AIM II: Patients are randomized to 1 of 2 arms.
ARM I (CONTROL DIET): Patients receive frozen lunch and dinner meals and a standardized, individualized breakfast and snacks meal plan for 4 weeks. After 4 weeks, patients return to their usual lifestyle and diet for 4 weeks, and then receive the TRE intervention.
ARM II (TRE DIET): Patients receive prepared frozen lunch and dinner meals for 4 weeks as in Arm I, but consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule. After 4 weeks, patients return to their usual lifestyle and diet for 4 weeks, and then receive the control diet intervention.
After completion of study intervention, patients are followed up at 10 weeks.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorMary Playdon
