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Time Restricted Eating (TRE) Schedule for Endometrial Cancer (TIMESPAN Trial)

N/A
Waitlist Available
Led By Mary Playdon, PhD, MPH
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (visit 1), visit 2 (week 2), visit 3 (week 6), visit 5 (week 14)
Awards & highlights

TIMESPAN Trial Summary

This trialwill study how a diet of time-restricted eating affects metabolic health and cancer prevention in Native Hawaiian/Pacific Islander women.

TIMESPAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (visit 1), visit 2 (week 2), visit 3 (week 6), visit 5 (week 14)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 1), visit 2 (week 2), visit 3 (week 6), visit 5 (week 14) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Attrition as a Function of Time
Fidelity of Time Restricted Eating (TRE) Intervention
Number of TRE-Adherent Days per Week
+3 more
Secondary outcome measures
Change in BMI assessed via height and weight
Change in HDL-cholesterol assessed via blood draw
Change in HOMA-IR assessed via blood draw
+6 more

TIMESPAN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Time Restricted Eating (TRE) ScheduleExperimental Treatment1 Intervention
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).
Group II: Control ScheduleActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time Restricted Eating (TRE) Schedule
2021
N/A
~20

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,104 Previous Clinical Trials
1,782,516 Total Patients Enrolled
3 Trials studying Endometrial Cancer
83 Patients Enrolled for Endometrial Cancer
National Center for Advancing Translational Sciences (NCATS)NIH
324 Previous Clinical Trials
401,609 Total Patients Enrolled
1 Trials studying Endometrial Cancer
150 Patients Enrolled for Endometrial Cancer
Mary Playdon, PhD, MPHPrincipal Investigator - University of Utah
University of Utah
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Endometrial Cancer
15 Patients Enrolled for Endometrial Cancer
~4 spots leftby Jun 2025
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