NCT05454943

Remote Time-restricted EAting DeliverY

Proof-of-Concept of Time-Restricted Eating as a Novel Lifestyle Intervention for Breast Cancer Prevention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.

Detailed description

TRE is an eating pattern where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE is a simple and accessible lifestyle intervention with high adherence potential that may target both biological and behavioural mechanisms of breast cancer risk.

Conditions

• Metabolic Disturbance

Interventions

Type	Name	Description
BEHAVIORAL	Standardized TRE Protocol	A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.
BEHAVIORAL	Personalized TRE Protocol	A personalized TRE protocol following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week.
BEHAVIORAL	External Support for TRE	External support (from study staff) that includes consultation with a registered dietitian and ongoing tailored feedback via support calls at weeks 1, 3, 6, and 12.
BEHAVIORAL	Peer Support for TRE	Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.

Timeline

• Start date: 2022-07-07
• Primary completion: 2023-09-20
• Completion: 2024-01-30
• First posted: 2022-07-12
• Last updated: 2025-10-01

Locations

1 site across 1 country: Canada