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Remote Time-restricted EAting DeliverY

NCT05454943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2025-10-01

No results posted yet for this study

Summary

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

Conditions

  • Metabolic Disturbance

Interventions

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.

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Principal Investigators

  • Amy A Kirkham, PhD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2023-09-20
Completion
2024-01-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05454943 on ClinicalTrials.gov