Remote Time-restricted EAting DeliverY
READY
Proof-of-Concept of Time-Restricted Eating as a Novel Lifestyle Intervention for Breast Cancer Prevention
1 other identifier
interventional
178
1 country
1
Brief Summary
This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedStudy Start
First participant enrolled
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2024
CompletedOctober 1, 2025
September 1, 2025
1.2 years
July 7, 2022
September 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Adherence to TRE for the 16-week intervention
Assessed daily through twice daily automated text messages asking participants to respond with what time they started and stopped eating that day.
16-week average
Hemoglobin A1c
Collected via venipuncture
16 Weeks
Secondary Outcomes (20)
HOMA-IR
16 Weeks
Free-living glucose control
16 Weeks
C-Reactive Protein
16 Weeks
Lipid profile
16 Weeks
Body weight
16 Weeks
- +15 more secondary outcomes
Other Outcomes (2)
Anxiety
16 weeks
Depression
16 weeks
Study Arms (5)
Standardized TRE protocol + External Support
EXPERIMENTALParticipants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12.
Standardized TRE protocol + Peer Support
EXPERIMENTALParticipants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged.
Personalized TRE protocol + External Support
EXPERIMENTALParticipants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the 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. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12.
Personalized TRE protocol + Peer Support
EXPERIMENTALParticipants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the 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. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged.
Control Group
NO INTERVENTIONParticipants will be asked to maintain their usual diet and physical activity patterns for 16 weeks. They will receive the same number and timing of calls from study staff as the other groups (at randomization, 1, 3, 6, 12 weeks).
Interventions
A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.
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.
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.
Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.
Eligibility Criteria
You may qualify if:
- Females
- No cancer history
- ≥50 years old
- Have metabolic dysfunction (defined as self-reported diagnosis of pre-diabetes, type 2 diabetes, or at least moderate Canadian diabetes risk (CANRISK) score)
- Access to an Ontario Lifelabs location
- Owns a smartphone with Bluetooth capability with Apple or Android operating system
You may not qualify if:
- Type 1 diabetes
- Taking exogenous insulin, sulfonylureas, or GLP-1 receptor agonists
- Self-reported history of an eating disorder
- BMI \<18.5 kg/m
- Working night or rotating shifts
- Eating window \<12 hours or consistently eating less than 3 meals/day in the past 3 months
- Major dietary changes within the past 3 months (i.e. calorie counting, ketogenic diet)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Remote Ontario-wide
Toronto, Ontario, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy A Kirkham, PhD
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Amy Kirkham, Assistant Professor
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 12, 2022
Study Start
July 7, 2022
Primary Completion
September 20, 2023
Study Completion
January 30, 2024
Last Updated
October 1, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share