Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Participants 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.

Participants 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.

Participants 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.

Participants 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.

Participants 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).

A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.

Standardized 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.

Personalized TRE Protocol

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.

External Support for TRE

Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.

Peer Support for TRE

Amy A Kirkham, PhD

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

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.

Remote Time-restricted EAting DeliverY

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

Evaluated via the Hospital Anxiety and Depression Scale (HADS); This 14-item questionnaire has a minimum score of 0 and maximum of 21, where a higher score is worse.

Assessed daily through twice daily automated text messages asking participants to respond with what time they started and stopped eating that day.

Homeostatic Model Assessment for Insulin Resistance calculated as fasting glucose in mmol/l\*fasting insulin in μU/ml/22.5

Participants will be provided with a Dexcom G6 continuous glucose monitor transmitter and sensor. This data will be evaluated as the 5-day average of: 24-hour, daytime, and nocturnal glucose concentration, time in hyper, normo and hypoglycemia, and glycemic variability

Measured via venipuncture and core lab lab analysis

Measured via Fitbit Aria Air scale at baseline and 16-weeks but also once per week to evaluate trajectory of change

Measured via provided circumference measuring tape as the average of 2 measurements

Participant will be provided with a Bios 3al1-3e blood pressure measuring device. After 5 minutes of quiet seated rest, blood pressure will be measured 6 times, 60 seconds apart in a standardized seated position with the average of the 2nd through 6th measurement used.

Calculated via both the Framingham and Reynolds 10-year CVD risk scores using measured collected for study purposes (i.e., age, total cholesterol, HDL, systolic blood pressure, smoking status, C-reactive protein, family history of heart disease).

As defined by the NCEP/ATP III criteria using measurements taken using provided study tools

As defined by the NCEP/ATP III criteria and age and ethnic specific calculations

Evaluated via an 'End of Study Survey' (including a Diet Satisfaction Score Tool and acceptability questions) and semi-structured qualitative interviews

Evaluated as uptake of each delivery model, defined as adherence to the intervention touch points (i.e., external support: support calls with staff; peer support: number of peer interactions; both: response rate to adherence).

Intervention costs will be evaluated and averaged per participant from the time required for intervention phone calls, scheduling, and technical support for adherence app by the study staff according to hourly rates of pay.

Evaluated via participant self-report of continued TRE post-intervention

Measured via experience of selected relevant Common Terminology Criteria for Adverse Events (CTCAE v5) with additional questions about duration and change in the revised 18-item version of the Three-Factor Eating Questionnaire (aka Eating Inventory)

Measured by the RAND-36 Physical Component Summary. Physical component summary of the RAND-36 questionnaire (minimum = 0, maximum = 50, a higher score is a better outcome)

Measured via FitBit Inspire 2 as 7-day average

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Remote Time-restricted EAting DeliverY	NCT05454943	Metabolic Distu...	Standardized TR... Personalized TR... External Suppor... Peer Support fo...	50 Years -	University of Toronto
Remote Time-restricted EAting DeliverY	NCT05454943	Metabolic Distu...	Standardized TR... Personalized TR... External Suppor... Peer Support fo...	50 Years -	University of Toronto

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