Remote Time-restricted EAting DeliverY (READY)

University of Toronto

Status: Completed

Conditions: Metabolic Disturbance

Treatments: Behavioral: Personalized TRE Protocol; Behavioral: External Support for TRE; Behavioral: Peer Support for TRE; Behavioral: Standardized TRE Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05454943

RIS42756

Details and patient eligibility

About

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

Full 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.

Enrollment: 178 patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 5 patient groups

Standardized TRE protocol + External Support

Experimental group

Description:

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.

Treatment:

Behavioral: Standardized TRE Protocol

Behavioral: External Support for TRE

Standardized TRE protocol + Peer Support

Experimental group

Description:

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.

Treatment:

Behavioral: Standardized TRE Protocol

Behavioral: Peer Support for TRE

Personalized TRE protocol + External Support

Experimental group

Description:

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.

Treatment:

Behavioral: External Support for TRE

Behavioral: Personalized TRE Protocol

Personalized TRE protocol + Peer Support

Experimental group

Description:

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.

Treatment:

Behavioral: Peer Support for TRE

Behavioral: Personalized TRE Protocol

Control Group

No Intervention group

Description:

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).