Remote Time-restricted EAting DeliverY (READY)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Metabolic Disturbance
• Intervention / Treatment: Behavioral: Standardized TRE Protocol; Behavioral: External Support for TRE; Behavioral: Peer Support for TRE; Behavioral: Personalized TRE Protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy A Kirkham, PhD; Phone Number: 416-946-4069; Email: amy.kirkham@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Remote Ontario-wide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized TRE protocol + External Support; 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.	Behavioral: Standardized TRE Protocol; A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.; 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.
Experimental: Standardized TRE protocol + Peer Support; 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.	Behavioral: Standardized TRE Protocol; A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.; Behavioral: Peer Support for TRE; Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.
Experimental: Personalized TRE protocol + External Support; 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.	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: 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.
Experimental: Personalized TRE protocol + Peer Support; 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.	Behavioral: Peer Support for TRE; Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.; 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.
No Intervention: Control Group; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA-IR	Homeostatic Model Assessment for Insulin Resistance calculated as fasting glucose in mmol/l*fasting insulin in μU/ml/22.5	16 Weeks
Free-living glucose control	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	16 Weeks
C-Reactive Protein	Measured via venipuncture and core lab lab analysis	16 Weeks
Lipid profile	Measured via venipuncture and core lab lab analysis	16 Weeks
Body weight	Measured via Fitbit Aria Air scale at baseline and 16-weeks but also once per week to evaluate trajectory of change	16 Weeks
Waist circumference	Measured via provided circumference measuring tape as the average of 2 measurements	16 weeks
Blood Pressure	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.	16 Weeks
10-year cardiovascular disease risk	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).	16 Weeks
Metabolic syndrome (NCEP/ATP III criteria)	As defined by the NCEP/ATP III criteria using measurements taken using provided study tools	16 Weeks
Metabolic syndrome z-score	As defined by the NCEP/ATP III criteria and age and ethnic specific calculations	16 Weeks
Alanine Aminotransferase	Measured via venipuncture and core lab lab analysis	16 Weeks
TRE acceptability and appropriateness	Evaluated via an 'End of Study Survey' (including a Diet Satisfaction Score Tool and acceptability questions) and semi-structured qualitative interviews	16 Weeks
TRE Adoption	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).	16 Weeks
Cost of intervention delivery	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.	16 Weeks
TRE Sustainability	Evaluated via participant self-report of continued TRE post-intervention	1, 2, 3, and 4 months post intervention period
TRE Adverse Events	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)	16 Weeks
Health-related quality of life	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)	16 Weeks
Sleep duration	Measured via FitBit Inspire 2 as 7-day average	16 Weeks
Sedentary time	Measured via FitBit Inspire 2 as 7-day average	16 Weeks
Physical activity	Measured via FitBit Inspire 2 as 7-day average	16 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	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.	16 weeks
Depression	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.	16 weeks

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Amy A Kirkham, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Anticipated): December 6, 2023
• Study Completion (Anticipated): December 6, 2023

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RIS42756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No