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Completed

NCT Number: NCT05454943

Remote Time-restricted EAting DeliverY

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

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Remote Ontario-wide

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standardized TRE Protocol

Behavioral

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

Personalized TRE Protocol

Behavioral

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 for TRE

Behavioral

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.

Peer Support for TRE

Behavioral

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

Primary outcomes

  1. Adherence to TRE for the 16-week intervention

    Time frame: 16-week average

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

  2. Hemoglobin A1c

    Time frame: 16 Weeks

    Collected via venipuncture

Secondary outcomes

  1. HOMA-IR

    Time frame: 16 Weeks

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

  2. Free-living glucose control

    Time frame: 16 Weeks

    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

  3. C-Reactive Protein

    Time frame: 16 Weeks

    Measured via venipuncture and core lab lab analysis

  4. Lipid profile

    Time frame: 16 Weeks

    Measured via venipuncture and core lab lab analysis

  5. Body weight

    Time frame: 16 Weeks

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

  6. Waist circumference

    Time frame: 16 weeks

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

  7. Blood Pressure

    Time frame: 16 Weeks

    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.

  8. 10-year cardiovascular disease risk

    Time frame: 16 Weeks

    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).

  9. Metabolic syndrome (NCEP/ATP III criteria)

    Time frame: 16 Weeks

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

  10. Metabolic syndrome z-score

    Time frame: 16 Weeks

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

  11. Alanine Aminotransferase

    Time frame: 16 Weeks

    Measured via venipuncture and core lab lab analysis

  12. TRE acceptability and appropriateness

    Time frame: 16 Weeks

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

  13. TRE Adoption

    Time frame: 16 Weeks

    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).

  14. Cost of intervention delivery

    Time frame: 16 Weeks

    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.

  15. TRE Sustainability

    Time frame: 1, 2, 3, and 4 months post intervention period

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

  16. TRE Adverse Events

    Time frame: 16 Weeks

    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)

  17. Health-related quality of life

    Time frame: 16 Weeks

    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)

  18. Sleep duration

    Time frame: 16 Weeks

    Measured via FitBit Inspire 2 as 7-day average

  19. Sedentary time

    Time frame: 16 Weeks

    Measured via FitBit Inspire 2 as 7-day average

  20. Physical activity

    Time frame: 16 Weeks

    Measured via FitBit Inspire 2 as 7-day average

Other outcomes

  1. Anxiety

    Time frame: 16 weeks

    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.

  2. Depression

    Time frame: 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

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

Acronym: READY

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 12, 2022
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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