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Time-restricted Eating for Metabolic Disorders (READY Trial)
N/A
Waitlist Available
Led By Amy A Kirkham, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3, and 4 months post intervention period
Awards & highlights
Summary
This trial will study whether a new cancer prevention program can help reduce breast cancer risk factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 2, 3, and 4 months post intervention period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3, and 4 months post intervention period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to TRE for the 16-week intervention
Hemoglobin A1c
Secondary outcome measures
10-year cardiovascular disease risk
Alanine Transaminase
Blood Pressure
+17 moreOther outcome measures
Anxiety
Depression
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Standardized TRE protocol + Peer SupportExperimental Treatment2 Interventions
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.
Group II: Standardized TRE protocol + External SupportExperimental Treatment2 Interventions
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.
Group III: Personalized TRE protocol + Peer SupportExperimental Treatment2 Interventions
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.
Group IV: Personalized TRE protocol + External SupportExperimental Treatment2 Interventions
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.
Group V: Control GroupActive Control1 Intervention
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).
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Who is running the clinical trial?
University of TorontoLead Sponsor
698 Previous Clinical Trials
1,020,424 Total Patients Enrolled
Amy A Kirkham, PhDPrincipal InvestigatorUniversity of Toronto
2 Previous Clinical Trials
103 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a job that requires you to work at night or rotate shifts.You have never had cancer before.Women. (Note: This criterion needs more context to provide a clear summary.)You have experienced an eating disorder and have reported it yourself.You have Type 1 diabetes.You have made significant changes to your diet in the past three months, such as counting calories or following a ketogenic diet.You are currently taking insulin, sulfonylureas, or GLP-1 receptor agonists for diabetes.You have a smartphone that can connect to other devices using Bluetooth and runs on either Apple or Android operating system.You have been eating less than three meals a day or within a 12-hour period consistently for the past three months.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized TRE protocol + Peer Support
- Group 2: Personalized TRE protocol + External Support
- Group 3: Control Group
- Group 4: Standardized TRE protocol + External Support
- Group 5: Standardized TRE protocol + Peer Support
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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