Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
178 participants
INTERVENTIONAL
2022-07-07
2024-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Standardized TRE Protocol
A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.
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.
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.
Standardized TRE Protocol
A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.
Peer Support for TRE
Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.
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.
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.
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.
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.
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.
Peer Support for TRE
Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.
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).
No interventions assigned to this group
Interventions
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Standardized TRE Protocol
A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.
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.
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.
Peer Support for TRE
Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
50 Years
FEMALE
Yes
Sponsors
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University of Toronto
OTHER
Responsible Party
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Amy Kirkham
Amy Kirkham, Assistant Professor
Principal Investigators
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Amy A Kirkham, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Remote Ontario-wide
Toronto, Ontario, Canada
Countries
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Other Identifiers
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RIS42756
Identifier Type: -
Identifier Source: org_study_id
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