Standardized TRE Protocol for Metabolic Disturbances

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Remote Ontario-wide, Toronto, Canada
Metabolic Disturbances
Standardized TRE Protocol - Behavioral
Eligibility
18+
Female
What conditions do you have?
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 21 Secondary · Reporting Duration: 1, 2, 3, and 4 months post intervention period

Month 4
TRE Sustainability
16 Weeks
10-year cardiovascular disease risk
Alanine Aminotransferase
Blood Pressure
Body weight
C-Reactive Protein
Cost of intervention delivery
Free-living glucose control
HOMA-IR
Health-related quality of life
Hemoglobin A1c
Lipid profile
Metabolic syndrome
Metabolic syndrome (NCEP/ATP III criteria)
Metabolic syndrome z-score
Physical activity
Sedentary time
Sleep duration
TRE Adoption
TRE Adverse Events
TRE acceptability and appropriateness
16 weeks
Anxiety
Depression
Waist circumference
16-week average
Adherence to TRE for the 16-week intervention

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Control Group
1 of 5
Standardized TRE protocol + Peer Support
1 of 5
Standardized TRE protocol + External Support
1 of 5
Personalized TRE protocol + Peer Support
1 of 5
Personalized TRE protocol + External Support
1 of 5
Active Control
Experimental Treatment

178 Total Participants · 5 Treatment Groups

Primary Treatment: Standardized TRE Protocol · No Placebo Group · N/A

Standardized TRE protocol + Peer SupportExperimental Group · 2 Interventions: Standardized TRE Protocol, Peer Support for TRE · Intervention Types: Behavioral, Behavioral
Standardized TRE protocol + External SupportExperimental Group · 2 Interventions: Standardized TRE Protocol, External Support for TRE · Intervention Types: Behavioral, Behavioral
Personalized TRE protocol + Peer SupportExperimental Group · 2 Interventions: Personalized TRE Protocol, Peer Support for TRE · Intervention Types: Behavioral, Behavioral
Personalized TRE protocol + External SupportExperimental Group · 2 Interventions: Personalized TRE Protocol, External Support for TRE · Intervention Types: Behavioral, Behavioral
Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1, 2, 3, and 4 months post intervention period
Closest Location: Remote Ontario-wide · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Metabolic Disturbances
0 CompletedClinical Trials

Who is running the clinical trial?

University of TorontoLead Sponsor
622 Previous Clinical Trials
719,202 Total Patients Enrolled
1 Trials studying Metabolic Disturbances
50 Patients Enrolled for Metabolic Disturbances
Amy A Kirkham, PhDPrincipal InvestigatorUniversity of Toronto
1 Previous Clinical Trials
56 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female.
You are 50 years of age or older.\n
You own a smartphone with Bluetooth capability with Apple or Android operating system.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.