Metabolic Disturbance
Conditions
Brief summary
This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.
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.
Interventions
BEHAVIORALStandardized TRE Protocol
A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.
BEHAVIORALPersonalized 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.
BEHAVIORALExternal 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.
BEHAVIORALPeer Support for TRE
Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to TRE for the 16-week intervention | 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. |
| Hemoglobin A1c | 16 Weeks | Collected via venipuncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Free-living glucose control | 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 |
| C-Reactive Protein | 16 Weeks | Measured via venipuncture and core lab lab analysis |
| Lipid profile | 16 Weeks | Measured via venipuncture and core lab lab analysis |
| Body weight | 16 Weeks | Measured via Fitbit Aria Air scale at baseline and 16-weeks but also once per week to evaluate trajectory of change |
| Waist circumference | 16 weeks | Measured via provided circumference measuring tape as the average of 2 measurements |
| Blood Pressure | 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. |
| 10-year cardiovascular disease risk | 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). |
| Metabolic syndrome (NCEP/ATP III criteria) | 16 Weeks | As defined by the NCEP/ATP III criteria using measurements taken using provided study tools |
| Metabolic syndrome z-score | 16 Weeks | As defined by the NCEP/ATP III criteria and age and ethnic specific calculations |
| TRE acceptability and appropriateness | 16 Weeks | Evaluated via an 'End of Study Survey' (including a Diet Satisfaction Score Tool and acceptability questions) and semi-structured qualitative interviews |
| TRE Adoption | 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). |
| Cost of intervention delivery | 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. |
| TRE Sustainability | 1, 2, 3, and 4 months post intervention period | Evaluated via participant self-report of continued TRE post-intervention |
| TRE Adverse Events | 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) |
| Health-related quality of life | 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) |
| Sleep duration | 16 Weeks | Measured via FitBit Inspire 2 as 7-day average |
| Sedentary time | 16 Weeks | Measured via FitBit Inspire 2 as 7-day average |
| Physical activity | 16 Weeks | Measured via FitBit Inspire 2 as 7-day average |
| Alanine Aminotransferase | 16 Weeks | Measured via venipuncture and core lab lab analysis |
| HOMA-IR | 16 Weeks | Homeostatic Model Assessment for Insulin Resistance calculated as fasting glucose in mmol/l\*fasting insulin in μU/ml/22.5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 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. |
| Depression | 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. |
Countries
Canada
Outcome results
None listed