Time-restricted Eating in Survivors Trial
TEST
1 other identifier
interventional
22
1 country
1
Brief Summary
Breast cancer survivors aged 60+ and with overweight/obesity who had completed chemotherapy 1-6 years earlier completed 8 weeks of 12-8 pm weekday-only time-restricted eating. The intervention was delivered by a registered dietitian call, twice-daily automated text messages asking about eating start/stop times, and three support phone calls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2021
CompletedFirst Submitted
Initial submission to the registry
November 9, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedApril 12, 2023
November 1, 2022
12 months
November 9, 2022
April 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Framingham 10-year cardiovascular risk score (%)
Calculated using the Canadian Cardiovascular scoring system
8 weeks
Secondary Outcomes (15)
Visceral adipose tissue
8 weeks
Thigh adipose tissue fraction
8 weeks
Liver adipose tissue fraction
8 weeks
Cardiorespiratory fitness
8 weeks
Resting energy expenditure
8 weeks
- +10 more secondary outcomes
Other Outcomes (9)
Dietary intake
8 weeks
Activity
Change between measurement at baseline and 8 weeks
Adherence to intervention
Ongoing for duration of intervention
- +6 more other outcomes
Study Arms (1)
Weekday time-restricted eating
EXPERIMENTALThe intervention consisted of 8 weeks of ad libitum TRE with a 12-8 pm 8-hour eating window on weekdays. Participants received instructions to only consume water, black coffee, or black tea from 8 pm to 12 pm on weekdays and during the weekend, where there were no restrictions on eating timing. No other dietary or physical activity instructions were given.
Interventions
Restriction of calorie intake to an 8-hour window, with water only fasting in the remaining 16 hours of the 24-hour period
Eligibility Criteria
You may qualify if:
- history of early-stage (I-III) breast cancer
- completed anthracycline-based chemotherapy 1-6 years earlier
- aged ≥60 years
- had a body mass index (BMI) \>25 kg/m2
You may not qualify if:
- taking lipid, glucose, or weight-lowering medications
- contraindications to maximal exercise testing or research MRI
- unstable thyroid disorder
- self-reported history of an eating disorder
- self-reported diagnosis of type 1 or 2 diabetes
- weight loss of ≥15 lbs in previous 3 months
- working night shifts
- could not provide consent in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Edmonton Clinic Health Academy
Edmonton, Alberta, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2022
First Posted
December 6, 2022
Study Start
August 5, 2020
Primary Completion
July 28, 2021
Study Completion
July 28, 2021
Last Updated
April 12, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share