Time-restricted Eating in Survivors Trial (TEST)

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.

Study Overview

• Status: Completed
• Conditions: Cancer, Breast
• Intervention / Treatment: Behavioral: Time-restricted eating

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Edmonton Clinic Health Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Weekday time-restricted eating; The 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.

Behavioral: Time-restricted eating; Restriction of calorie intake to an 8-hour window, with water only fasting in the remaining 16 hours of the 24-hour period; Other Names: intermittent fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Framingham 10-year cardiovascular risk score (%)	Calculated using the Canadian Cardiovascular scoring system	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visceral adipose tissue	measured via magnetic resonance fat-water separation imaging	8 weeks
Thigh adipose tissue fraction	Relative measure of amount of inter+intra muscular adipose tissue within the thigh muscle measured via magnetic resonance fat-water separation imaging	8 weeks
Liver adipose tissue fraction	Relative measure of amount of adipose tissue within the liver	8 weeks
Cardiorespiratory fitness	Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test	8 weeks
Resting energy expenditure	Collected via metabolic cart in supine resting position after overnight fast	8 weeks
Respiratory quotient	Collected via metabolic cart in supine resting position after overnight fast	8 weeks
Lipid profile	Collected via analysis of fasting blood sample by Lifelabs commercial laboratory	8 weeks
Hemoglobin A1c	Collected via analysis of blood sample by Lifelabs commercial laboratory	8 weeks
Waist circumference	measured as the average of two measurements to the nearest 0.5 cm.	8 weeks
Fasting glucose	Collected via analysis of fasting blood sample by Lifelabs commercial laboratory	8 weeks
Fasting insulin	Collected via analysis of fasting blood sample by Lifelabs commercial laboratory	8 weeks
Resting systolic and diastolic blood pressure	measured as the average of two measurements 60 seconds apart following 5-10 minutes of supine rest using an automated device	8 weeks
Body mass	measured by physicians scale after overnight fast	8 weeks
Whole-body fat mass	estimated using8-point bioelectric impedance (Seca)	8 weeks
Whole-body fat-free mass	estimated using8-point bioelectric impedance (Seca)	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake	Measured via diet records on 3 consecutive weekdays that were analyzed via Food Processor Nutrition Analysis Software	8 weeks
Activity	24-hour Measured via Sensewear Pro accelerometer worn on the arm for 3 consecutive weekdays	Change between measurement at baseline and 8 weeks
Adherence to intervention	Collected via participant responses to automated text messages asking participants to self-report the time they started and stopped eating each day. Calculated as the % of prescribed days to follow the intervention where participant reported performing a 16 hour or longer fast.	Ongoing for duration of intervention
Participant acceptability	assessed by a researcher-developed end of study questionnaire as: 1) a subjective difficulty rating for following TRE on a scale of 1-10 and 2) rating the dietitian and support calls as 'very helpful' or 'somewhat helpful' on a 5-point Likert scale (other options were 'neutral,' 'somewhat helpful,' and 'unhelpful')	8 weeks
Intervention fidelity	determined as completion rates of the intervention components (registered dietitian consult call, the three support calls, and response rate to the text messages)	8 weeks
Intervention sustainability	Rate of continuing to follow TRE one-month post-intervention completion (without further support or instructions) collected by phone follow-up	1 month post intervention
Intervention sustainability confidence	Average subjective rating of confidence, on 0-100% scale, in ability to follow TRE for one year or longer	8 weeks
Intervention delivery cost	Estimated as average time spent by personnel on intervention delivery multiplied by the hourly rate for that personnel	Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
Symptoms	Collected at each of the support phone calls at weeks 1, 3, 6 of the intervention. The research coordinator asked participants if they experienced any symptoms on a pre-determined list or any additional symptoms. Symptoms were only recorded if the participant reported that they were related to the intervention or were unsure if they were related. Symptoms attributed to other life events (i.e., heat wave, stress at work) were not recorded.	Through study completion, lasting 12-24 weeks depending on chemotherapy protocol

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Actual): July 28, 2021
• Study Completion (Actual): July 28, 2021

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HREBA.CC-20-0077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No