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Completed

NCT Number: NCT05639829

Time-restricted Eating in Survivors Trial

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.

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Key information

Conditions

Cancer, Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Edmonton Clinic Health Academy

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time-restricted eating

Behavioral

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

Primary outcomes

  1. Framingham 10-year cardiovascular risk score (%)

    Time frame: 8 weeks

    Calculated using the Canadian Cardiovascular scoring system

Secondary outcomes

  1. Visceral adipose tissue

    Time frame: 8 weeks

    measured via magnetic resonance fat-water separation imaging

  2. Thigh adipose tissue fraction

    Time frame: 8 weeks

    Relative measure of amount of inter+intra muscular adipose tissue within the thigh muscle measured via magnetic resonance fat-water separation imaging

  3. Liver adipose tissue fraction

    Time frame: 8 weeks

    Relative measure of amount of adipose tissue within the liver

  4. Cardiorespiratory fitness

    Time frame: 8 weeks

    Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test

  5. Resting energy expenditure

    Time frame: 8 weeks

    Collected via metabolic cart in supine resting position after overnight fast

  6. Respiratory quotient

    Time frame: 8 weeks

    Collected via metabolic cart in supine resting position after overnight fast

  7. Lipid profile

    Time frame: 8 weeks

    Collected via analysis of fasting blood sample by Lifelabs commercial laboratory

  8. Hemoglobin A1c

    Time frame: 8 weeks

    Collected via analysis of blood sample by Lifelabs commercial laboratory

  9. Waist circumference

    Time frame: 8 weeks

    measured as the average of two measurements to the nearest 0.5 cm.

  10. Fasting glucose

    Time frame: 8 weeks

    Collected via analysis of fasting blood sample by Lifelabs commercial laboratory

  11. Fasting insulin

    Time frame: 8 weeks

    Collected via analysis of fasting blood sample by Lifelabs commercial laboratory

  12. Resting systolic and diastolic blood pressure

    Time frame: 8 weeks

    measured as the average of two measurements 60 seconds apart following 5-10 minutes of supine rest using an automated device

  13. Body mass

    Time frame: 8 weeks

    measured by physicians scale after overnight fast

  14. Whole-body fat mass

    Time frame: 8 weeks

    estimated using8-point bioelectric impedance (Seca)

  15. Whole-body fat-free mass

    Time frame: 8 weeks

    estimated using8-point bioelectric impedance (Seca)

Other outcomes

  1. Dietary intake

    Time frame: 8 weeks

    Measured via diet records on 3 consecutive weekdays that were analyzed via Food Processor Nutrition Analysis Software

  2. Activity

    Time frame: Change between measurement at baseline and 8 weeks

    24-hour Measured via Sensewear Pro accelerometer worn on the arm for 3 consecutive weekdays

  3. Adherence to intervention

    Time frame: Ongoing for duration of 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.

  4. Participant acceptability

    Time frame: 8 weeks

    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')

  5. Intervention fidelity

    Time frame: 8 weeks

    determined as completion rates of the intervention components (registered dietitian consult call, the three support calls, and response rate to the text messages)

  6. Intervention sustainability

    Time frame: 1 month post intervention

    Rate of continuing to follow TRE one-month post-intervention completion (without further support or instructions) collected by phone follow-up

  7. Intervention sustainability confidence

    Time frame: 8 weeks

    Average subjective rating of confidence, on 0-100% scale, in ability to follow TRE for one year or longer

  8. Intervention delivery cost

    Time frame: Through study completion, lasting 12-24 weeks depending on chemotherapy protocol

    Estimated as average time spent by personnel on intervention delivery multiplied by the hourly rate for that personnel

  9. Symptoms

    Time frame: Through study completion, lasting 12-24 weeks depending on chemotherapy protocol

    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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Acronym: TEST

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 6, 2022
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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