A Study of Time-Restricted Eating in Childhood Cancer Survivors
NCT ID: NCT07009288
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-05-27
2031-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Intervention Group
Participants will be instructed to participate in time-restricted eating, building to a 16-hour fast per day (not eating or drinking calorie-enriched beverages such as soda or nutritional shakes for a 16-hour window, such as 6pm -10am or 7pm-11am). These participants will also receive motivational phone/video calls with a trained health coach, daily text message reminders of when to start and stop their fasting, and monthly weight check-ins.
Monthly weights
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
Fasting
(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)
Calls
Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text
Participant Questionnaires
Questions on worry, perceived self-efficacy, health beliefs and knowledge of late effects (adapted from EQUAL study), Behavioral Risk Factor Surveillance System, Physical Activity Questionnaire, Link to Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool with accompanying sleep module
Dried blood spot
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.
Control Group
Participants will receive the standard of care electronic handouts through the Way to Health platform, and monthly weight check-ins.
Children's Oncology Group Heart Health Link
Educational materials on healthy lifestyle behaviors.
Monthly weights
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
Dried blood spot
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.
Interventions
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Children's Oncology Group Heart Health Link
Educational materials on healthy lifestyle behaviors.
Monthly weights
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
Fasting
(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)
Calls
Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text
Participant Questionnaires
Questions on worry, perceived self-efficacy, health beliefs and knowledge of late effects (adapted from EQUAL study), Behavioral Risk Factor Surveillance System, Physical Activity Questionnaire, Link to Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool with accompanying sleep module
Dried blood spot
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.
Eligibility Criteria
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Inclusion Criteria
* Are ≥18 years old
* Self-reported body mass index ≥ 25 kg/m2
* Are not pregnant or do not intend to become pregnant in the next year
* Stable weight over the past 3 months (+/- 10 pounds)
* If on oral medication for insulin resistance (ie, metformin), elevated blood pressure, or dyslipidemia, medication dose must be stable (ie, unchanged \> 3 months)
* Have internet access (can be via smartphone or computer). If neither device is available, the study can loan participants a Wi-Fi enabled device.
Exclusion Criteria
* Do not speak English
* Already fasting \>13 hours per 24-hour day
* On insulin or GLP-1 agonist
* Diagnosis of type 1 diabetes mellitus
* Enrolled in a formal weight management program or other weight loss trial
* History of an eating disorder
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Danielle Friedman, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Hunter College
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
St. Jude Children's Research Hospital (Data Collection Only)
Memphis, Tennessee, United States
Fred Hutchinson Cancer Research Center (Data Collection Only)
Seattle, Washington, United States
Countries
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Central Contacts
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Chaya Moskowitz, PhD
Role: CONTACT
Facility Contacts
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Danielle Friedman, MD
Role: primary
Chaya Moskowitz, PhD
Role: backup
Gregory Armstrong, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-250
Identifier Type: -
Identifier Source: org_study_id
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