A Study of Time-Restricted Eating in Childhood Cancer Survivors
Decreasing Cardiometabolic Risk in Childhood Cancer Survivors: The STRENGTH (Survivors Engaged in Time-Restricted EatiNG After THerapy) Study
1 other identifier
interventional
300
1 country
4
Brief Summary
This study will look at whether motivational sessions (including regular calls with a trained health coach) in combination with time-restricted eating (TRE) is an effective way to achieve weight loss and lower cardiometabolic risk in adult survivors of childhood cancer. The researchers will look at how effective this intervention is compared to the usual approach, which is to review educational materials and measure weight once a month. This study will not provide treatment for any disease or cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
4 active sites
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
May 27, 2025
CompletedFirst Submitted
Initial submission to the registry
May 28, 2025
CompletedFirst Posted
Study publicly available on registry
June 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2031
April 2, 2026
April 1, 2026
4.9 years
May 28, 2025
April 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in weight
at 12 months
Secondary Outcomes (3)
Change in glucose
up to 12 months
Change in insulin
up to 12 months
Change in HbA1c
up to 12 months
Study Arms (2)
Intervention Group
EXPERIMENTALParticipants 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.
Control Group
ACTIVE COMPARATORParticipants will receive the standard of care electronic handouts through the Way to Health platform, and monthly weight check-ins.
Interventions
Educational materials on healthy lifestyle behaviors.
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)
Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text
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
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.
Eligibility Criteria
You may qualify if:
- Enrolled in the Childhood Cancer Survivor Study (a cohort of 5+ year survivors of childhood cancer diagnosed at age \< 21 between 1970-1999 at 31 participating institutions in North America)
- 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.
You may not qualify if:
- Do not reside in the United States
- Do not speak English
- Eating window \< 12 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hunter College
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
St. Jude Children's Research Hospital (Data Collection Only)
Memphis, Tennessee, 38105, United States
Fred Hutchinson Cancer Research Center (Data Collection Only)
Seattle, Washington, 98109, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Friedman, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Team members conducting data analysis will be blinded to each participant's assignment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2025
First Posted
June 6, 2025
Study Start
May 27, 2025
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2031
Last Updated
April 2, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.