A Study of Time-Restricted Eating in Childhood Cancer Survivors

May 26, 2026 updated by: Memorial Sloan Kettering Cancer Center

Decreasing Cardiometabolic Risk in Childhood Cancer Survivors: The STRENGTH (Survivors Engaged in Time-Restricted EatiNG After THerapy) Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chaya Moskowitz, PhD
  • Phone Number: 646-227-3607

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Danielle Friedman, MD
        • Contact:
          • Chaya Moskowitz, PhD
          • Phone Number: 646-227-3607
        • Contact:
          • Danielle Friedman, MD
          • Phone Number: 1-833-MSK-KIDS
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Hunter College
        • Contact:
        • Principal Investigator:
          • Jennifer Ford, PhD
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital (Data Collection Only)
        • Contact:
          • Gregory Armstrong, MD
          • Phone Number: 901-595-5892
        • Principal Investigator:
          • Gregory Armstrong, MD
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Fred Hutchinson Cancer Research Center (Data Collection Only)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Monthly weights
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
Other: Fasting
(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)
Other: Calls
Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text
Other: 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
Other: Dried blood spot
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.
Active Comparator: Control Group
Participants will receive the standard of care electronic handouts through the Way to Health platform, and monthly weight check-ins.
Other: Monthly weights
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
Other: Dried blood spot
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.
Other: Children's Oncology Group Heart Health Link
Educational materials on healthy lifestyle behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in weight
Time Frame: at 12 months
at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glucose
Time Frame: up to 12 months
via dried blood spots
up to 12 months
Change in insulin
Time Frame: up to 12 months
via dried blood spots
up to 12 months
Change in HbA1c
Time Frame: up to 12 months
via dried blood spots
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Danielle Friedman, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

May 28, 2025

First Submitted That Met QC Criteria

May 29, 2025

First Posted (Actual)

June 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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