RecruitingNot ApplicableNCT07009288

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

300 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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

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Interventions

OTHERChildren's Oncology Group Heart Health Link

Educational materials on healthy lifestyle behaviors.

OTHERMonthly weights

Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat

OTHERFasting

(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)

OTHERCalls

Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text

OTHERParticipant 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

OTHERDried blood spot

Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.


Locations(4)

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

View Full Details on ClinicalTrials.gov

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NCT07009288


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