A Study of Time-Restricted Eating in Childhood Cancer Survivors

Phase 2

Recruiting

• Conditions: Childhood Cancer Survivors

• Registration Number: NCT07009288
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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. We 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-27
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2031-05
• Study Completion: 2031-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)
• Previously treated with radiation to the chest, abdomen, or total body
• 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 6 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
• Already fasting >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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent change in weight	at 12 months

Secondary Outcome Measures

Name	Time	Method
Change in glucose	up to 12 months	via dried blood spots
Change in insulin	up to 12 months	via dried blood spots
Change in HbA1c	up to 12 months	via dried blood spots

Trial Locations

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