Clinical trial NCT07009288: A Study of Time-Restricted Eating in Childhood Cancer Survivors
Official title: Decreasing Cardiometabolic Risk in Childhood Cancer Survivors: The STRENGTH (Survivors Engaged in Time-Restricted EatiNG After THerapy) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Childhood Cancer Survivors
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase 2b randomized controlled trial of a TRE intervention among childhood cancer survivor participants with overweight and obesity in the Childhood Cancer Survivor Study (CCSS), designed according to the ORBIT model for behavioral intervention development.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change in weight
timeFrame: at 12 months
Secondary outcomes:
measure: Change in glucose
timeFrame: up to 12 months
measure: Change in insulin
timeFrame: up to 12 months
measure: Change in HbA1c
timeFrame: up to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital (Data Collection Only)
state: Tennessee
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center (Data Collection Only)
state: Washington
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Danielle Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: