A Study of Time-Restricted Eating in Childhood Cancer Survivors

NCT ID: NCT07009288

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-27

Study Completion Date

2031-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
Team members conducting data analysis will be blinded to each participant's assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Monthly weights

Intervention Type OTHER

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

Fasting

Intervention Type OTHER

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

Calls

Intervention Type OTHER

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

Participant Questionnaires

Intervention Type OTHER

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

Dried blood spot

Intervention Type OTHER

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

Control Group

Participants will receive the standard of care electronic handouts through the Way to Health platform, and monthly weight check-ins.

Group Type ACTIVE_COMPARATOR

Children's Oncology Group Heart Health Link

Intervention Type OTHER

Educational materials on healthy lifestyle behaviors.

Monthly weights

Intervention Type OTHER

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

Dried blood spot

Intervention Type OTHER

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

Interventions

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Children's Oncology Group Heart Health Link

Educational materials on healthy lifestyle behaviors.

Intervention Type OTHER

Monthly weights

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

Intervention Type OTHER

Fasting

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

Intervention Type OTHER

Calls

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

Intervention Type 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

Intervention Type OTHER

Dried blood spot

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

Intervention Type OTHER

Eligibility Criteria

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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
* Already fasting \>13 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Hunter College

New York, New York, United States

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

St. Jude Children's Research Hospital (Data Collection Only)

Memphis, Tennessee, United States

Site Status RECRUITING

Fred Hutchinson Cancer Research Center (Data Collection Only)

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Danielle Friedman, MD

Role: CONTACT

1-833-MSK-KIDS

Chaya Moskowitz, PhD

Role: CONTACT

646-227-3607

Facility Contacts

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Jennifer Ford, PhD

Role: primary

212-396-6690

Danielle Friedman, MD

Role: primary

1-833-MSK-KIDS

Chaya Moskowitz, PhD

Role: backup

646-227-3607

Gregory Armstrong, MD

Role: primary

901-595-5892

Mary Kwok, MD

Role: primary

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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24-250

Identifier Type: -

Identifier Source: org_study_id

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