Recruiting

Motivational Sessions & TRE

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07009288

Conditions

Childhood Cancer Survivors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Children's Oncology Group Heart Health Link

Monthly weights

Fasting

Calls

Participant Questionnaires

Study Details

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.

Conditions

Childhood Cancer Survivors

Study ID

NCT07009288

Start date

May 27, 2025

Status verified date

Sep, 2026

Completion date

May 1, 2031

Anticipated

Primary completion date

May 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

active comparator: Control Group

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

Interventions

Children's Oncology Group Heart Health Link

Educational materials on healthy lifestyle behaviors.

Monthly weights

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

Fasting

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

Calls

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

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

Dried blood spot

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

Primary outcome measure

  • Percent change in weight [ Time Frame: at 12 months ]

Central Contacts and Locations

Central contacts

Danielle Friedman, MD

1-833-MSK-KIDSfriedmad@mskcc.org

Chaya Moskowitz, PhD

646-227-3607

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Danielle Friedman, MD

1-833-MSK-KIDS

Chaya Moskowitz, PhD

646-227-3607

Principal Investigator:

Danielle Friedman, MD

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

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Gregory Armstrong, MD

901-595-5892

Principal Investigator:

Gregory Armstrong, MD

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-03.