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NCT Number: NCT07009288

A Study of Time-Restricted Eating in Childhood Cancer Survivors

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.

Recruiting

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Key information

Conditions

Childhood Cancer Survivors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter College, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Children's Oncology Group Heart Health Link

Other

Educational materials on healthy lifestyle behaviors.

Monthly weights

Other

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

Fasting

Other

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

Calls

Other

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

Participant Questionnaires

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

Other

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

Primary outcomes

  1. Percent change in weight

    Time frame: at 12 months

Secondary outcomes

  1. Change in glucose

    Time frame: up to 12 months

    via dried blood spots

  2. Change in insulin

    Time frame: up to 12 months

    via dried blood spots

  3. Change in HbA1c

    Time frame: up to 12 months

    via dried blood spots

Study contacts

Contact information is provided by the study sponsor or research team.

Chaya Moskowitz, PhD

CONTACT

646-227-3607

Danielle Friedman, MD

CONTACT

[email protected]

1-833-MSK-KIDS

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Decreasing Cardiometabolic Risk in Childhood Cancer Survivors: The STRENGTH (Survivors Engaged in Time-Restricted EatiNG After THerapy) Study

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Jun 6, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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