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

Overview

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.

Interventions

• Other Children's Oncology Group Heart Health Link
  Educational materials on healthy lifestyle behaviors.
• Other Monthly weights
  Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
• Other Fasting
  (14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)
• Other Calls
  Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text
• 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
• Other 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 measures

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

Secondary outcome measures (3)

• Change in glucose [Time frame: up to 12 months]
• Change in insulin [Time frame: up to 12 months]
• Change in HbA1c [Time frame: up to 12 months]

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)
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

United States · 4 centers

• Hunter College — New York
• Memorial Sloan Kettering Cancer Center — New York
• St. Jude Children's Research Hospital (Data Collection Only) — Memphis
• Fred Hutchinson Cancer Research Center (Data Collection Only) — Seattle

Identifiers

NCT: NCT07009288 · 24-250

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗