A Study of Time-Restricted Eating in Childhood Cancer Survivors

Purpose

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.

Condition

  • Childhood Cancer Survivors

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
Team members conducting data analysis will be blinded to each participant's assignment.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
Active Comparator
Control Group 		Participants will receive the standard of care electronic handouts through the Way to Health platform, and monthly weight check-ins.
  • 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: Dried blood spot
    Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.

Recruiting Locations

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Danielle Friedman, MD
1-833-MSK-KIDS

St. Jude Children's Research Hospital (Data Collection Only)
Memphis, Tennessee 38105
Contact:
Gregory Armstrong, MD
901-595-5892

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Danielle Friedman, MD
1-833-MSK-KIDS
friedmad@mskcc.org