A Study of Time-Restricted Eating in Childhood Cancer Survivors

Conditions

• Childhood Cancer Survivors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

May 27, 2025

Status verified

May 2026

Primary completion

May 1, 2030

Completion

May 1, 2031

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

• Danielle Friedman, MD
  1-833-MSK-KIDS
  [email protected]
• Chaya Moskowitz, PhD
  646-227-3607

Locations (4)

Find similar trials in New York, NY

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