A Study of Time-Restricted Eating in Childhood Cancer Survivors

Memorial Sloan Kettering Cancer Center (MSK)

Status

Enrolling

Conditions

Childhood Cancer Survivors

Treatments

Other: Monthly weights

Other: Participant Questionnaires

Other: Calls

Other: Dried blood spot

Other: Fasting

Other: Children's Oncology Group Heart Health Link

Study type

Interventional

Funder types

Other

Identifiers

NCT07009288

24-250

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Already fasting >13 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

300 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment: