Childhood Cancer Survivors
Conditions
Brief summary
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
OTHERChildren's Oncology Group Heart Health Link
Educational materials on healthy lifestyle behaviors.
OTHERMonthly weights
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
OTHERFasting
(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)
OTHERCalls
Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text
OTHERParticipant 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
OTHERDried blood spot
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Team members conducting data analysis will be blinded to each participant's 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in weight | at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in glucose | up to 12 months | via dried blood spots |
| Change in insulin | up to 12 months | via dried blood spots |
| Change in HbA1c | up to 12 months | via dried blood spots |
Countries
United States
Contacts
CONTACTDanielle Friedman, MD
CONTACTChaya Moskowitz, PhD
PRINCIPAL_INVESTIGATORDanielle Friedman, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed