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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
|
| Control Group | Active Comparator | Participants will receive the standard of care electronic handouts through the Way to Health platform, and monthly weight check-ins. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Children's Oncology Group Heart Health Link | Other | Educational materials on healthy lifestyle behaviors. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent change in weight | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose | via dried blood spots | up to 12 months |
| Change in insulin | via dried blood spots | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Friedman, MD | Contact | 1-833-MSK-KIDS | friedmad@mskcc.org | |
| Chaya Moskowitz, PhD | Contact | 646-227-3607 |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Friedman, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter College | Not yet recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
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Team members conducting data analysis will be blinded to each participant's assignment.
| Monthly weights | Other | Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat |
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| Fasting | Other | (14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention) |
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| Calls | Other | Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text |
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| 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 |
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| Dried blood spot | Other | Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home. |
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| Change in HbA1c | via dried blood spots | up to 12 months |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| St. Jude Children's Research Hospital (Data Collection Only) | Recruiting | Memphis | Tennessee | 38105 | United States |
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| Fred Hutchinson Cancer Research Center (Data Collection Only) | Not yet recruiting | Seattle | Washington | 98109 | United States |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
| D059788 | Dried Blood Spot Testing |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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