What this study is
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.
What's being tested
- Children's Oncology Group Heart Health Link
Intervention · OTHER
Educational materials on healthy lifestyle behaviors.
- Monthly weights
Intervention · OTHER
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
- Fasting
Intervention · OTHER
(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)
- Calls
Intervention · OTHER
Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text
- Participant Questionnaires
Intervention · 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
Intervention · OTHER
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.
Study details
- Official title
- Decreasing Cardiometabolic Risk in Childhood Cancer Survivors: The STRENGTH (Survivors Engaged in Time-Restricted EatiNG After THerapy) Study
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Childhood Cancer Survivors
- Enrolling
- 300 people
- Starts
- 2025-05-27
- Est. completion
- 2031-05-01
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openHunter College
New York, New York, United States
- Jennifer Ford, PhD · Contact212-396-6690jennifer.ford@hunter.cuny.edu
- Jennifer Ford, PhD · Principal investigator
Not yet recruitingMemorial Sloan Kettering Cancer Center
New York, New York, United States
- Danielle Friedman, MD · Contact1-833-MSK-KIDS
- Chaya Moskowitz, PhD · Contact646-227-3607
- Danielle Friedman, MD · Principal investigator
RecruitingSt. Jude Children's Research Hospital (Data Collection Only)
Memphis, Tennessee, United States
- Gregory Armstrong, MD · Contact901-595-5892
- Gregory Armstrong, MD · Principal investigator
RecruitingFred Hutchinson Cancer Research Center (Data Collection Only)
Seattle, Washington, United States
- Mary Kwok, MD · Contactrykwok@uw.edu
Not yet recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 24-250
Principal investigator
Danielle Friedman, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.