Trials / Recruiting
RecruitingNCT07009288
A Study of Time-Restricted Eating in Childhood Cancer Survivors
Decreasing Cardiometabolic Risk in Childhood Cancer Survivors: The STRENGTH (Survivors Engaged in Time-Restricted EatiNG After THerapy) Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Children's Oncology Group Heart Health Link | Educational materials on healthy lifestyle behaviors. |
| OTHER | Monthly weights | Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat |
| OTHER | Fasting | (14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention) |
| OTHER | Calls | Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text |
| OTHER | Participant 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 |
| OTHER | Dried blood spot | Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home. |
Timeline
- Start date
- 2025-05-27
- Primary completion
- 2030-05-01
- Completion
- 2031-05-01
- First posted
- 2025-06-06
- Last updated
- 2026-04-02
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT07009288. Inclusion in this directory is not an endorsement.