Clinical trial · Interventional
Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
NCT06609473CI-TRIAL-00107937CHEFrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
The goal of the Cardiovascular Health Equity Through Food (CHEF) program is to make it easier for participants and families to cook and eat healthy foods during and following childhood cancer treatment with the long-term goal of supporting heart health.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Childhood Cancer Survivors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHEF Intervention Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CHEF Program
- description
- Enrolled participants and caregivers will complete: * Baseline visit and survey * Meeting with a certified benefits counselor by phone or video teleconference * Kitchen equipment delivery * Weekly meal kit deliveries * Monthly grocery support via gift card * Second meeting with a certified benefits counselor * 3-month survey * Final survey and interview with study staff
- interventionNames
- Behavioral: CHEF Intervention Program
Primary outcomes (1)
- measure
- Change in Dietary Quality Score
- timeFrame
- From baseline to 6 months
- description
- The change in mean participant dietary quality from study period T1 (baseline) to study period T3 (month 6), as measured by the Rapid Prime Dietary Quality Score Screener (scored 0-52, higher score indicates higher quality diet).
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Child with any primary cancer diagnosis (non-relapsed, non-secondary malignancy) who has received cancer-directed therapy that includes chemotherapy and/or radiation therapy; * Child is within one of the following time windows: 1. Among those receiving chemotherapy, any time from start of last planned cycle of chemotherapy until 12 months from completion of chemotherapy; 2. Among those receiving radiation therapy alone or radiation and surgery, any time from completion of radiation until 12 months post completion; * Child has 1 or more cardiovascular risk factor (defined as any of: body mass index ≥ 85th percentile; systolic or diastolic blood pressure ≥90th percentile; dyslipidemia \[triglycerides ≥150 mg/dL, total cholesterol ≥200 mg/dL, LDL cholesterol ≥130 mg/dL, HDL cholesterol ≤40 mg/dL\]; impaired glucose metabolism \[fasting glucose ≥100 mg/dL, hemoglobin A1c ≥5.7%\]; anthracycline exposure ≥100 mg/m2; or any radiation exposure to chest, brain, thoracic spine, or total body); * Child is ≤18 years of age at time of enrollment, or over 18 years of age but under medical guardianship; * Parent/guardian screened positive for food insecurity.\* \*Assessed through validated 2-item food insecurity screen. Exclusion Criteria: * Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy; * Foreign national family receiving cancer care as an embassy-pay patient.
References
Publications (0)
Data not yet available
No reference posted for this study.