Clinical trial · Interventional
Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL
A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to conduct a single arm pilot of the NOURISH-ALL (Nourishing Our Understanding of Role modeling to Improve Support and Health in Acute Lymphoblastic Leukemia) intervention focused on three components of participant engagement. This is a single arm intervention study that involves participation in a 6-session family intervention and three time points of multimethod data collection. The primary outcome is participant engagement, measured as recruitment, retention, and intended dose received. This study will be conducted over 5 years in three phases: * Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1) * Aim 1b: Iteratively Refining the NOURISH-ALL Intervention (Year 2) * Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)
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 |
|---|---|---|---|
| ALL, Childhood | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Behavior, Health | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NOURISH-ALL | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)
- description
- Pilot testing key components of engagement is critical to optimizing design and methodology of fully powered efficacy trials. The purpose of Aim 2 is to pilot a single-arm trial of the finalized NOURISH-ALL intervention in a sample of families of youth in the early phases of ALL treatment to assess recruitment, retention, and dose received. Results will directly inform the design of the fully powered randomized control trial to test intervention efficacy (R01 application to be submitted in Year 4).
- interventionNames
- Behavioral: NOURISH-ALL
Primary outcomes (3)
- measure
- Recruitment Rate
- timeFrame
- Baseline (Week 0)
- description
- Measured by # enrolled / # eligible
- measure
- Retention Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Children ages 2-12 years old and their primary caregiver ages 18-90 * Child diagnosed with acute lymphoblastic leukemia (ALL) * Child completed induction phase of therapy and not yet in maintenance phase of therapy * Primary caregiver and child English language proficient * Primary caregiver able to provide permission for child to participate in research * Primary caregiver identifies as being involved with child's oncology care * Primary caregiver lives with child at least 50% of the time * Primary oncology provider confirms child is eligible to participate Exclusion Criteria: * Primary oncology provider identifies safety concerns regarding the child's participation in the study.
References
Publications (0)
Data not yet available