Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL
NOURISH-ALL
A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL
2 other identifiers
interventional
20
1 country
2
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2023
CompletedFirst Posted
Study publicly available on registry
September 22, 2023
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
Study Completion
Last participant's last visit for all outcomes
September 1, 2028
July 8, 2026
October 1, 2025
2 years
September 8, 2023
July 6, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Recruitment Rate
Measured by # enrolled / # eligible
Baseline (Week 0)
Retention Rate
Measured by # completed intervention / # enrolled
Post-Intervention (Week 6), Follow-Up (Month 6)
Intended dose received
Measured by # sessions attended / # sessions offered
Post-Intervention (Week 6), Follow-Up (Month 6)
Secondary Outcomes (9)
Child Body Mass Index (BMI)
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Child Physical Activity
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Child Sleep
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Child Dietary Intake
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Family Stress Measures
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
- +4 more secondary outcomes
Study Arms (1)
Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)
EXPERIMENTALPilot 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).
Interventions
Our NOURISH-ALL intervention will build on this existing NOURISH-T family based behavioral intervention with families of cancer survivors. The intervention, NOURISH-ALL, will adapt these family-based health promotion strategies to the early ALL treatment context.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Primary oncology provider identifies safety concerns regarding the child's participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansas Medical Centerlead
- Children's Mercy Hospital Kansas Citycollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Children's Mercy Kansas City
Kansas City, Missouri, 64118, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Bates, PhD
University of Kansas Medical Center
- PRINCIPAL INVESTIGATOR
Keith August, MD
Children's Mercy Kansas City
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Assistant Professor
Study Record Dates
First Submitted
September 8, 2023
First Posted
September 22, 2023
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
July 8, 2026
Record last verified: 2025-10