Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-12
SponsorUniversity of Kansas Medical Center
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Primary oncology provider identifies safety concerns regarding the child's participation in the study.
Trial population
Families of youth aged 2-12 years who are newly diagnosed with acute lymphoblastic leukemia.
Trial design
Design model
Family-based
Time perspective
Prospective
Treatments tested in this trial
NOURISH-ALL
BehavioralOur 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.
Treatment groups
46 Participants
are divided into 3 treatment groupsGroup A: Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1)0 interventions
Group B: Aim 1b: Iteratively Refining the NOURISH-ALL Intervention (Year 2)1 intervention
Group C: Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Measured by # enrolled / # eligible
Time frame
Baseline (Week 0)2
Retention Rate
Measured by # completed intervention / # enrolled
Time frame
Post-Intervention (Week 6), Follow-Up (Month 6)3
Intended dose received
Measured by # sessions attended / # sessions offered
Time frame
Post-Intervention (Week 6), Follow-Up (Month 6)Secondary outcomes
1
Child Body Mass Index (BMI)
Measured by child height and weight
Time frame
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)2
Child Physical Activity
Measured by Actigraph wGT3x+ activity monitor
Time frame
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)3
Child Sleep
Measured by Actigraph wGT3x+ activity monitor
Time frame
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)4
Child Dietary Intake
Total calories, % calories from fat, and other nutrition variables will be measured by Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Time frame
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
Children's Mercy Hospital Kansas City
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov