Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL (NOURISH-ALL)

July 6, 2026 updated by: Carolyn Bates, PhD, University of Kansas Medical Center

A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The long-term goal of this work is to establish an efficacious family-based health promotion intervention that curbs excessive weight gain among youth with newly diagnosed acute lymphoblastic leukemia (ALL) by integrating support for family coping with stress during the early phases of treatment.

The objectives of the current study are to adapt an existing family-based health promotion intervention, NOURISH-T, to meet the needs of families of youth in the early phases of ALL treatment (NOURISH-ALL) and (2) assess three key components of engagement in preparation for a fully powered efficacy trial.

NOURISH-T is a 6-session family-based health promotion intervention that has demonstrated improved physical activity (PA), dietary intake, and weight among youth who are cancer survivors. Guided by the ORBIT Model of Behavioral Intervention Development, this study will modify NOURISH-T to fit the early ALL treatment context through a multi-stage adaptation and refinement process. Adaptations will incorporate family systems and cognitive behavioral intervention components to support healthy family coping with diagnosis and treatment stress. Additional, patient-centered adaptations will be informed by semi-structured family input around intervention content and delivery.

The central hypothesis is that this rigorous approach to adaptation will yield an intervention that is feasible, acceptable, and engaging for families of youth with ALL. By incorporating tailored strategies for health promotion during the early phases of ALL treatment, the proposed study seeks to shift clinical practice paradigms to prevent weight-related disparities in treatment outcomes.

Hypothesis:

The central hypothesis is that this rigorous approach to adaptation will yield an intervention that is feasible, acceptable, and engaging for families of youth with ALL.

Aims:

AIM 1: To (a) adapt the NOURISH-T intervention to target the early phases of ALL treatment (NOURISH-ALL) and (b) refine this ALL-tailored intervention for optimal feasibility and acceptability from the patient and family perspective. (Years 1-2) Defining the specific needs of families of youth with newly diagnosed ALL is essential to effectively adapting behavior change interventions to the early phases of ALL treatment. Refining interventions for optimal feasibility and acceptability from the family perspective is critical to successful intervention development.

Aim 1a: Intervention Adaptation. The purpose of Aim 1a is to adapt the NOURISH-T intervention to meet the specific needs of families during the early phases of ALL treatment. To achieve this goal, the study will initiate a three-step intervention adaptation process that includes (1) initial integration of cognitive behavioral therapy (CBT) and family systems frameworks, (2) formative assessment with families of youth with ALL, and (3) formative assessment with multidisciplinary experts.

Aim 1b. Refinement to Optimize Feasibility and Acceptability. The purpose of Aim 1b is to adaptively refine NOURISH-ALL through sequential testing with individual families during the early phases of ALL treatment, with the goal of optimizing feasibility and acceptability from the family perspective. In line with the ORBIT model, the study will utilize an adaptive approach, similar to the commonly known "PDSA cycle," to maximize responsivity to individual patient/family feedback. Participants will receive NOURISH-ALL and provide feedback throughout the intervention (i.e., after each session and upon intervention completion), which will be iteratively analyzed and incorporated to improve intervention delivery for the next family.

AIM 2: To conduct an external pilot single-arm trial of NOURISH-ALL focused on three components of engagement. (Years 3-5). 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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kelsey M Dean
  • Phone Number: (816) 652-0065
  • Email: kdean@kumc.edu

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64118
        • Children's Mercy Kansas City
        • Principal Investigator:
          • Keith August, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Study Population

Families of youth aged 2-12 years who are newly diagnosed with acute lymphoblastic leukemia.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)
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).
Behavioral: NOURISH-ALL
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Baseline (Week 0)
Measured by # enrolled / # eligible
Baseline (Week 0)
Retention Rate
Time Frame: Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by # completed intervention / # enrolled
Post-Intervention (Week 6), Follow-Up (Month 6)
Intended dose received
Time Frame: Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by # sessions attended / # sessions offered
Post-Intervention (Week 6), Follow-Up (Month 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Body Mass Index (BMI)
Time Frame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by child height and weight
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Child Physical Activity
Time Frame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by Actigraph wGT3x+ activity monitor
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Child Sleep
Time Frame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by Actigraph wGT3x+ activity monitor
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Family Distress
Time Frame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by Distress Thermometer (DT)
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Family Stress Measures
Time Frame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by Psychosocial Assessment Tool v3.0 (PAT 3.0)
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Child Dietary Intake
Time Frame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Total calories, % calories from fat, and other nutrition variables will be measured by Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Body Composition
Time Frame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by dual energy x-ray absorptiometry (DXA) scan
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Subcutaneous fat
Time Frame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Skinfold thickness measurement
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Body Composition - Bioelectrical Impedance Analysis
Time Frame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by InBody Scale bioelectrical impedance analysis
Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Cancer Institute (NCI)
Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Keith August, MD, Children's Mercy Kansas City
  • Principal Investigator: Carolyn Bates, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002516
  • 1K08CA279877-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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