Let's Play! Healthy Kids After Cancer

June 7, 2019 updated by: HealthPartners Institute

Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention

This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, accounting for 25% of all childhood malignancies. Treatment of childhood ALL has a high success rate, with long-term event-free survival of >85%. Treatment success, however, has not come without cost. Recognition of long-term health problems related to childhood cancer therapies is growing. Both during and after therapy, children treated for ALL are at risk for fatigue, reduced physical activity, poor dietary intake, and excessive weight gain, which are driven by physiological (chemotherapy-induced) changes and social (home/environmental) factors. The goals of this pilot study are to evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-delivered nutrition and physical activity program to prevent unhealthy weight gain among 60 childhood ALL survivors, 4-10 years of age. Participants will be randomly assigned to either the phone-delivered parent-targeted nutrition and physical activity intervention or a standard-of-care control group. Intervention success will be benchmarked by changes in key weight-related behaviors (physical activity and dietary intake) over the 6-month trial, and initial impact of the intervention on biomarkers of inflammation and oxidative stress, fatigue, and body composition will be examined.

Study Type

Interventional

Enrollment (Actual)

42

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 Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center, University of Minnesota
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

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

4 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 4.0 years and < 11.0 years of age at the time of recruitment
  • Previously diagnosed of ALL and currently in remission
  • Between 1-5 years post completion of chemotherapy
  • BMI ≥ 85 percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2)

Exclusion Criteria:

  • History of cranial radiation therapy
  • History of bone marrow transplant
  • History of relapse of ALL
  • Diagnosis of Down's Syndrome
  • Comorbidities of obesity that require immediate subspecialist referral
  • Significant pulmonary, cardiovascular, orthopedic, or musculoskeletal problems that would, in their oncologist's judgment, limit their ability to participate in physical activity
  • Significant psychiatric or neurologic disorders that would impair compliance with study protocol
  • Current participation in a weight-loss program

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Phone Coaching Program
Participants will receive a nutrition and physical activity phone coaching program, in addition to standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
Behavioral: Phone Coaching Program
Participants in this group will receive a 10-session nutrition and physical activity program delivered via phone by a health behavior coach to promote healthy lifestyle changes. Participants will also receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
NO_INTERVENTION: Standard Care Control
Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Number of participants who complete 8 of 10 intervention sessions
Time Frame: 6 months
Measured by intervention session completion rates.
6 months
Retention: Number of participants who complete 6-month outcome assessments
Time Frame: 6 months
Measured by completion of the 6-month outcome assessment.
6 months
Acceptability: Number of participants who report high satisfaction with the intervention
Time Frame: 6 months
Measured by parent survey of satisfaction with intervention materials and sessions.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in children's physical activity
Time Frame: 6 months
Measured by ActiGraph accelerometers
6 months
Change in children's dietary intake
Time Frame: 6 months
Measured by Nutrition Data System for Research (NDSR) interview
6 months
Change in children's BMI
Time Frame: 6 months
Staff-measured height and weight
6 months
Change in children's biomarker outcome measures
Time Frame: 6 months
Measured by serum blood samples
6 months
Change in children's energy level
Time Frame: 6 months
Measured by questionnaire: PedsQL Multidimensional Fatigue Scale
6 months

Collaborators and Investigators

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

Sponsor

HealthPartners Institute

Collaborators

National Cancer Institute (NCI)
St. Jude Children's Research Hospital
Children's Hospitals and Clinics of Minnesota
Masonic Cancer Center, University of Minnesota

Investigators

  • Principal Investigator: Alicia S Kunin-Batson, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2015

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (ESTIMATE)

February 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A13-175
  • 1R21CA182727-01A1 (NIH)

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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