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Completed

NCT Number: NCT02361047

Let's Play! Healthy Kids After Cancer

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.

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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phone Coaching Program

Behavioral

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.

Primary outcomes

  1. Feasibility: Number of participants who complete 8 of 10 intervention sessions

    Time frame: 6 months

    Measured by intervention session completion rates.

  2. Retention: Number of participants who complete 6-month outcome assessments

    Time frame: 6 months

    Measured by completion of the 6-month outcome assessment.

  3. 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.

Secondary outcomes

  1. Change in children's physical activity

    Time frame: 6 months

    Measured by ActiGraph accelerometers

  2. Change in children's dietary intake

    Time frame: 6 months

    Measured by Nutrition Data System for Research (NDSR) interview

  3. Change in children's BMI

    Time frame: 6 months

    Staff-measured height and weight

  4. Change in children's biomarker outcome measures

    Time frame: 6 months

    Measured by serum blood samples

  5. Change in children's energy level

    Time frame: 6 months

    Measured by questionnaire: PedsQL Multidimensional Fatigue Scale

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

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

Registry information

Official study title

Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2015
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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