Kunin‐Batson 2015.
Trial name or title | Healthy kids after cancer: a physical activity and nutrition intervention |
Methods | Study design: randomised controlled trial (RCT) Instrument used to assess fatigue: PedsQL multidimensional fatigue scale Validated questionnaire: yes Cut‐off score or criterion for severe fatigue: NA Time points at which outcome data were collected: 2 time points, start and 6 months after start Inclusion criteria: between 4 and < 11 years of age at the time of recruitment, previously diagnosed with ALL and currently in remission, between 1 ‐ 5 years post‐completion of chemotherapy, BMI ≥ 85 percentile for age and sex or at risk for obesity Exclusion criteria: history of cranial radiation therapy, history of bone marrow transplant, history of relapse of ALL, diagnosis of Down Syndrome, comorbidities of obesity that require immediate subspecialist referral, significant pulmonary, cardiovascular, orthopaedic, or musculoskeletal problems that would limit ability to participate in physical activity, significant psychiatric or neurologic disorders that would impair compliance with study protocol, current participation in a weight‐loss programme |
Participants | NA |
Interventions | NA |
Outcomes | NA |
Starting date | February 2015 |
Contact information | Principal Investigator: Alicia S Kunin‐Batson, PhD University of Minnesota ‐ Clinical and Translational Science Institute |
Notes | clinicaltrials.gov/ct2/show/nct02361047 |