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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
42
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.
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Feasibility: Number of participants who complete 8 of 10 intervention sessions
Measured by intervention session completion rates.
Time frame: 6 months
Retention: Number of participants who complete 6-month outcome assessments
Measured by completion of the 6-month outcome assessment.
Time frame: 6 months
Acceptability: Number of participants who report high satisfaction with the intervention
Measured by parent survey of satisfaction with intervention materials and sessions.
Time frame: 6 months
Change in children's physical activity
Measured by ActiGraph accelerometers
Time frame: 6 months
Change in children's dietary intake
Measured by Nutrition Data System for Research (NDSR) interview
Time frame: 6 months
Change in children's BMI
Staff-measured height and weight
Time frame: 6 months
Change in children's biomarker outcome measures
Measured by serum blood samples
Time frame: 6 months
Change in children's energy level
Measured by questionnaire: PedsQL Multidimensional Fatigue Scale
Time frame: 6 months
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