Let's Play! Healthy Kids After Cancer
- Conditions
- Childhood Acute Lymphoblastic Leukemia in RemissionObesity
- Interventions
- Behavioral: Phone Coaching Program
- Registration Number
- NCT02361047
- Lead Sponsor
- HealthPartners Institute
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phone Coaching Program 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.
- Primary Outcome Measures
Name Time Method Feasibility: Number of participants who complete 8 of 10 intervention sessions 6 months Measured by intervention session completion rates.
Acceptability: Number of participants who report high satisfaction with the intervention 6 months Measured by parent survey of satisfaction with intervention materials and sessions.
Retention: Number of participants who complete 6-month outcome assessments 6 months Measured by completion of the 6-month outcome assessment.
- Secondary Outcome Measures
Name Time Method Change in children's BMI 6 months Staff-measured height and weight
Change in children's physical activity 6 months Measured by ActiGraph accelerometers
Change in children's dietary intake 6 months Measured by Nutrition Data System for Research (NDSR) interview
Change in children's energy level 6 months Measured by questionnaire: PedsQL Multidimensional Fatigue Scale
Change in children's biomarker outcome measures 6 months Measured by serum blood samples
Trial Locations
- Locations (3)
Children's Hospitals and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Masonic Cancer Center, University of Minnesota
🇺🇸Minneapolis, Minnesota, United States