Let's Play! Healthy Kids After Cancer

HealthPartners Institute

Status: Completed

Conditions: Obesity; Childhood Acute Lymphoblastic Leukemia in Remission

Treatments: Behavioral: Phone Coaching Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02361047

1R21CA182727-01A1 (U.S. NIH Grant/Contract)

A13-175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Phone Coaching Program

Experimental group

Description:

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.

Treatment:

Behavioral: Phone Coaching Program

Standard Care Control

No Intervention group

Description:

Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.