Let's Play! Healthy Kids After Cancer

Obesity Clinical Trial

Official title:

Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361047
• Other study ID #: A13-175
• Secondary ID: 1R21CA182727-01A
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: October 2016

Study information

• Verified date: June 2019
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Acute Lymphoblastic Leukemia in Remission
• Leukemia, Lymphoid
• Obesity
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• Phone Coaching Program
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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

References & Publications (6)

Cohen J, Wakefield CE, Fleming CA, Gawthorne R, Tapsell LC, Cohn RJ. Dietary intake after treatment in child cancer survivors. Pediatr Blood Cancer. 2012 May;58(5):752-7. doi: 10.1002/pbc.23280. Epub 2011 Aug 17. — View Citation

Mayer EI, Reuter M, Dopfer RE, Ranke MB. Energy expenditure, energy intake and prevalence of obesity after therapy for acute lymphoblastic leukemia during childhood. Horm Res. 2000;53(4):193-9. — View Citation

Ness KK, Armenian SH, Kadan-Lottick N, Gurney JG. Adverse effects of treatment in childhood acute lymphoblastic leukemia: general overview and implications for long-term cardiac health. Expert Rev Hematol. 2011 Apr;4(2):185-97. doi: 10.1586/ehm.11.8. Review. — View Citation

Ness KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209. — View Citation

Rogers PC, Meacham LR, Oeffinger KC, Henry DW, Lange BJ. Obesity in pediatric oncology. Pediatr Blood Cancer. 2005 Dec;45(7):881-91. Review. — View Citation

Sherwood NE, Levy RL, Langer SL, Senso MM, Crain AL, Hayes MG, Anderson JD, Seburg EM, Jeffery RW. Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds. Contemp Clin Trials. 2013 Sep;36(1):228-43. doi: 10.1016/j.cct.2013.06.017. Epub 2013 Jun 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Number of participants who complete 8 of 10 intervention sessions	Measured by intervention session completion rates.	6 months
Primary	Retention: Number of participants who complete 6-month outcome assessments	Measured by completion of the 6-month outcome assessment.	6 months
Primary	Acceptability: Number of participants who report high satisfaction with the intervention	Measured by parent survey of satisfaction with intervention materials and sessions.	6 months
Secondary	Change in children's physical activity	Measured by ActiGraph accelerometers	6 months
Secondary	Change in children's dietary intake	Measured by Nutrition Data System for Research (NDSR) interview	6 months
Secondary	Change in children's BMI	Staff-measured height and weight	6 months
Secondary	Change in children's biomarker outcome measures	Measured by serum blood samples	6 months
Secondary	Change in children's energy level	Measured by questionnaire: PedsQL Multidimensional Fatigue Scale	6 months