Overview

This trial has been completed.

Conditions childhood acute lymphoblastic leukemia in remission, obesity
Treatment phone coaching program
Sponsor HealthPartners Institute
Collaborator National Cancer Institute (NCI)
Start date February 2015
End date October 2016
Trial size 42 participants
Trial identifier NCT02361047, 1R21CA182727-01A1, A13-175

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
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.
(No Intervention)
Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.

Primary Outcomes

Measure
Feasibility: Number of participants who complete 8 of 10 intervention sessions
time frame: 6 months
Retention: Number of participants who complete 6-month outcome assessments
time frame: 6 months
Acceptability: Number of participants who report high satisfaction with the intervention
time frame: 6 months

Secondary Outcomes

Measure
Change in children's physical activity
time frame: 6 months
Change in children's dietary intake
time frame: 6 months
Change in children's BMI
time frame: 6 months
Change in children's biomarker outcome measures
time frame: 6 months
Change in children's energy level
time frame: 6 months

Eligibility Criteria

Male or female participants from 4 years up to 10 years old.

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

Additional Information

Official title Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention
Principal investigator Alicia S Kunin-Batson, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by HealthPartners Institute.