Clinical Trials Directory

Trials / Completed

CompletedNCT02361047

Let's Play! Healthy Kids After Cancer

Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
HealthPartners Institute · Academic / Other
Sex
All
Age
4 Years – 10 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPhone Coaching ProgramParticipants 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.

Timeline

Start date
2015-02-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2015-02-11
Last updated
2019-06-10

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02361047. Inclusion in this directory is not an endorsement.