Open Access Journal of Clinical Trials (Jul 2015)

A televideo exercise and nutrition program for children with acute lymphoblastic leukemia in maintenance therapy: design and methods

  • Gibson CA,
  • August KJ,
  • Greene JL,
  • Herrmann SD,
  • Lee J,
  • Harvey SP,
  • Lambourne K,
  • Sullivan DK

Journal volume & issue
Vol. 2015, no. default
pp. 77 – 84

Abstract

Read online

Cheryl A Gibson,1 Keith J August,2 Jerry L Greene,3 Stephen D Herrmann,4 Jaehoon Lee,5 Susan P Harvey,6 Kate Lambourne,3 Debra K Sullivan7 1Department of Internal Medicine, Division of General and Geriatric Medicine, University of Kansas Medical Center, KS, USA; 2Children's Mercy Hospital, MO, USA; 3Department of Health, Sport, and Exercise Sciences, University of Kansas, KS, USA; 4Children's Health Research Center, Sanford Research, SD, USA; 5Institute for Measurement, Methodology, Analysis and Policy, Texas Tech University, TX, USA; 6Center for Research on Learning, University of Kansas, KS, USA; 7Department of Dietetics and Nutrition, University of Kansas Medical Center, KS, USA Abstract: Changes in nutrient intake and decreased exercise resulting from cancer therapies as well as their side effects may be contributing factors in the increased body weight and differences in physical fitness observed in survivors of childhood acute lymphoblastic leukemia (ALL). This article will describe the study protocol for an intervention program designed to improve the physical activity and nutrition behaviors of ALL survivors. Twenty-four children aged between 4 years and 12 years with ALL will be randomized to a 6-month technology-based exercise and nutrition program (TLC4ALLKids) or to enhanced usual care (eUC). The participants randomized to the TLC4ALLKids will participate in weekly, 1-hour coaching sessions on nutrition and physical activity and 1-hour physical activity classes delivered by group video conferencing. Participants will be provided with iPad tablets loaded with video conferencing software and the Healthy Lifestyle Tracking calendar to track daily nutrition and physical activity goals and weight. Both groups will be provided with Fitbit™ Zip to monitor physical activity. To assess feasibility, participant recruitment (achievement of proposed sample size), attendance (per weekly online sessions/assessment sessions), and adherence (number of families at 3 and 6 months) will be evaluated. Outcome measures to assess the intervention will include anthropometrics (weight, height, and waist circumference), physical activity (accelerometry), energy and macronutrient intake (food records), sleep habits (Children's Sleep Habits Questionnaire), and quality of life (Pediatric Quality of Life Inventory) will be obtained at baseline, 3 months, and 6 months. Semi-structured interviews will be used to gather information about ways to improve the program and overcome barriers to participation. If successful, the TLC4ALLKids intervention will provide a means to educate and improve the health behaviors of ALL survivors that can be delivered remotely and conveniently to participants. Keywords: acute lymphoblastic leukemia, enhanced usual care, social cognitive theory