The HIKCUPS trial: a multi-site randomized controlled trial of a combined physical activity skill-development and dietary modification program in overweight and obese children

Background: Childhood obesity is one of the most pressing health issues of our time. Key health organizations have recommended research be conducted on the effectiveness of well-designed interventions to combat childhood obesity that can be translated into a variety of settings. This paper describes the design and methods used in the Hunter Illawarra Kids Challenge Using Parent Support (HIKCUPS) trial, an ongoing multi-site randomized controlled trial, in overweight/obese children comparing the efficacy of three interventions: 1) a parent-centered dietary modification program; 2) a child-centered physical activity skill-development program; and 3) a program combining both 1 and 2 above. Methods/Design: Each intervention consists of three components: i) 10-weekly face-to-face group sessions; ii) a weekly homework component, completed between each face-to-face session and iii) three telephone calls at monthly intervals following completion of the 10-week program. Details of the programs' methodological aspects of recruitment, randomization and statistical analyses are described here a priori. Discussion: Importantly this paper describes how HIKCUPS addresses some of the short falls in the current literature pertaining to the efficacy of child obesity interventions. The HIKCUPS trial is funded by the National Medical Research Council, Australia.