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.