The design and quality control of a Multi-site RCT: HIKCUPS (Hunter and Illawarra Kids Challenge Using Parent Support)
The HIKCUPS trial aims to test the efficacy of three lifestyle programs targeted at families of overweight/obese children aged 5.5 to 9 years. This paper describes (1) the study design and (2) the quality control procedures used to minimize bias and maintain internal validity. Children and their parents recruited into the study are randomized into one of three interventions: 1) parent-centred dietary modification program, 2) physical activity skill-development program, and 3) a combination of 1) and 2) above. Children/parents participate in a 10-week face-to-face program and are then actively followed-up for three months. Assessments will be conducted at baseline, 6, 12 and 24 months. The primary outcome is a reduction in adiposity. HIKCUPS addresses some of the shortfalls in the current literature pertaining to the efficacy of childhood obesity intervention strategies by incorporating a large sample size (n=216), an extended follow-up (24 months) and assessments of several secondary outcomes. HIKCUPS employs several quality control procedures namely assessor blinding, written protocols, training, objective evaluation of delivery of program content and debriefing of facilitators thus maximizing validity and reliability of the program delivery and outcome assessments. A range of process evaluations measures are also being collected and initial process evaluation data from the first 3 cohorts will be presented. The study described in this paper is one of the first randomized controlled trials of its kind in Australia and it is hoped that the study results may inform current and future intervention research about the efficacy of conventional weight management strategies. * This project is funded by NHMRC
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