The evidence base for treating obesity in children is weak and fraught with poorly designed studies with limited follow-up. To address these limitations we undertook HIKCUPS, a high quality 6-month multi-site RCT with three treatment arms and planned 2-year follow-up (1). The RCT compared a parent-centered family lifestyle and diet modification program to a child-centered physical activity skill development program, to doing both. All interventions were performed in a community setting and were designed to be inexpensive and sustainable.
We have completed 1-year follow-up of 165 overweight 5-9 yr olds in two Australian regional cities. The 1-year retention rate was 64%. There were no significant differences in BMI z-score between those who completed or dropped out at either 6 or 12 mo. Using linear mixed model analyses, there were significant improvements in one of the two primary outcomes (BMI z-score), and two secondary outcomes (LDL/HDL cholesterol, energy intake) across all groups from baseline to 12 mo. BMI z-score decreased from 2.81ÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂ±0.71 to 2.45ÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂ±0.69 at 12mo (p<0.001); energy intake decreased from 261ÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂ±108 kJ/kg to 204ÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂ±69 kJ/kg at 12mo (p< 0.001); LDL/HDL decreased from 2.08ÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂ±0.64 to 1.99ÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂ±0.64 at 12mo, p=0.047. Waist circumference (primary outcome) did not change (76.6ÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂ±9.4 cm to 76.2ÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂ±9.7 cm, p=0.11). There were no significant differences between the three groups from baseline to 12 mo. There was no difference in the rate of reduction in BMI z-score between genders. Girls continued to decrease their energy intake from 6 to 12mo whereas boys plateaued, p=0.042.
The three arms of HIKCUPS appear to be equally efficacious when assessed against these variables. Analyses on additional secondary outcomes, including metabolic profile, dietary intake, objectively measured physical activity, motor development, competence, time sedentary, proficiency in sit-to-stand transfers, health-related quality of life and follow-up to 24mo are in progress.
1. Jones RA et al. 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. BMC Public Health 2007, 7 (15).
Funding: HIKCUPS was funded by the National Health & Medical Research Council of Australia. (Clinical Trials No: NCT00107692)