CLINICAL TRIAL, PHASE III
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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An effective lifestyle intervention in overweight children: findings from a randomized controlled trial on "Obeldicks light".

BACKGROUND & AIMS: Randomized controlled trials (RCT) have demonstrated the effectiveness of lifestyle interventions in obese children. However, the effectiveness of interventions for overweight, but no obese children has not been demonstrated yet by RCTs.

METHODS: A total of 66 overweight (BMI>90th< or =97th percentile) children (mean age 11.5+/-1.6 years, 58% females, mean BMI 23.4+/-1.5kg/m(2)) were randomized into a control group (CG) (n=32; no intervention for a duration of 6 months) or intervention group (IG) (n=34; 6 months intervention "Obeldicks light" based on physical activity, nutrition education, and behaviour counselling). BMI, waist circumference, skinfold thickness, bioimpedance analyses, blood pressure, physical activity based on questionnaires, and three-day-weighed dietary records were determined at baseline (T0) and 6 months (T1) later. Degree of overweight was calculated as BMI-SDS. Comparisons were performed on an intention-to-treat approach.

RESULTS: The drop-out rate was 3% in IG and 16% in CG. At T1, 94% of the children in IG decreased their BMI-SDS and 24% of them were normal weight. The changes between T0 and T1 in BMI-SDS differed significantly (p<0.001) between IG and CG (CG: +0.05+/-0.19 BMI-SDS; IG: -0.26+/-0.22 BMI-SDS). Similar findings were observed for blood pressure, waist circumference, skinfold thickness, and fat mass based on bioimpedance analyses. In the IG, energy, fat and sugar intake decreased significantly between T0 and T1, while no significant changes were observed in the CG.

CONCLUSIONS: The lifestyle intervention was associated with an improvement of dietary patterns and was effective in reducing degree of overweight, fat mass, waist circumference, and blood pressure.

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