Effects of an e-health enhanced multicomponent outpatient intervention for children and adolescents with overweight or obesity in routine primary care (STARKIDS): a cluster-randomized controlled trial

Summary: Background: Pediatric obesity is a major global public health challenge, associated with increased risk for numerous sequelae, persistence into adulthood, and growing economic burden. STARKIDS is a stepwise, tailored, e-health-enhanced, family-focused intervention in primary care. It integrates nutritional counseling targeting dietary energy density reduction, physical activity promotion, behavioral strategies, and psychosocial support.

Methods

We tested whether STARKIDS improves weight development and quality of life (QoL) compared with usual care. A cluster-randomized controlled trial was conducted in pediatric/family practices enrolling children/adolescents with overweight/obesity. Practices were stratified and block-randomized (no blinding) to STARKIDS or one-time counseling (optimized treatment-as-usual, TAU-O). Outcomes were assessed at baseline, 12, and 18 months. Primary outcomes were changes in BMI z-scores and QoL.