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

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. Trial registration: DRKS00022813. Findings 89 practices were cluster-randomized (44 intervention, 45 TAU-O). Between April 2022 and July 2023, 379 families were assigned to STARKIDS and 232 to TAU-O. 343 and 216 families were included into the intention-to-treat analysis. After 12 months, 114 (33%) participants in the STARKIDS group and 47 (22%) in the TAU-O group achieved a BMI z-score reduction ≥0.2 (risk difference=0.11, 95% CI 0.03, 0.20, p = 0.0256). After 18 months, no group differences in BMI z-score reductions were found ( p = 0.6940). No significant differences in QoL were observed between study arms at either time point among adolescents. Among parents/guardians, a statistically significant between-group difference was observed at 18 months (−2.10, 95% CI −4.13 to −0.06; p = 0.044), though not considered clinically meaningful. No treatment-related serious adverse events were reported. Interpretation STARKIDS improved BMI z-score over 12 months with effects comparable to more intensive programs. The German Federal Joint Committee recommended transferring step 1 into routine care for children/adolescents with obesity. Effects were not sustained at 18 months, indicating a need for adaptations including additional contact hours to reinforce achieved outcomes, followed by a gradual reduction. Funding Innovation Committee of the German Joint Federal Committee (G-BA).