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

Why clinicians should know about it

• Picked for Family Practice (paper of the day, 26 October 2026): Primary care obesity intervention for children and families
• Picked for Pediatrics and Child Health (paper of the day, 26 October 2026): STARKIDS reduced BMI z‑score over 12 months in overweight youth

Abstract

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).

Abstract as published, via PubMed.