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.
16 affiliations
- 1Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tuebingen, Osianderstraße 5, 72076, Tuebingen, Germany.
- 2German Centre for Mental Health (DZPG), Partner Site Tuebingen, 72076, Tuebingen, Germany.
- 3Institute of Clinical Epidemiology and Applied Biometry, Medical Faculty, University of Tuebingen, Silcherstraße 5, 72076, Tuebingen, Germany.
- 4Department of Sports Medicine, Medical University Hospital Tuebingen, Hoppe-Seyler-Straße 6, 72076, Tuebingen, Germany.
- 5Interfaculty Research Institute for Sport and Physical Activity, Eberhard Karls University of Tuebingen, Tuebingen, Germany.
- 6Institute of Sports Science, University of Tuebingen, Wilhelmstraße 50, 72074, Tuebingen, Germany.
- 7German Sport University, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.
- 8Institute of Media Studies, University of Tuebingen, Wilhelmstraße 124, 72074, Tuebingen, Germany.
- 9Clinic for Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, J5, 68159, Mannheim, Germany.
- 10German Centre for Mental Health (DZPG), Partner Site Mannheim-Heidelberg-Ulm, J5, 68159, Mannheim, Germany.
- 11Center for Clinical Trials, Medical Faculty, University of Tuebingen, Frondsbergstraße 23, 72070, Tuebingen, Germany.
- 12Ministry for Social Affairs, Health and Integration Baden-Württemberg, Department 7 - Health Department, Nordbahnhofstraße 135, 70191, Stuttgart, Germany.
- 13Data Medico GmbH, Hans-Thoma-Straße 72, 69121, Heidelberg, Germany.
- 14Public Health Department of Stuttgart, Schloßstraße 91, 70176, Stuttgart, Germany.
- 15Department of Psychosomatic Medicine and Psychotherapy, Otto von Guericke University Magdeburg, Leipziger Straße 44, 39120, Magdeburg, Germany.
- 16German Center for Mental Health (DZPG), Partner Site Halle-Jena-Magdeburg, Magdeburg, Germany.
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).
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BibTeX
@article{ziser2026effects,
title = {{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.}},
author = {Katrin Ziser and Rebecca Erschens and Stephan Zipfel and Peter Martus and Johann Jacoby and Anne Herschbach and Annalena Wels and Isabelle Mack and Alisa Weiland and Inga Krauß and Constanze Greule and Gorden Sudeck and Ansgar Thiel and Guido Zurstiege and Andreas Hoell and Hans Joachim Salize and Wolfgang Bethge and Monika Ums and Torben Sammet and Maren Reyer and Olaf Schliesing and Katrin E Giel and Stefan Ehehalt and Florian Junne},
journal = {The Lancet regional health. Europe},
year = {2026},
month = oct,
doi = {10.1016/j.lanepe.2026.101897},
url = {https://europepmc.org/article/MED/42927175},
note = {CC BY},
}
RIS
TY - JOUR
TI - 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.
AU - Katrin Ziser
AU - Rebecca Erschens
AU - Stephan Zipfel
AU - Peter Martus
AU - Johann Jacoby
AU - Anne Herschbach
AU - Annalena Wels
AU - Isabelle Mack
AU - Alisa Weiland
AU - Inga Krauß
AU - Constanze Greule
AU - Gorden Sudeck
AU - Ansgar Thiel
AU - Guido Zurstiege
AU - Andreas Hoell
AU - Hans Joachim Salize
AU - Wolfgang Bethge
AU - Monika Ums
AU - Torben Sammet
AU - Maren Reyer
AU - Olaf Schliesing
AU - Katrin E Giel
AU - Stefan Ehehalt
AU - Florian Junne
PY - 2026
DA - 2026/10/14
JO - The Lancet regional health. Europe
DO - 10.1016/j.lanepe.2026.101897
UR - https://europepmc.org/article/MED/42927175
AB - 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).
SN - 2666-7762
ER -