Supporting families to achieve a healthy weight development for their child with overweight/obesity using the STARKIDS intervention: study protocol for a cluster-randomized controlled trial
Katrin Ziser,
Florian Junne,
Anne Herschbach,
Peter Martus,
Johann Jacoby,
Felicitas Stuber,
Zahra Rahmani Azad,
Isabelle Mack,
Alisa Weiland,
Inga Krauß,
Constanze Greule,
Gorden Sudeck,
Lydia Kastner,
Guido Zurstiege,
Andreas Hoell,
Wolfgang Bethge,
Torben Sammet,
Olaf Schliesing,
Stephan Zipfel,
Stefan Ehehalt,
Katrin E. Giel
Affiliations
Katrin Ziser
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen
Florian Junne
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen
Anne Herschbach
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen
Peter Martus
Institute of Clinical Epidemiology and Applied Biometry, Medical Faculty, University of Tuebingen
Johann Jacoby
Institute of Clinical Epidemiology and Applied Biometry, Medical Faculty, University of Tuebingen
Felicitas Stuber
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen
Zahra Rahmani Azad
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen
Isabelle Mack
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen
Alisa Weiland
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen
Inga Krauß
Department of Sports Medicine, Medical University Hospital Tuebingen
Constanze Greule
Department of Sports Medicine, Medical University Hospital Tuebingen
Gorden Sudeck
Institute of Sports Science, University of Tuebingen
Lydia Kastner
Institute of Sports Science, University of Tuebingen
Guido Zurstiege
Insitute of Media Studies, University of Tuebingen
Andreas Hoell
Clinic for Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg
Wolfgang Bethge
Center for Clinical Trials, Medical Faculty, University of Tuebingen
Torben Sammet
Ministry of Social Affairs, Health and Integration Baden-Wuerttemberg
Olaf Schliesing
CES Computer Educations Systems GmbH
Stephan Zipfel
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen
Stefan Ehehalt
Public Health Department of Stuttgart
Katrin E. Giel
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen
Abstract Background Childhood and adolescent overweight and obesity are among the most serious health challenges today. Structured weight reduction programs can be helpful to reduce severe health consequences but evidence is partly scarce. The STARKIDS program aims to improve on some of these limitations and is designed to be a structured, stepwise, digitally supported intervention program for the whole family. It is divided into two intervention steps spanning over 1.5 years and aims at promoting a healthy weight development of children/adolescents with overweight/obesity and an increase in quality of life. Methods The STARKIDS intervention is evaluated in a cluster-randomized study design by comparing it with a control group receiving a one-time structured counselling in the pediatric practice. The study aims to include 1000 families with children/adolescents with overweight/obesity from 100 pediatric practices. The main outcomes are reduction in body mass index percentiles and improvements in children’s/adolescent’s quality of life, secondary outcomes refer to the contents of the intervention such as diet, physical activity, stress, and media habits. All outcomes are measured on three measurement time points: (T0) at baseline/inclusion in the study, (T1) baseline + 12 months which is the end of step 1 of the STARKIDS intervention, and (T2) baseline + 18 months which is the end of step 2 of the STARKIDS intervention. Discussion The stepwise, e-health-supported STARKIDS program is a low-threshold intervention program for families with children/adolescents with overweight/obesity. With the proof of concept, STARKIDS provides the potential to be implemented as a standard care tool for the prevention and intervention of childhood/adolescence obesity in the German health system. Trial registration German Clinical Trials Register (DRKS) DRKS00022813 (acknowledged primary register of the World Health Organization). Registered on 27 November 2020 (Universal Trial Number U1111-1254-9536).
