Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen, Tuebingen, Germany.
Centre of Excellence for Eating Disorders Tuebingen (KOMET), Tuebingen, Germany.
Trials. 2022 Jul 23;23(1):590. doi: 10.1186/s13063-022-06525-0.
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.
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.
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.
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).
儿童和青少年超重和肥胖是当今最严重的健康挑战之一。结构化的减肥计划可以帮助减少严重的健康后果，但证据部分不足。STARKIDS 计划旨在改善其中的一些局限性，旨在为整个家庭提供结构化、逐步的、数字化支持的干预计划。它分为两个干预步骤，跨越 1.5 年，旨在促进超重/肥胖儿童/青少年的健康体重发育，并提高生活质量。
STARKIDS 干预措施通过将其与在儿科实践中接受一次性结构化咨询的对照组进行比较，在一项整群随机研究设计中进行评估。该研究旨在纳入 1000 个来自 100 个儿科实践的超重/肥胖儿童/青少年家庭。主要结局是降低体重指数百分位数和改善儿童/青少年的生活质量，次要结局是指干预的内容，如饮食、身体活动、压力和媒体习惯。所有结局都在三个测量时间点进行测量：（T0）在基线/纳入研究时，（T1）基线+12 个月，这是 STARKIDS 干预的第 1 步结束时，（T2）基线+18 个月，这是 STARKIDS 干预的第 2 步结束时。
逐步的、电子健康支持的 STARKIDS 计划是一个为超重/肥胖儿童/青少年家庭提供的低门槛干预计划。通过概念验证，STARKIDS 为在德国卫生系统中作为儿童/青少年肥胖预防和干预的标准护理工具的实施提供了潜力。
德国临床试验注册处（DRKS）DRKS00022813（世界卫生组织认可的主要登记处）。于 2020 年 11 月 27 日注册（通用试验编号 U1111-1254-9536）。
