Thomsen Louise T, Schmidt-Persson Jesper, Damsgaard Camilla Trab, Krustrup Peter, Grøntved Anders, Krølner Rikke Fredenslund, Nielsen Glen, Lundbye-Jensen Jesper, Skovgaard Thomas, Mølgaard Christian, Hansen Anders Blædel Gottlieb, Hoeeg Didde, Larsen Malte Nejst, Lund Line, Melby Paulina Sander, Pedersen Natascha Holbæk, Troelsen Jens, Nordsborg Nikolai Baastrup, Toft Ulla
Center for Clinical Research and Prevention, Bispebjerg-Frederiksberg Hospital, Frederiksberg, Denmark.
Department of Prevention, Health Promotion and Community Care, Steno Diabetes Center Copenhagen, Herlev, Denmark.
PLoS One. 2024 Dec 5;19(12):e0308142. doi: 10.1371/journal.pone.0308142. eCollection 2024.
Childhood obesity can have significant negative consequences for children's wellbeing and long-term health. Prior school-based interventions to prevent child overweight and obesity have shown limited effects, highlighting the necessity for comprehensive approaches addressing complex drivers of childhood obesity. "Generation Healthy Kids" (GHK) is a multi-setting, multi-component intervention to promote healthy weight development, health and wellbeing in Danish children aged 6-11 years. This protocol describes the GHK main trial, which is a cluster-randomized trial evaluating effectiveness and implementation of the GHK intervention.
Twenty-four schools from the Capital, Zealand and Southern Denmark Regions are randomly allocated 1:1 to intervention or control. The intervention will run for two school years (18-20 months) from October 2023 to June 2025 and will include children in 1st-3rd grade (approx. n = 1,600). The intervention targets multiple settings, including families, schools, after-school clubs, and local communities. Within four focus areas-diet, physical activity, screen media use, and sleep habits-the intervention incorporates several fixed elements, including a school lunch program and three weekly sessions of physical activity at school. Furthermore, building on whole-systems thinking, the intervention encompasses co-created elements developed in collaboration with local stakeholders, e.g. municipalities, sports clubs and supermarkets. This part of the intervention emphasizes building local capacity and engagement to promote child health. Effectiveness data will be collected from participating children and families at baseline, and at the end of school year one (after 6-8 months) and school year two (after 18-20 months). The primary outcome is the change in fat mass, measured by air-displacement plethysmography, from baseline to end-of-study in the intervention group compared to the control group. This is supplemented with numerous secondary outcomes and other prespecified outcomes related to child health and wellbeing. Furthermore, thorough process evaluation will be performed.
GHK combines evidence-based intervention elements targeting multiple settings with a whole-systems approach focusing on capacity building and stakeholder involvement. This novel approach holds promise as an innovative way to promote child health and wellbeing and prevent childhood obesity.
ClinicalTrials.gov: NCT05940675 (registered on 4 July 2023).
儿童肥胖会对儿童的幸福和长期健康产生重大负面影响。此前基于学校的预防儿童超重和肥胖的干预措施效果有限，这凸显了采用综合方法应对儿童肥胖复杂驱动因素的必要性。“健康儿童一代”（GHK）是一项针对丹麦6至11岁儿童促进健康体重发展、健康和幸福的多场所、多组成部分的干预措施。本方案描述了GHK主要试验，这是一项整群随机试验，评估GHK干预措施的有效性和实施情况。
来自首都大区、西兰岛大区和南丹麦大区的24所学校被随机1:1分配到干预组或对照组。干预措施将从2023年10月至2025年6月持续两个学年（18 - 20个月），涵盖一年级至三年级的儿童（约n = 1600名）。该干预措施针对多个场所，包括家庭、学校、课外俱乐部和当地社区。在饮食、体育活动、屏幕媒体使用和睡眠习惯这四个重点领域内，干预措施包含多个固定要素，包括学校午餐计划和每周三次的校内体育活动课程。此外，基于全系统思维，干预措施还包括与当地利益相关者（如市政府、体育俱乐部和超市）合作共同创建的要素。干预措施的这一部分强调建设当地能力和参与度以促进儿童健康。有效性数据将在基线时以及在第一学年末（6 - 8个月后）和第二学年末（18 - 20个月后）从参与的儿童和家庭中收集。主要结局是与对照组相比，干预组从基线到研究结束时通过空气置换体积描记法测量的脂肪量变化。此外还有许多次要结局以及与儿童健康和幸福相关的其他预先指定的结局作为补充。此外，还将进行全面的过程评估。
GHK将针对多个场所的循证干预要素与注重能力建设和利益相关者参与的全系统方法相结合。这种新颖的方法有望成为促进儿童健康和幸福以及预防儿童肥胖的创新方式。
ClinicalTrials.gov：NCT05940675（于2023年7月4日注册）。
