Bernhardsson Susanne, Boman Charlotte, Lundqvist Stefan, Arvidsson Daniel, Börjesson Mats, Larsson Maria E H, Lundh Hannah, Melin Karin, Nilsen Per, Lauruschkus Katarina
Region Västra Götaland, Research, Education, Development and Innovation, Primary Health Care, Gothenburg, Sweden.
Unit of Physiotherapy, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Pilot Feasibility Stud. 2022 Jun 1;8(1):117. doi: 10.1186/s40814-022-01075-3.
Physical inactivity is a main cause of childhood obesity which tracks into adulthood obesity, making it important to address early in life. Physical activity on prescription (PAP) is an evidence-based intervention that has shown good effect on physical activity levels in adults, but has not been evaluated in children with obesity. This project aims to evaluate the prerequisites, determinants, and feasibility of implementing PAP adapted to children with obesity and to explore children's, parents', and healthcare providers' experiences of PAP.
In the first phase of the project, healthcare providers and managers from 26 paediatric clinics in Region Västra Götaland, Sweden, will be invited to participate in a web-based survey and a subset of this sample for a focus group study. Findings from these two data collections will form the basis for adaptation of PAP to the target group and context. In a second phase, this adapted PAP intervention will be evaluated in a clinical study in a sample of approximately 60 children with obesity (ISO-BMI > 30) between 6 and 12 years of age and one of their parents/legal guardians. Implementation process and clinical outcomes will be assessed pre- and post-intervention and at 8 and 12 months' follow-up. Implementation outcomes are the four core constructs of the Normalization Process Theory; coherence, cognitive participation, collective action, and reflexive monitoring; and appropriateness, acceptability, and feasibility of the PAP intervention. Additional implementation process outcomes are recruitment and attrition rates, intervention fidelity, dose, and adherence. Clinical outcomes are physical activity pattern, BMI, metabolic risk factors, health-related quality of life, sleep, and self-efficacy and motivation for physical activity. Lastly, we will explore the perspectives of children and parents in semi-structured interviews. Design and analysis of the included studies are guided by the Normalization Process Theory.
This project will provide new knowledge regarding the feasibility of PAP for children with obesity and about whether and how an evidence-based intervention can be fitted and adapted to new contexts and populations. The results may inform a larger scale trial and future implementation and may enhance the role of PAP in the management of obesity in paediatric health care in Sweden.
ClinicalTrials.gov Identifier: NCT04847271 , registered 14 April 2021.
缺乏身体活动是儿童肥胖的主要原因，儿童肥胖会延续至成年肥胖，因此在生命早期解决这一问题很重要。运动处方（PAP）是一种基于证据的干预措施，已证明对成年人的身体活动水平有良好效果，但尚未在肥胖儿童中进行评估。本项目旨在评估针对肥胖儿童实施PAP的前提条件、决定因素和可行性，并探索儿童、家长和医疗保健提供者对PAP的体验。
在项目的第一阶段，将邀请瑞典韦斯特罗斯-哥德兰地区26家儿科诊所的医疗保健提供者和管理人员参与一项基于网络的调查，并从该样本中抽取一部分进行焦点小组研究。这两项数据收集的结果将为使PAP适应目标群体和背景奠定基础。在第二阶段，将在一项临床研究中对约60名6至12岁的肥胖儿童（国际标准体重指数>30）及其一名家长/法定监护人进行这种经过调整的PAP干预评估。在干预前、干预后以及随访8个月和12个月时评估实施过程和临床结果。实施结果是正常化过程理论的四个核心要素；连贯性、认知参与、集体行动和反思性监测；以及PAP干预的适宜性、可接受性和可行性。其他实施过程结果是招募率和流失率、干预保真度、剂量和依从性。临床结果是身体活动模式、体重指数、代谢风险因素、健康相关生活质量、睡眠以及身体活动的自我效能感和动机。最后，我们将通过半结构化访谈探索儿童和家长的观点。纳入研究的设计和分析以正常化过程理论为指导。
本项目将提供关于PAP对肥胖儿童的可行性以及基于证据的干预措施是否以及如何能够适应新背景和人群的新知识。结果可能为更大规模的试验及未来的实施提供参考，并可能增强PAP在瑞典儿科医疗保健中肥胖管理方面的作用。
ClinicalTrials.gov标识符：NCT04847271，于2021年4月14日注册。
