Rombeek Meghan, De Jesus Stefanie, Altamirano-Diaz Luis, Welisch Eva, Prapavessis Harry, Seabrook Jamie A, Norozi Kambiz
Department of Paediatrics, Western University, London Health Sciences Centre, London, Canada.
School of Kinesiology, Western University, London, Canada.
Pilot Feasibility Stud. 2017 Nov 15;3:59. doi: 10.1186/s40814-017-0207-y. eCollection 2017.
Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counseling for weight management offers great potential to appeal to technologically literate youth and can address a large geographical area with minimal burden to participants. This pilot study seeks to examine the influence of a 1-year lifestyle intervention on nutrition and physical activity-related health outcomes in overweight or obese children and adolescents with CHD.
This is a pilot and feasibility study which utilizes a single-arm, prospective design with a goal to recruit 40 overweight and obese patients. The feasibility metrics will evaluate the integrity of the study protocol, data collection and questionnaires, recruitment and consent, and acceptability of the intervention protocol and primary outcome measures. The primary clinical outcome metrics are anthropometry, body composition, and cardiorespiratory exercise capacity. The secondary clinical metrics include quality of life, nutrition and physical activity behavior, lung and muscle function, and cardio-metabolic risk factors. Outcomes are assessed at baseline, 6 months, and 1 year. To date, a total of 36 children and youth (11 girls), aged 7-17 years (mean = 14.4 years), have commenced the intervention. Recruitment for the study was initiated in June 2012 and is currently ongoing.
The information provided in this paper is intended to help researchers and health professionals with the development and evaluation of similar lifestyle intervention programs. Since the application of smartphones to pediatric cardiac health and obesity management is a novel approach, and continued research in this area is warranted, this paper may serve as a foundation for further exploration of this health frontier and inform the development of a broader strategy for obesity management in pediatric cardiology.
This pilot study was retrospectively registered at the www.ClinicalTrials.gov registry as NCT02980393 in November 2016, with the study commencing in May 2012. Study protocol version 15OCT2014.
肥胖和先天性心脏病（CHD）都是影响儿童和青少年长期心血管健康的风险因素。在传统的体重管理生活方式咨询中加入智能移动技术，对于吸引熟悉技术的年轻人具有很大潜力，并且可以在给参与者带来最小负担的情况下覆盖很大的地理区域。这项试点研究旨在探讨为期1年的生活方式干预对患有CHD的超重或肥胖儿童及青少年营养和身体活动相关健康结果的影响。
这是一项试点和可行性研究，采用单臂前瞻性设计，目标是招募40名超重和肥胖患者。可行性指标将评估研究方案、数据收集和问卷、招募和同意过程以及干预方案和主要结局指标的可接受性的完整性。主要临床结局指标是人体测量学、身体成分和心肺运动能力。次要临床指标包括生活质量、营养和身体活动行为、肺和肌肉功能以及心血管代谢风险因素。在基线、6个月和1年时评估结局。迄今为止，共有36名7至17岁（平均 = 14.4岁）的儿童和青少年（11名女孩）开始了干预。该研究于2012年6月开始招募，目前仍在进行中。
本文提供的信息旨在帮助研究人员和卫生专业人员开展和评估类似的生活方式干预项目。由于将智能手机应用于儿童心脏健康和肥胖管理是一种新方法，并且该领域需要持续研究，本文可作为进一步探索这一健康前沿领域的基础，并为儿科心脏病学中更广泛的肥胖管理策略的制定提供参考。
这项试点研究于2016年11月在www.ClinicalTrials.gov注册中心进行回顾性注册，注册号为NCT02980393，研究于2012年5月开始。研究方案版本为2014年10月15日。
