Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Department of Biosciences and Nutrition, Karolinska Institutet, Stockholm, Sweden.
BMC Public Health. 2019 Jul 15;19(1):945. doi: 10.1186/s12889-019-7161-y.
BACKGROUND: Childhood overweight and obesity is a serious public health issue with an increase being observed in preschool-aged children. Treating childhood obesity is difficult and few countries use standardized treatments. Therefore, there is a need to find effective approaches that are feasible for both health care providers and families. Thus, the overall aim of this study is to assess the acceptance and effectiveness of a parent support program (the More and Less, ML) for the management of overweight and obesity followed by a mobile health (mHealth) program (the MINISTOP application) in a socially diverse population of families. METHODS/DESIGN: A two-arm, parallel design randomized controlled trial in 300 2-to 6-year-old children with overweight and obesity from Romania, Spain and Sweden (n = 100 from each). Following baseline assessments children are randomized into the intervention or control group in a 1:1 ratio. The intervention, the ML program, consists of 10-weekly group sessions which focus on evidence-based parenting practices, followed by the previously validated MINISTOP application for 6-months to support healthy eating and physical activity behaviors. The primary outcome is change in body mass index (BMI) z-score after 9-months and secondary outcomes include: waist circumference, eating behavior (Child Eating Behavior Questionnaire), parenting behavior (Comprehensive Feeding Practices Questionnaire), physical activity (ActiGraph wGT3x-BT), dietary patterns (based on metabolic markers from urine and 24 h dietary recalls), epigenetic and gut hormones (fasting blood samples), and the overall acceptance of the overweight and obesity management in young children (semi-structured interviews). Outcomes are measured at baseline and after: 10-weeks (only BMI z-score, waist circumference), 9-months (all outcomes), 15- and 21-months (all outcomes except physical activity, dietary patterns, epigenetics and gut hormones) post-baseline. DISCUSSION: This study will evaluate a parent support program for weight management in young children in three European countries. To boost the effect of the ML program the families will be supported by an app for 6-months. If the program is found to be effective, it has the potential to be implemented into routine care to reduce overweight and obesity in young children and the app could prove to be a viable option for sustained effects of the care provided. TRIAL REGISTRATION: ClinicalTrials.gov NCT03800823; 11 Jan 2019.
背景:儿童超重和肥胖是一个严重的公共卫生问题,学龄前儿童的肥胖率呈上升趋势。治疗儿童肥胖症很困难,很少有国家使用标准化的治疗方法。因此,需要寻找对医疗保健提供者和家庭都可行的有效方法。因此,本研究的总体目标是评估父母支持计划(More and Less,ML)在管理超重和肥胖方面的接受程度和有效性,然后在罗马尼亚、西班牙和瑞典的社会多样化家庭中使用移动健康(mHealth)计划(MINISTOP 应用程序)。
方法/设计:这是一项在罗马尼亚、西班牙和瑞典的 300 名 2 至 6 岁超重和肥胖儿童中进行的双臂、平行设计随机对照试验(n=100 名来自每个国家)。在基线评估后,儿童以 1:1 的比例随机分为干预组或对照组。干预措施,即 ML 计划,包括 10 周的小组会议,重点是基于证据的育儿实践,然后是之前经过验证的 MINISTOP 应用程序,用于支持 6 个月的健康饮食和身体活动行为。主要结果是 9 个月后体重指数(BMI)z 分数的变化,次要结果包括:腰围、饮食行为(儿童饮食行为问卷)、育儿行为(综合喂养实践问卷)、身体活动(ActiGraph wGT3x-BT)、饮食模式(基于尿液代谢标志物和 24 小时膳食回忆)、表观遗传学和肠道激素(空腹血样)以及幼儿超重和肥胖管理的总体接受度(半结构化访谈)。结果在基线和以下时间点进行测量:10 周(仅 BMI z 分数、腰围)、9 个月(所有结果)、15 个月和 21 个月(除身体活动、饮食模式、表观遗传学和肠道激素外的所有结果)。
讨论:本研究将在三个欧洲国家评估针对幼儿体重管理的父母支持计划。为了增强 ML 计划的效果,家庭将在 6 个月内获得应用程序的支持。如果该计划被证明有效,它有可能被纳入常规护理,以减少幼儿超重和肥胖,并证明该应用程序是提供持续护理效果的可行选择。
试验注册:ClinicalTrials.gov NCT03800823;2019 年 1 月 11 日。
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