比较不同移动健康应用程序对超重儿童和青少年干预的效果：系统评价与荟萃分析及试验序贯分析的方案。

Comparison of different mobile health applications for intervention in children and adolescent with overweight: a protocol for systematic review with meta-analysis and trial sequential analysis.

机构信息

Design Department, Politecnico di Milano, Milano, MI, Italy.

Department of Child Life and Health, The University of Edinburgh, Edinburgh, UK.

出版信息

BMJ Open. 2020 Dec 7;10(12):e032570. doi: 10.1136/bmjopen-2019-032570.

DOI:10.1136/bmjopen-2019-032570

PMID:33293302

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7722812/

Abstract

INTRODUCTION

Overweight in children is increasing worldwide. Innovative smartphone health applications (mHealth apps) have either sought to deliver single or multi-component interventions for the management of overweight in children. However, the clinical effects of these apps are poorly explored. The objective of the review will be to compare the benefits and harms of different categories of mHealth apps for intervention of overweight in children.

METHODS AND ANALYSIS

We will include randomised clinical trials irrespective of publication type, year, status or language. Children and adolescents between 0 to 18 years will be referred to as children in the remaining part of the paper. Children with all degrees of overweight included obesity and morbidly obese in the remaining part of the paper will be referred to as overweight. We plan to classify different apps according to type of intervention, measurement device, coaching and reward system. The following databases will be used: Cochrane Library, Excerpta Medica database (Embase), PsycINFO, PubMed, IEEE Explore and Web of Science, CINAHL and LILACS. Primary outcomes will be body mass index z-score, quality of life and serious adverse event. Secondary outcomes will be body weight, self-efficacy, anxiety, depression and adverse event not considered serious. Study inclusion, data extraction and bias risk assessment will be conducted independently by at least two authors. We will assess the risk of bias through eight domains and control risks of random errors with Trial Sequential Analysis. The quality of the evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation Tool (GRADE).

ETHICS AND DISSEMINATION

As the protocol is for a systematic reviews, we have not included any patient data and we do not require ethical approval. This review will be published in a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER

CRD42019120266.

摘要

简介

儿童超重现象在全球范围内日益增多。创新型智能手机健康应用程序（移动健康应用程序）旨在提供单一或多组件干预措施，以管理儿童超重问题。然而，这些应用程序的临床效果尚未得到充分探索。本综述的目的是比较不同类别的移动健康应用程序干预儿童超重的益处和危害。

方法和分析

我们将纳入无论出版类型、年份、状态或语言如何的随机临床试验。在本文的其余部分，0 至 18 岁的儿童将被称为儿童。在本文的其余部分，所有超重程度的儿童（包括肥胖和病态肥胖）将被称为超重。我们计划根据干预类型、测量设备、辅导和奖励系统对不同的应用程序进行分类。我们将使用以下数据库：Cochrane 图书馆、Embase 数据库（Excerpta Medica database）、PsycINFO、PubMed、IEEE Explore 和 Web of Science、CINAHL 和 LILACS。主要结局指标将是体重指数 z 分数、生活质量和严重不良事件。次要结局指标将是体重、自我效能、焦虑、抑郁和不被认为严重的不良事件。研究纳入、数据提取和偏倚风险评估将由至少两名作者独立进行。我们将通过八个领域评估偏倚风险，并通过试验序贯分析控制随机误差的风险。证据质量将使用推荐评估、制定和评估工具（Grading of Recommendations Assessment, Development and Evaluation Tool，GRADE）进行评估。