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通过动机访谈降低儿科超重和肥胖:AAP PROS 研究网络中一项随机对照试验的研究方案。

Reducing paediatric overweight and obesity through motivational interviewing: study protocol for a randomised controlled trial in the AAP PROS research network.

机构信息

Primary Care Research, American Academy of Pediatrics, Itasca, Illinois, USA

Pediatric Research in Office Settings, American Academy of Pediatrics, Itasca, Illinois, USA.

出版信息

BMJ Open. 2020 Jul 28;10(7):e035720. doi: 10.1136/bmjopen-2019-035720.

Abstract

INTRODUCTION

Primary care remains an underused venue for prevention and management of paediatric overweight and obesity. A prior trial demonstrated a significant impact of paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI) on child body mass index (BMI). The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.

METHODS AND ANALYSIS

This cluster randomised effectiveness trial includes 24 Ped/NPs from 18 paediatric primary care practices that belong to the American Academy of Pediatrics (AAP) national Pediatric Research in Office Settings (PROS) practice-based research network. To date, practices have been randomised (nine to intervention and nine to usual care). Intervention Ped/NPs have been trained in MI, behavioural therapy, billing/coding for weight management and study procedures. Usual care Ped/NPs received training in billing/coding and study procedures only. Children 3- 11 years old with BMI the 85th percentile were identified via electronic health records (EHRs). Parents from intervention practices have been recruited and enrolled. Over about 2 years, these parents are offered approximately 10 MI-based counselling sessions (about four in person sessions with their child's Ped/NP and up to six telephonic sessions with a trained RD). The primary outcome is change in child BMI (defined as per cent from median BMI for age and sex) over the study period. The primary comparison is between eligible children in intervention practices whose parents enrol in the study and all eligible children in usual care practices. Data sources will include EHRs, billing records, surveys and counselling call notes.

ETHICS AND DISSEMINATION

Institutional Review Board approval was obtained from the AAP. All Ped/NPs provided written informed consent, and intervention group parents provided consent and Health Insurance Portability and Accountability Act (HIPAA) authorisation. Findings will be disseminated through peer-reviewed publications, conference presentations and appropriate AAP channels.

TRIAL REGISTRATION NUMBER

NCT03177148; Pre-results.

摘要

简介

初级保健仍然是预防和管理儿童超重和肥胖的未充分利用的场所。先前的试验表明,儿科医生/护士从业者(Ped/NP)和注册营养师(RD)提供的动机访谈(MI)对儿童体重指数(BMI)有显著影响。本文描述的研究将测试这种基于初级保健的 MI 咨询干预的增强版本对儿童 BMI 的有效性。

方法和分析

这项聚类随机有效性试验包括来自 18 个儿科初级保健实践的 24 名 Ped/NP,这些实践属于美国儿科学会(AAP)国家儿科在办公室环境中的研究(PROS)实践基础研究网络。迄今为止,这些实践已经被随机分配(9 个干预组和 9 个常规护理组)。干预组的 Ped/NP 接受了 MI、行为疗法、体重管理计费/编码和研究程序方面的培训。常规护理组的 Ped/NP 仅接受了计费/编码和研究程序方面的培训。通过电子健康记录(EHR)识别出 BMI 位于第 85 百分位的 3-11 岁儿童。干预实践的父母已经被招募并注册。在大约 2 年的时间里,这些父母将接受大约 10 次基于 MI 的咨询会议(大约 4 次与孩子的 Ped/NP 面对面会议和最多 6 次与经过培训的 RD 的电话会议)。主要结果是研究期间儿童 BMI 的变化(定义为年龄和性别中位数 BMI 的百分比)。主要比较是在研究中注册的干预实践中符合条件的儿童与常规护理实践中所有符合条件的儿童之间的比较。数据来源将包括 EHR、计费记录、调查和咨询电话记录。

伦理和传播

AAP 获得了机构审查委员会的批准。所有 Ped/NP 都提供了书面知情同意,干预组的父母提供了同意和健康保险流通与责任法案(HIPAA)授权。研究结果将通过同行评议的出版物、会议演讲和适当的 AAP 渠道进行传播。

试验注册号

NCT03177148;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/42ac/7390232/34c4ef1807ed/bmjopen-2019-035720f01.jpg

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