实施、影响机制以及澳大利亚成年人 Modification of Diet, Exercise and Lifestyle（MODEL）随机对照试验结局中涉及的关键背景因素：混合方法过程评价方案。

Implementation, mechanisms of impact and key contextual factors involved in outcomes of the Modification of Diet, Exercise and Lifestyle (MODEL) randomised controlled trial in Australian adults: protocol for a mixed-method process evaluation.

机构信息

School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia

School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.

出版信息

BMJ Open. 2020 Nov 11;10(11):e036395. doi: 10.1136/bmjopen-2019-036395.

DOI:10.1136/bmjopen-2019-036395

PMID:33177130

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7661373/

Abstract

INTRODUCTION

The Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on 'healthful' improvements to diet and lifestyle. This paper reports the protocol for the process evaluation for the MODEL study.

METHODS AND ANALYSIS

The overall aim of the process evaluation is to understand the processes that took place during participation in the MODEL study trial and which elements were effective or ineffective for influencing 'healthful' behavioural change, and possible ways of improvement to inform wider implementation strategies. A mixed-method approach will be employed with the use of structured questionnaires and semistructured in-depth interviews. All 200 participants enrolled in the trial will undertake the quantitative component of the study and maximum variation sampling will be used to select a subsample for the qualitative component. The sample size for the qualitative component will be determined based on analytical saturation. Interviews will be digitally recorded and transcribed verbatim. Qualitative data will be analysed thematically and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.

ETHICS AND DISSEMINATION

The MODEL study process evaluation has received approval from Edith Cowan University Human Research Ethics Committee (Project Number: 20513 HODGSON). Written informed consent will be obtained from all participants before they are included in the study. The study results will be shared with the individuals and institutions associated with this study as well as academic audiences through peer-reviewed publication and probable presentation at conferences.

TRIAL REGISTRATION NUMBER

ACTRN12618001087246.

摘要

介绍

饮食、运动和生活方式改良（MODEL）研究旨在探讨提供可视化和图像化的高级结构性血管疾病（腹部主动脉钙化）对改善“健康”饮食和生活方式的影响。本文报告了 MODEL 研究的过程评估方案。

方法和分析

该过程评估的总体目标是了解参与者在 MODEL 研究试验中所经历的过程，以及哪些因素对影响“健康”行为改变是有效或无效的，并为更广泛的实施策略提供改进的可能途径。将采用混合方法，使用结构化问卷和半结构化深入访谈。所有 200 名参加试验的参与者将进行研究的定量部分，最大变化抽样将用于定性部分的抽样。定性部分的样本量将根据分析饱和度确定。访谈将进行数字记录并逐字转录。定性数据将根据主题进行分析，并根据《定性研究报告的统一标准》（COREQ）指南进行报告。