加拿大健康生活轨迹倡议（HeLTI）试验：监测孕前生活方式行为干预保真度的研究方案。

The Canadian Healthy Life Trajectories Initiative (HeLTI) Trial: a study protocol for monitoring fidelity of a preconception-lifestyle behaviour intervention.

机构信息

Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Toronto, ON, M5T 1P8, Canada.

Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.

出版信息

Trials. 2023 Apr 7;24(1):262. doi: 10.1186/s13063-023-07271-7.

DOI:10.1186/s13063-023-07271-7

PMID:37024918

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10079485/

Abstract

BACKGROUND

In evaluating technology-based behaviour change interventions, it is increasingly important to have a monitoring plan for intervention fidelity. It is important to maintain intervention fidelity to ensure that the theory-based intervention that is being tested is what causes the observed changes, particularly for eHealth behaviour change interventions. In this protocol, we outline the intervention fidelity and monitoring protocol for Healthy Life Trajectory Initiative (HeLTI) Canada, a randomized controlled trial evaluating the effect of a preconception-early childhood technology-based intervention delivered by public health nurses among pregnancy-planning women and their partners to optimize child growth and development.

METHODS

The HeLTI Canada fidelity protocol is based on the National Institutes of Health Behaviour Change Consortium (NIH BCC) Treatment Fidelity Framework, outlining the following components of intervention fidelity: study design, provider training, intervention delivery, intervention receipt, and intervention enactment. The intervention fidelity components and associated monitoring strategies were developed to align with the HeLTI Canada approach. Strategies for intervention fidelity monitoring include a pre-post written evaluation of training, standardization of provider training, use and monitoring of activity logs, and intervention session checklists. Possible challenges to intervention fidelity include provider turnover due to the length of the trial and lack of ability to directly monitor participant behaviour change in real-life settings. Details about intervention fidelity monitoring are provided in detail. The study launched in January 2021 and is currently recruiting.

DISCUSSION

Using the NIH BCC Treatment Fidelity Framework, HeLTI Canada has a robust framework for monitoring and reporting intervention fidelity to improve intervention validity, ability to assess intervention effectiveness, and transparency.

TRIAL REGISTRATION

ISRCN ISRCTN13308752 . Registered on February 29, 2019.

摘要

背景

在评估基于技术的行为改变干预措施时，制定干预措施保真度监测计划变得越来越重要。保持干预措施的保真度对于确保正在测试的基于理论的干预措施是引起观察到的变化的原因非常重要，特别是对于电子健康行为改变干预措施。在本方案中，我们概述了加拿大健康人生轨迹倡议（HeLTI）的干预措施保真度和监测方案，这是一项随机对照试验，评估了公共卫生护士在妊娠计划妇女及其伴侣中提供的基于前期-幼儿期技术的干预措施对优化儿童生长和发育的效果。

方法

HeLTI 加拿大保真度方案基于美国国立卫生研究院行为改变联盟（NIH BCC）治疗保真度框架，概述了干预措施保真度的以下组成部分：研究设计、提供者培训、干预措施实施、干预措施接收和干预措施实施。干预措施保真度组成部分和相关监测策略是根据 HeLTI 加拿大方法制定的。干预措施保真度监测策略包括培训前后的书面评估、提供者培训的标准化、活动日志的使用和监测以及干预措施会议清单。干预措施保真度可能面临的挑战包括由于试验时间长和无法直接监测现实生活中参与者行为改变而导致的提供者更替。详细介绍了干预措施保真度监测的细节。该研究于 2021 年 1 月启动，目前正在招募参与者。