针对孕前、孕期和产后健康生活方式的OptimalMe干预措施：一项随机对照实施有效性可行性试验方案

OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial.

作者信息

Harrison Cheryce L, Brammall Bonnie R, Garad Rhonda, Teede Helena

机构信息

Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Clayton, Australia.

Endocrine and Diabetes Unit, Monash Health, Clayton, Australia.

出版信息

JMIR Res Protoc. 2022 Jun 9;11(6):e33625. doi: 10.2196/33625.

DOI:10.2196/33625

PMID:35679115

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9227652/

Abstract

BACKGROUND

Reproductive-aged women are a high-risk population group for accelerated weight gain and obesity development, with pregnancy recognized as a critical contributory life-phase. Healthy lifestyle interventions during the antenatal period improve maternal and infant health outcomes, yet translation and implementation of such interventions into real-world health care settings remains limited.

OBJECTIVE

We aim to generate key implementation learnings to inform the feasibility of future scale up and determine the effectiveness of intervention delivery methods on engagement, experience, acceptability, knowledge, risk perception, health literacy, and modifiable weight-related health behaviors in women during preconception, pregnancy, and postpartum periods.

METHODS

This randomized hybrid implementation effectiveness study will evaluate the penetration, reach, feasibility, acceptability, adoption, and fidelity of a healthy lifestyle intervention (OptimalMe) implemented into, and in partnership with, private health care. Individual health outcomes associated with implementation delivery mode, including knowledge, risk perception, health literacy, self-management, and health behaviors, are secondary outcomes. A total of 300 women aged 18 to 44 years, who are not pregnant but wish to conceive within the next 12 months, and with access to the internet will be recruited. All participants will receive the same digital lifestyle intervention, OptimalMe, which is supported by health coaching and text messages during preconception, pregnancy, and postpartum periods. We will use a parallel 2-arm design to compare telephone with videoconference remote delivery methods for health coaching. Methods are theoretically underpinned by the Consolidated Framework for Implementation Research and outcomes based on the Reach, Engagement, Adaptation, Implementation and Maintenance framework.

RESULTS

The study was approved on August 16, 2019 and has been registered. Recruitment commenced in July 2020, and data collection is ongoing. Results are expected to be published in 2022.

CONCLUSIONS

The study's design aligns with best practice implementation research. Results will inform translation of evidence from randomized controlled trials on healthy lifestyle interventions into practice targeting women across preconception, pregnancy, and postpartum periods. Learnings will target consumers, program facilitators, health professionals, services, and policy makers to inform future scale up to ultimately benefit the health of women across these life-phases.

TRIAL REGISTRATION

Australian and New Zealand Clinical Trial Registry ACTRN12620001053910; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378243&isReview=true.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33625.

摘要

背景

育龄妇女是体重加速增加和肥胖发展的高危人群，怀孕被认为是一个关键的促成生命阶段。孕期的健康生活方式干预可改善母婴健康结局，但此类干预措施在现实世界医疗环境中的转化和实施仍然有限。

目的

我们旨在生成关键的实施经验，为未来扩大规模的可行性提供参考，并确定干预实施方法对孕前、孕期和产后妇女的参与度、体验、可接受性、知识、风险认知、健康素养以及与体重相关的可改变健康行为的有效性。

方法

这项随机混合实施效果研究将评估一种健康生活方式干预措施（OptimalMe）在私人医疗保健机构中实施并与之合作的渗透情况、覆盖范围、可行性、可接受性、采用情况和保真度。与实施交付模式相关的个体健康结局，包括知识、风险认知、健康素养、自我管理和健康行为，是次要结局。将招募总共300名年龄在18至44岁之间、未怀孕但希望在未来12个月内怀孕且能上网的女性。所有参与者都将接受相同的数字生活方式干预措施OptimalMe，该措施在孕前、孕期和产后期间由健康指导和短信提供支持。我们将采用平行双臂设计，比较电话与视频会议远程健康指导交付方法。方法在理论上以实施研究的综合框架为基础，结局基于覆盖范围、参与度、适应性、实施和维持框架。