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

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 tran...

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Autores principales: Harrison, Cheryce L, Brammall, Bonnie R, Garad, Rhonda, Teede, Helena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9227652/
https://www.ncbi.nlm.nih.gov/pubmed/35679115
http://dx.doi.org/10.2196/33625
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author Harrison, Cheryce L
Brammall, Bonnie R
Garad, Rhonda
Teede, Helena
author_facet Harrison, Cheryce L
Brammall, Bonnie R
Garad, Rhonda
Teede, Helena
author_sort Harrison, Cheryce L
collection PubMed
description 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
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spelling pubmed-92276522022-06-25 OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial Harrison, Cheryce L Brammall, Bonnie R Garad, Rhonda Teede, Helena JMIR Res Protoc Protocol 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 JMIR Publications 2022-06-09 /pmc/articles/PMC9227652/ /pubmed/35679115 http://dx.doi.org/10.2196/33625 Text en ©Cheryce L Harrison, Bonnie R Brammall, Rhonda Garad, Helena Teede. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.06.2022. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Harrison, Cheryce L
Brammall, Bonnie R
Garad, Rhonda
Teede, Helena
OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial
title OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial
title_full OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial
title_fullStr OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial
title_full_unstemmed OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial
title_short OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial
title_sort optimalme intervention for healthy preconception, pregnancy, and postpartum lifestyles: protocol for a randomized controlled implementation effectiveness feasibility trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9227652/
https://www.ncbi.nlm.nih.gov/pubmed/35679115
http://dx.doi.org/10.2196/33625
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