BACKGROUND
Reproductive aged women are a high-risk population group for accelerated weight gain and obesity development, with pregnancy recognised as a critical contributory life-phase. Healthy lifestyle interventions during the antenatal period improve maternal and infant health outcomes, yet translation and implementation into real-world healthcare settings remains limited.
OBJECTIVE
OptimalMe is a randomised, hybrid implementation effectiveness study of an evidence based healthy lifestyle intervention. Which will evaluate intervention penetration and reach and the feasibility, acceptability, adoption and fidelity of the intervention implemented into, and in partnership with, private healthcare. Secondary outcomes include evaluation of individual health outcomes associated with implementation delivery mode, including knowledge, risk perception, health literacy, self-management and health behaviours.
METHODS
The study design is a parallel, two arm, randomised trial at the level of the individual. Three hundred participants aged 18-44, who are not pregnant, but wish to conceive within the next 12 months at point of recruitment 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 ongoing text messages across preconception, pregnancy and postpartum. Implementation delivery will be tested comparing two remote delivery methods for health coaching including telephone or video conferencing. All methods are theoretically underpinned by the Consolidated Framework for Implementation Research (CFIR) and outcomes based on the Reach, Engagement, Adaptation, Implementation and Maintenance (RE-AIM) and the Penetration, Implementation, Participation, Effectiveness (PIPE) frameworks.
RESULTS
The Monash Health Human Research and Ethics Committee has approved the study (reference: RES-19-0000291A, approved: 16 August 2019) which has been registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12620001053910). The project is supported with funding from Medibank Private Ltd. Recruitment commenced in July 2020 with results expected to be published in 2022.
CONCLUSIONS
Our study design aligns with best practice implementation research, informed by evidence from across efficacy trials, integrated into systematic reviews, meta-analyses and guidelines. Results generated will inform translation of evidence from randomised controlled trials on healthy lifestyle interventions into practice targeting women across preconception, pregnancy and postpartum. 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.ults expected to be published in 2022.
CLINICALTRIAL
ACTRN12620001053910
Cultural Adaptation of Evidence-Based Lifestyle Interventions for African American Men With Prostate Cancer: A Dyadic Approach
