Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol

Abstract

IntroductionDespite well-established guidelines and benefits to exercise, the majority of pregnant women in the USA fail to meet recommended activity levels. Studies need to determine feasible ways to translate clinical interventions to community settings by engaging pregnant women in widely accessible locations to ensure benefits to more women. The aim of this study is to adapt and determine feasibility, acceptability and fidelity of the research clinic-based Expecting intervention (NCT02125149) with pregnant women with obesity in community settings.Methods and analysisWe will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community. REP provides a four-phase process for implementing evidence-based interventions including collection of feedback from community stakeholders, iterative piloting of the intervention in the community and a process for standardising the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. We will randomise half to receive the community-adapted Expecting intervention (intervention, N=30) and half to receive standard of care (control, N=30). Feasibility and Acceptability of Intervention Measures are primary outcomes as key indicators of feasibility. Secondary outcomes will include the number of intervention sessions completed, the change in the number of minutes of physical activity as measured by accelerometer, as well as change in health indicators from enrolment to time of delivery and 6 months post-delivery (ie, body mass index, blood pressure and total cholesterol).Ethics and disseminationThis study has been approved by the Institutional Review Board (#260132). Findings will be shared with study participants and stakeholder advisors through written summaries and in-person presentations; results will also be shared through presentations at scientific conferences and publications in peer-reviewed journals.Trial registration numberNCT04298125; Pre-results.

Expert Perspectives on Pilot and Feasibility Studies: A Delphi Study and Consolidation of Considerations for Behavioral Interventions

“…In these situations, a PFS may be conducted to establish whether the modifications are appropriate in the new sample/setting. 17 , 18 Adaptations are often made to increase relevance and participant engagement, with the assumption the adaptations would lead to better outcomes in the target populations and settings of eventual interest. 19 , 20 …”

Evidence-Based Quality Improvement (EBQI) in the pre-implementation phase: key steps and activities

“…Cases were examined and compared for key basic features including the number of EBQI meetings held, types of partners included, and modality of meetings. Included case studies ranged in the number of meetings from 2 to 5 ( 26 , 27 , 31 ). On average, included cases were 4 meetings long (Median = 4).…”

“…Most (7/8) cases included all these steps; three included an additional step of making research design decisions (e.g., choosing the control condition; selecting/refining measures). For the third step of selecting EBI adaptations and/or implementation strategies, all cases selected implementation strategies, while 3 also selected adaptations of the EBI ( 27 , 29 , 34 ).…”

“…We have expanded on the Swindle ( 27 ) case to provide a meeting-by-meeting description of an EBQI process for the entirety of the pre-implementation phase, from launch to preparation for implementation. This includes the steps, activities, and outcomes of each individual meeting.…”

“…Continuation of EBQI engagement across implementation phases allows continuation of partnerships formed in pre-implementation. Some cases included in our comparison reconvened EBQI panels after pilot tests to inform further refinement of implementation strategies and research designs as well as community expansion ( 27 ). Consistent with prior literature ( 14 ), we believe partner engagement is critical in and beyond the pre-implementation phase.…”