FitMum: A process evaluation of the FitMum intervention

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Background

Complex interventions are usually described as interventions containing multiple interacting components and are frequently developed to address health system deficiencies experienced by patients and providers (1,2). Several initiatives have focused on the assessment of validity and presentation of study results (3,4), but only half of the studies published on non-pharmacological interventions in well accepted journals leave information about which components that are included in the interventions (5). It leaves clinicians, patients, and other decision makers left unclear about how to reliably implement the intervention. Evaluation of complex interventions is needed to replicate or build on research findings (6).

To increase the likelihood of successful implementation of interventions and promote dissemination evaluating outcomes other than effectiveness is of great importance. To do this, the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is used to systematically assess key dimensions and robustness of an intervention and the potential for up-scaling and develop in additional settings (7–9). The context will be studied primarily from individual- and intervention-level perspectives by use of both quantitative and qualitative data. The focus will be on the mechanisms that lead the interventions to work or not work and to open the "black box" between providing and receiving or developing and implementing (10–12). Data will be collected alongside the implementation of the two exercise programs.

The research project FitMum will generate evidence about how to implement physical activity in pregnant women’s everyday life by testing the efficacy of two very different exercise programs on physical activity levels during pregnancy. Fewer than four out of ten Danish pregnant women achieve the national recommended level of physical activity (13,14) even though it is well known that physical activity during pregnancy plays an important role for future mothers - and probably also for the next generation - in relation to obesity and related lifestyle disorders, which escalates globally (15,16). The two interventions, structured supervised exercise training and motivational counseling supported by health technology, are designed and developed based on principles for complex interventions to meet the motivators and overcome the specific barriers for physical activity among pregnant women (1,17). 

Project objectives

This PhD project is nested in the FitMum Study and will generate evidence about how to implement physical activity in pregnant women’s everyday life by testing the efficacy of two very different exercise programs on physical activity levels during pregnancy. Besides investigating the efficacy of the FitMum interventions, this project will explore if the FitMum interventions was delivered as intended, whether, how and why the interventions had an impact through participant’s and provider’s perspective and implementation barriers and facilitators of a complex intervention.

FitMum is carried out in collaboration between University of Copenhagen, Nordsjællands Hospital, Technical University of Denmark, Aarhus University and international researchers and brings together an interdisciplinary team of experts. The research project will fill the gap in evidence and practice on how to implement physical activity in pregnant women’s everyday life and provide the public sector with evidence of the effect of physical activity programs that can be made available to all pregnant women, independent of the social determinants of health.

References

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