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Smoking cessation in pregnancy remains a public health priority. Our team used the Behaviour Change Wheel to develop the Midwives and Obstetricians Helping Mothers to Quit smoking (MOHMQuit) intervention with health system, leader (including managers and educators) and clinician components. MOHMQuit addresses a critical evidence to practice gap in the provision of smoking cessation support in antenatal care. It involves nine maternity services in New South Wales in a cluster randomised stepped-wedge controlled trial of effectiveness. This paper describes the design and rationale for the process evaluation of MOHMQuit. The process evaluation aims to assess to what extent and how MOHMQuit is being implemented (acceptability; adoption/uptake; appropriateness; feasibility; fidelity; penetration and sustainability), and the context in which it is implemented, in order to support further refinement of MOHMQuit throughout the trial, and aid understanding and interpretation of the results of the trial.
The process evaluation is an integral part of the stepped-wedge trial. Its design is underpinned by implementation science frameworks and adopts a mixed methods approach. Quantitative evidence from participating leaders and clinicians in our study will be used to produce individual and site-level descriptive statistics. Qualitative evidence of leaders’ perceptions about the implementation will be collected using semistructured interviews and will be analysed descriptively within-site and thematically across the dataset. The process evaluation will also use publicly available data and observations from the research team implementing MOHMQuit, for example, training logs. These data will be synthesised to provide site-level as well as individual-level implementation outcomes.
The study received ethical approval from the Population Health Services Research Ethics Committee for NSW, Australia (Reference 2021/ETH00887). Results will be communicated via the study’s steering committee and will also be published in peer-reviewed journals and presented at conferences.
Australian New Zealand Trials Registry ACTRN12622000167763. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12622000167763.
To examine whether psychosocial needs in diabetes care are associated with carbohydrate counting and if carbohydrate counting is associated with satisfaction with diabetes applications' usability, a randomized crossover trial of 92 adults with type 1 or 2 diabetes requiring insulin therapy tested two top-rated diabetes applications, mySugr and OnTrack Diabetes. Survey responses on demographics, psychosocial needs (perceived competence, autonomy, and connectivity), carbohydrate-counting frequency, and application satisfaction were modeled using mixed-effect linear regressions to test associations. Participants ranged between 19 and 74 years old (mean, 54 years) and predominantly had type 2 diabetes (70%). Among the three tested domains of psychosocial needs, only competence—not autonomy or connectivity—was found to be associated with carbohydrate-counting frequency. No association between carbohydrate-counting behavior and application satisfaction was found. In conclusion, perceived competence in diabetes care is an important factor in carbohydrate counting; clinicians may improve adherence to carbohydrate counting with strategies designed to improve perceived competence. Carbohydrate-counting behavior is complex; its impact on patient satisfaction of diabetes application usability is multifactorial and warrants consideration of patient demographics such as sex as well as application features for automated carbohydrate counting. 
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