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Abstract Background This aimed to evaluate the effects of self-monitoring of daily steps with or without counselling support on HbA1c, other cardiometabolic risk factors and objectively measured physical activity (PA) during a 2-year intervention in a population with prediabetes or type 2 diabetes. Methods The Sophia Step Study was a three-armed parallel randomised controlled trial. Participants with prediabetes or type 2 diabetes were recruited in a primary care setting. Allocation (1:1:1) was made to a multi-component intervention (self-monitoring of steps with counselling support), a single-component intervention (self-monitoring of steps without counselling support) or standard care. Data were collected for primary outcome HbA1c at baseline and month 6, 12, 18 and 24. Physical activity was assessed as an intermediate outcome by accelerometer (ActiGraph GT1M) for 1 week at baseline and the 6-, 12-, 18- and 24-month follow-up visits. The intervention effects were evaluated by a robust linear mixed model. Results In total, 188 subjects (64, 59, 65 in each group) were included. The mean (SD) age was 64 (7.7) years, BMI was 30.0 (4.4) kg/m2 and HbA1c was 50 (11) mmol/mol, 21% had prediabetes and 40% were female. The dropout rate was 11% at 24 months. Effect size (CI) for the primary outcome (HbA1c) ranged from -1.3 (-4.8 to 2.2) to 1.1 (-2.4 to 4.6) mmol/mol for the multi-component vs control group and from 0.3 (-3.3 to 3.9) to 3.1 (-0.5 to 6.7) mmol/mol for the single-component vs control group. Effect size (CI) for moderate-to-vigorous physical activity ranged from 8.0 (0.4 to 15.7) to 11.1 (3.3 to 19.0) min/day for the multi-component vs control group and from 7.6 (-0.4 to 15.6) to 9.4 (1.4 to 17.4) min/day for the single-component group vs control group. Conclusion This 2-year intervention, including self-monitoring of steps with or without counselling, prevented a decrease in PA but did not provide evidence for improved metabolic control and cardiometabolic risk factors in a population with prediabetes or type 2 diabetes. Trial registration ClinicalTrials.gov, NCT02374788 . Registered 2 March 2015—Retrospectively registered.

Abstract Background Describing implementation features of an intervention is required to compare interventions and to inform policy and best practice. The aim of this study was to conduct a process evaluation of the first 12 months of the Sophia Step Study: a primary care based RCT evaluating a multicomponent (self-monitoring of daily steps plus counseling) and a single component (self-monitoring of steps only) physical activity intervention to standard care on cardiometabolic health. Methods The evaluation was guided by the Medical Research Council Guidance for complex interventions. To describe the implementation communication with the health professionals implementing the interventions, attendance records and tracking of days with self-monitored pedometer-determined steps were used. Change in physical activity behaviour was measured at baseline, 6 and 12 months as daily steps by accelerometry. Results During April 2013 to January 2018 188 participants were randomized and intervened directly after inclusion. Response rate was 49% and drop out was 10%. A majority, 78%, had type 2 diabetes and 22% were diagnosed with prediabetes. Mean [Standard deviation (SD)] body mass index was 30.4 (4.4) kg/m2 and steps per day was 6566 (3086). The interventions were delivered as intended with minor deviation from the protocol and dose received was satisfying for both the multicomponent and single component group. The mean [95% Confidence Interval (CI)] change in daily steps from baseline to 6 months was 941(227, 1655) steps/day for the multicomponent intervention group, 990 (145, 1836) step/day for the single component group and − 506 (− 1118, 107) for the control group. The mean (95% CI) change in daily steps from baseline to 12 months was 31(− 507, 570) steps/day for the multicomponent intervention group, 144 (− 566, 853) step/day for the single component group and − 890 (− 1485, − 294) for the control group. There was a large individual variation in daily steps at baseline as well as in step change in all three groups. Conclusions Applying self-monitoring of steps is a feasible method to implement as support for physical activity in the primary care setting both with and without counseling support. Trial registration ClinicalTrials.gov , NCT02374788 . Registered 2 March 2015.

Abstract Background Globally, the International Classification of Activities for Time-Use Statistics (ICATUS) is one of the most widely used time-use classifications to identify time spent in various activities. Comprehensive 24-h activities that can be extracted from ICATUS provide possible implications for the use of time-use data in relation to activity-health associations; however, these activities are not classified in a way that makes such analysis feasible. This study, therefore, aimed to develop criteria for classifying ICATUS activities into sleep, sedentary behaviour (SB), light physical activity (LPA), and moderate-to-vigorous physical activity (MVPA), based on expert assessment. Method We classified activities from the Trial ICATUS 2005 and final ICATUS 2016. One author assigned METs and codes for wakefulness status and posture, to all subclass activities in the Trial ICATUS 2005. Once coded, one author matched the most detailed level of activities from the ICATUS 2016 with the corresponding activities in the Trial ICATUS 2005, where applicable. The assessment and harmonisation of each ICATUS activity were reviewed independently and anonymously by four experts, as part of a Delphi process. Given a large number of ICATUS activities, four separate Delphi panels were formed for this purpose. A series of Delphi survey rounds were repeated until a consensus among all experts was reached. Results Consensus about harmonisation and classification of ICATUS activities was reached by the third round of the Delphi survey in all four panels. A total of 542 activities were classified into sleep, SB, LPA, and MVPA categories. Of these, 390 activities were from the Trial ICATUS 2005 and 152 activities were from the final ICATUS 2016. The majority of ICATUS 2016 activities were harmonised into the ICATUS activity groups (n = 143). Conclusions Based on expert consensus, we developed a classification system that enables ICATUS-based time-use data to be classified into sleep, SB, LPA, and MVPA categories. Adoption and consistent use of this classification system will facilitate standardisation of time-use data processing for the purpose of sleep, SB and physical activity research, and improve between-study comparability. Future studies should test the applicability of the classification system by applying it to empirical data.