Process Evaluation of the Sophia Step Study-A Primary Care Based Three-Armed Randomized Controlled Trial Using Self-Monitoring of Steps With and Without Counseling in Prediabetes and Type 2 Diabetes

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 From April 2013 to January 2018 188 participants were randomized. Response rate was 49% and drop out was 10%. 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. While physical activity levels increased after 6 months, maintenance of physical activity is a more realistic expectation in the long term. Physical activity behavior varies among individuals and support for physical activity should be tailored to the person. Trial registration ClinicalTrials.gov, NCT02374788. Registered 2 March 2015 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02374788

Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes—the Sophia Step Study

“…The response rate of invited and eligible individuals was 49%. A process evaluation with details on the context, reasons for declining and adherence to the intervention has been published elsewhere [20]. Figure 1 depicts the number of participants recruited, excluded, declined, consented and dropouts per intervention group, as well as reasons for exclusion and termination.…”

“…Although of varying lengths and support intensity, other similar trials reported superior effects in intervention groups receiving step counting and counselling versus step counting alone [44][45][46]. A process evaluation of the Sophia Step Study has been undertaken, providing details of the intervention delivery and context, as well as evidence for feasibility and a high degree of reach of the interventions [20]. Thus, the lack of intervention effect in this study cannot be explained by unsuccessful intervention delivery.…”

“…Details and theoretical framework of the 2-year intervention are described in the study protocol [18]. The fidelity of the intervention is outlined in a process evaluation [20]. Participants in the two intervention groups were offered step counters (Yamax Digiwalker SW 200: Yamax Corporation, Tokyo, Japan) and directed to a website for self-monitoring of steps [21].…”

A Review on Glycemic Control in Type 2 Diabetes Mellitus by Arm Ergometer Exercise

“…The randomised controlled trial (RCT) of the first year of the Sophia Step Study measured the change in physical and behavioral activity at a baseline of 6 and 12 months by accelerometry as daily steps. This was the three-armed RCT study assessing pedometers and the tools for self-considering of stepping containing and excluding by monitoring the health care professionals on cardiac condition and getting HbA1c as a primary outcome evaluated pre and post-study [22].…”