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

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.

Physical Activity Patterns among Individuals with Prediabetes or Type 2 Diabetes across Two Years—A Longitudinal Latent Class Analysis

“…Intervention group allocation was not predictive of profile group membership in this study, which contradicts the findings from the study of the effects of the intervention [ 22 ]. Thus, the findings of this study highlight that factors other than the intervention were more important for the PA pattern.…”

“…In previous studies, we reported the effects of the Sophia Step Study, an RCT using pedometers and counselling as tools to promote PA in diabetes care [ 21 , 22 ]. The results revealed an intervention effect on the maintenance of moderate to vigorous PA (MVPA) but a weak effect on daily steps [ 22 ]. This current study applies secondary analyses to further explore changes in PA behaviour across all participants.…”

The Effect of Commercial Activity Tracker Based Physical Activity Intervention on Body Composition and Cardiometabolic Health Among Recent Retirees

“…However, apart from our long-term RCT design, we were unable to examine the short-term effects, because we did not measure body composition nor cardiometabolic outcomes during the intervention. Due to lack of changes in physical activity behavior and especially in the levels of moderate-to-vigorous physical activity over 12 months, our findings are in line with 2-years pedometer-based intervention in which no significant increase in daily steps nor improved metabolic health was observed ( Rossen et al, 2021 ). It is likely that changes in moderate-to-vigorous physical activity are needed to have more marked changes in metabolic health.…”

“…Consumer-wearable activity trackers have also been found to increase physical activity and to be associated with improvements in cardiometabolic health, including waist circumference, systolic blood pressure, and low-density lipoprotein cholesterol concentration in middle-aged and older patients with chronic diseases ( Franssen et al, 2020 ). A 2-years pedometer-based intervention prevented decrease in daily steps but did not improve cardiometabolic health in over 60 years old patients with prediabetes or type 2 diabetes ( Rossen et al, 2021 ). However, the long-term effects of activity tracker based physical activity interventions on cardiometabolic health outcomes among older adults are still unknown ( Coughlin and Stewart, 2016 ; Stockwell et al, 2019 ).…”

Reliability and Validity of Common Subjective Instruments in Assessing Physical Activity and Sedentary Behaviour in Chinese College Students

“…However, accurate measurement of physical activity (PA) levels has always been a challenge in research aimed to tailor further intervention for at-risk populations [ 4 , 5 ]. Although objective measurement of accelerometer, a motion sensor which has been proved to be comparable to the “gold standard”—doubly labelled water (DLW) method [ 4 , 5 , 6 , 7 , 8 ], has been used in some epidemiological studies recently [ 9 , 10 , 11 ]. Due to the high cost and time-consuming nature of accelerometers, subjective measurements such as questionnaires and PA logs (PAL) [ 12 ], remain the most feasible solution in large-scale population studies [ 13 , 14 ].…”