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.

Background: People with prediabetes or type 2 diabetes (T2D) need to be physically active, including moderate-to-vigorous intensity physical activity (MVPA) and light-intensity physical activity (LIPA) and reduce time in sedentary behaviour (SB). Few studies have evaluated the effect of randomised controlled trials taking all movement behaviours into account. This study aimed to investigate the effects of a 2-year pedometer-based intervention in people with prediabetes or T2D on relative time in movement behaviours.

Methods: Secondary analysis of longitudinal data on individuals with prediabetes or T2D from a three-armed randomised controlled trial, the Sophia Step Study, was conducted. The three groups were (1) a multi‑component group (self‑monitoring of steps with a pedometer plus counselling), (2) a single‑component group (self‑monitoring of steps with a pedometer, without counselling), and (3) a standard care group (control). The three behaviours MVPA, LIPA and SB during waking hours were measured with an ActiGraph GT1M accelerometer at baseline, 6, 12, 18 and 24 months. Relative time in MVPA, LIPA and SB for each participant at each time point was calculated and used as outcome measures. Linear mixed models assessed the effect of the intervention over time.

Results: In total 184 participants with mean (SD) age 64.3 (7.6) years and 41% female was included. In the multi-component group, compared to the control group, a significant group-by-time interaction effect for relative time in all three behaviours was found at 6 and 18 months and for MVPA and SB at 24 months. In the single-component group, compared to the control group, an effect occurred in the MVPA and SB behaviours at 6 months and MVPA and LIPA at 24 months. The estimated marginal means ranged from 0.9 to 1.5% of more MVPA, 1.9–3.9% of less LIPA and from 0.5% of less SB to 1.7 more SB in the intervention groups compared to the control group.

Conclusions: The findings show a beneficial effect on all behaviours over time in the two intervention groups compared to the control group. A more pronounced effect occurred in the multi-component intervention compared to the single-component intervention, implicating the importance of counselling in pedometer-based interventions.

Trial registration ClinicalTrials.gov, NCT02374788

Background: This study aimed to explore predictors associated with intermediate (six months) and post-intervention (24 months) increases in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention.

Methods: A secondary analysis was conducted based on data from people with prediabetes or type 2 diabetes from two intervention arms of the randomised controlled trial Sophia Step Study. Daily steps were measured with an ActiGraph GT1M accelerometer. Participants were divided into two groups based on their response to the intervention: Group 1) ≥ 500 increase in daily steps or Group 2) a decrease or < 500 increase in daily steps. Data from baseline and from six- and 24-month follow-ups were used for analysis. The response groups were used as outcomes in a multiple logistic regression together with baseline predictors including self-efficacy, social support, health-related variables, intervention group, demographics and steps at baseline. Predictors were included in the regression if they had a p-value < 0.2 from bivariate analyses.

Results: In total, 83 participants were included. The mean ± SD age was 65.2 ± 6.8 years and 33% were female. At six months, a lower number of steps at baseline was a significant predictor for increasing ≥ 500 steps per day (OR = 0.82, 95% CI 0.69-0.98). At 24 months, women had 79% lower odds of increasing ≥ 500 steps per day (OR = 0.21, 95% CI 0.05-0.88), compared to men. For every year of increase in age, the odds of increasing ≥ 500 steps per day decreased by 13% (OR = 0.87, 95% CI 0.78-0.97). Also, for every step increase in baseline self-efficacy, measured with the Self-Efficacy for Exercise Scale, the odds of increasing ≥ 500 steps per day increased by 14% (OR = 1.14, 95% CI 1.02-1.27).

Conclusions: In the Sophia Step Study pedometer intervention, participants with a lower number of steps at baseline, male gender, lower age or higher baseline self-efficacy were more likely to respond to the intervention with a step increase above 500 steps per day. More knowledge is needed about factors that influence response to pedometer interventions.

OBJECTIVE: To be regularly physically active is of major importance for the health of people with metabolic risk factors. Many of these persons are insufficiently active and in need of support. This study aimed to explore barriers and facilitators perceived by health care professionals' within Swedish primary care in their work to support persons with metabolic risk factors to increase their physical activity.

DESIGN: A qualitative design with focus group discussions was used. The data were analysed using qualitative content analysis with a manifest, inductive approach.

SETTING: Primary health care in five Swedish healthcare regions.

SUBJECTS: Nine physiotherapists, ten physicians and five nurses participated in six digital focus group discussions including two to six participants.

RESULTS: Barriers and facilitators to supporting persons with metabolic risk factors to increase their physical activity were found within four generic categories, where the barriers and facilitators related to each generic category: 'Patient readiness for change', 'Supporting the process of change', 'The professional role', and 'The organisation of primary care'.

CONCLUSION: The findings suggests that barriers and facilitators for supporting patients with metabolic risk factors can be found at several levels within primary care, from individual patient and the health care professionals to the organisational level. In the primary care setting, this should be highlighted when implementing support to increase physical activity in people with metabolic risk factors.KEY POINTSHealth care professionals within primary care are in a position to support people with metabolic risk factors to increase their physical activity.Barriers and facilitators to support the patients should be addressed at several levels within primary care.The study highlights factors on multiple levels such as professional responsibility, organisational prioritisation and resources, and the challenge to motivate behaviour change.