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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., Trial Registration: ClinicalTrials.gov, NCT02374788., (© 2024. The Author(s).)

Background: Many studies have identified key factors affecting the rates of engagement in physical activity in older adults with chronic disease. Environmental conditions, such as weather variations, can present challenges for individuals with chronic diseases, such as type 2 diabetes when engaging in physical activity. However, few studies have investigated the influence of weather on daily steps in people with chronic diseases, especially those with prediabetes and type 2 diabetes., Objective: This study investigated the association between weather variations and daily self-monitored step counts over two years among individuals with prediabetes and type 2 diabetes in Sweden., Methods: The study is a secondary analysis using data from the Sophia Step Study, aimed at promoting physical activity among people with prediabetes and type 2 diabetes, which recruited participants from two urban primary care centers in Stockholm and one rural primary care center in southern Sweden over eight rounds. This study measured physical activity using step counters (Yamax Digiwalker SW200) and collected self-reported daily steps. Environmental factors such as daily average temperature, precipitation, and hours of sunshine were obtained from the Swedish Meteorological and Hydrological Institute. A robust linear mixed-effects model was applied as the analysis method., Results: There was no association found between weather variations and the number of steps taken on a daily basis. The analysis indicated that only 10% of the variation in daily steps could be explained by the average temperature, precipitation, and sunshine hours after controlling for age, gender, and BMI. Conversely, individual factors explained approximately 38% of the variation in the observations., Conclusion: This study revealed that there was no association between weather conditions and the number of daily steps reported by individuals with prediabetes and type 2 diabetes taking part in a physical activity intervention over two years. Despite the weather conditions, women and younger people reported more steps than their male and older counterparts.

Background: This study aimed to identify distinct profiles of physical activity (PA) patterns among individuals with prediabetes or type 2 diabetes participating in a two-year PA trial and to investigate predictors of the profiles., Methods: Data ( n = 168, collected 2013-2020) from the cohort of a randomized trial aimed at increasing PA in individuals with prediabetes and type 2 diabetes were used. PA and sedentary behaviours were assessed by waist-worn ActiGraph GT1M accelerometers at baseline and at 6, 12, 18 and 24 months. Fifteen PA and sedentary variables were entered into a latent class mixed model for multivariate longitudinal outcomes. Multinominal regression analysis modelled profile membership based on baseline activity level, age, gender, BMI, disease status and group randomisation., Results: Two profiles of PA patterns were identified: "Increased activity" ( n = 37, 22%) included participants increasing time in PA and decreasing sedentary time. "No change in activity" ( n = 131, 78%) included participants with no or minor changes. "Increased activity" were younger ( p = 0.003) and more active at baseline ( p = 0.011), compared to "No change in activity". No other predictor was associated with profile membership., Conclusions: A majority of participants maintained PA and sedentary patterns over two years despite being part of a PA intervention. Individuals improving PA patterns were younger and more active at baseline.

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/m 2 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., (© 2021. The Author(s).)

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/m 2 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.

Objectives : To investigate the associations between objectively measured sedentary behavior (SB), light-intensity physical activity (LIPA) and moderate-to-vigorous physical activity (MVPA) and cardiometabolic and endocrine biomarkers, and to estimate the associations of reallocating time from one behavior to another with cardiometabolic and endocrine biomarkers. Methods : Baseline data from participants diagnosed with prediabetes or type 2 diabetes, n = 175, 58% men, mean (SD) age = 64.4 (7.7), recruited to a physical activity intervention was used. Time spent in SB, LIPA and MVPA was measured by accelerometer and transformed into isometric log-ratio coordinates. The associations between time spent in SB, LIPA and MVPA and biomarkers were examined by linear regression models. The change in each outcome of reallocating time between the three behaviors was estimated. Results : The findings show strong positive associations of time spent in MVPA and negative associations of time spent in SB relative to time spent in the other behaviors with sagittal abdominal diameter (SAD) and homeostasis model assessment for insulin resistance (HOMA-IR) and negative associations of time spent in SB with high-density lipoprotein (HDL) cholesterol. Theoretically, reallocation of 19 minutes MVPA to SB or to LIPA was associated with a 17% and 17% larger SAD, 39% and 36% larger HOMA-IR values and 3.3% and 2.3% lower levels of HDL, respectively. Conclusion : In conclusion, our analysis from a time-use perspective supports the current evidence that sedentary time is devastating for the cardiometabolic health. While LIPA probably requires more time, maintaining or increasing time in MVPA are the most important features of the time use behaviors when promoting a favorable cardiometabolic risk profile in adults with prediabetes and type 2 diabetes. Trial registration : ClinicalTrials.gov, NCT02374788. Registered 2 March 2015 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02374788.

Aim: The aim of this study was to investigate the potential associations of reallocating 30 minutes sedentary time in long bouts (>60 min) to sedentary time in non-bouts, light intensity physical activity (LPA) and moderate- to vigorous physical activity (MVPA) with cardiometabolic risk factors in a population diagnosed with prediabetes or type 2 diabetes., Methods: Participants diagnosed with prediabetes and type 2 diabetes (n = 124, 50% men, mean [SD] age = 63.8 [7.5] years) were recruited to the physical activity intervention Sophia Step Study. For this study baseline data was used with a cross-sectional design. Time spent in sedentary behaviors in bouts (>60 min) and non-bouts (accrued in <60 min bouts) and physical activity was measured using the ActiGraph GT1M. Associations of reallocating bouted sedentary time to non-bouted sedentary time, LPA and MVPA with cardiometabolic risk factors were examined using an isotemporal substitution framework with linear regression models., Results: Reallocating 30 minutes sedentary time in bouts to MVPA was associated with lower waist circumference (b = -4.30 95% CI:-7.23, -1.38 cm), lower BMI (b = -1.46 95% CI:-2.60, -0.33 kg/m2) and higher HDL cholesterol levels (b = 0.11 95% CI: 0.02, 0.21 kg/m2. Similar associations were seen for reallocation of sedentary time in non-bouts to MVPA. Reallocating sedentary time in bouts to LPA was associated only with lower waist circumference., Conclusion: Reallocation of sedentary time in bouts as well as non-bouts to MVPA, but not to LPA, was beneficially associated with waist circumference, BMI and HDL cholesterol in individuals with prediabetes and type 2 diabetes. The results of this study confirm the importance of reallocation sedentary time to MVPA.

Background: Physical activity prevents or delays progression of impaired glucose tolerance in high-risk individuals. Physical activity promotion should serve as a basis in diabetes care. It is necessary to develop and evaluate health-promoting methods that are feasible as well as cost-effective within diabetes care. The aim of Sophia Step Study is to evaluate the impact of a multi-component and a single component physical activity intervention aiming at improving HbA1c (primary outcome) and other metabolic and cardiovascular risk factors, physical activity levels and overall health in patients with pre- and type 2 diabetes., Methods/design: Sophia Step Study is a randomized controlled trial and participants are randomly assigned to either a multi-component intervention group (A), a pedometer group (B) or a control group (C). In total, 310 patients will be included and followed for 24 months. Group A participants are offered pedometers and a website to register steps, physical activity on prescription with yearly follow-ups, motivational interviewing (10 occasions) and group consultations (including walks, 12 occasions). Group B participants are offered pedometers and a website to register steps. Group C are offered usual care. The theoretical framework underpinning the interventions is the Health Belief Model, the Stages of Change Model, and the Social Cognitive Theory. Both the multi-component intervention (group A) and the pedometer intervention (group B) are using several techniques for behavior change such as self-monitoring, goal setting, feedback and relapse prevention. Measurements are made at week 0, 8, 12, 16, month 6, 9, 12, 18 and 24, including metabolic and cardiovascular biomarkers (HbA1c as primary health outcome), accelerometry and daily steps. Furthermore, questionnaires were used to evaluate dietary intake, physical activity, perceived ability to perform physical activity, perceived support for being active, quality of life, anxiety, depression, well-being, perceived treatment, perceived stress and diabetes self- efficacy., Discussion: This study will show if a multi-component intervention using pedometers with group- and individual consultations is more effective than a single- component intervention using pedometers alone, in increasing physical activity and improving HbA1c, other metabolic and cardiovascular risk factors, physical activity levels and overall health in patients with pre- and type 2 diabetes., Trial Registration: ClinicalTrials.gov Identifier: NCT02374788 . Registered 28 January 2015.

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 [ABSTRACT FROM AUTHOR]