Effectiveness of a Smartphone App to Promote Physical Activity Among Persons With Type 2 Diabetes: Randomized Controlled Trial.

BACKGROUND: Physical activity is well known to have beneficial effects on glycemic control and to reduce risk factors for cardiovascular disease in persons with type 2 diabetes. Yet, successful implementation of lifestyle interventions targeting physical activity in primary care has shown to be difficult. Smartphone apps may provide useful tools to support physical activity. The DiaCert app was specifically designed for integration into primary care and is an automated mobile health (mHealth) solution promoting daily walking. OBJECTIVE: This study aimed to investigate the effect of a 3-month-long intervention promoting physical activity through the use of the DiaCert app among persons with type 2 diabetes in Sweden. Our primary objective was to assess the effect on moderate to vigorous physical activity (MVPA) at 3 months of follow-up. Our secondary objective was to assess the effect on MVPA at 6 months of follow-up and on BMI, waist circumference, hemoglobin A1c, blood lipids, and blood pressure at 3 and 6 months of follow-up. METHODS: We recruited men and women with type 2 diabetes from 5 primary health care centers and 1 specialized center. Participants were randomized 1:1 to the intervention or control group. The intervention group was administered standard care and access to the DiaCert app at baseline and 3 months onward. The control group received standard care only. Outcomes of objectively measured physical activity using accelerometers, BMI, waist circumference, biomarkers, and blood pressure were assessed at baseline and follow-ups. Linear mixed models were used to assess differences in outcomes between the groups. RESULTS: A total of 181 study participants, 65.7% (119/181) men and 34.3% (62/181) women, were recruited into the study and randomized to the intervention (n=93) or control group (n=88). The participants' mean age and BMI were 60.0 (SD 11.4) years and 30.4 (SD 5.3) kg/m2, respectively. We found no significant effect of the intervention (group by time interaction) on MVPA at either the 3-month (ß=1.51, 95% CI -5.53 to 8.55) or the 6-month (ß=-3.53, 95% CI -10.97 to 3.92) follow-up. We found no effect on any of the secondary outcomes at follow-ups, except for a significant effect on BMI at 6 months (ß=0.52, 95% CI 0.20 to 0.84). However, mean BMI did not differ between the groups at the 6-month follow-up. CONCLUSIONS: We found no evidence that persons with type 2 diabetes being randomized to use an app promoting daily walking increased their levels of MVPA at 3 or 6 months' follow-up compared with controls receiving standard care. The effect of the app on BMI was unclear, and we found nothing to support an effect on secondary outcomes. Further research is needed to determine what type of mHealth intervention could be effective to increase physical activity among persons with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03053336; https://clinicaltrials.gov/study/NCT03053336.

The effect of the smartphone app DiaCert on health related quality of life in patients with type 2 diabetes: results from a randomized controlled trial.

BACKGROUND: Type 2 diabetes mellitus is associated with an increased risk of impaired quality of life. Improving health related quality of life (HRQoL) is therefore an important goal in the multimodal management of diabetes. The aim of this study was to evaluate whether the use of the smartphone app DiaCert, that encourage physical activity by promoting daily steps, also impacts HRQoL in patients with type 2 diabetes. METHODS: In this randomized controlled trial, a total of 181 participants with type 2 diabetes were recruited from six health care centers in Stockholm, Sweden. At baseline, participants were randomized 1:1 to the use of the smartphone app DiaCert for a 3 month physical activity intervention in addition to routine care, or to a control group with routine care only. HRQoL was measured using the RAND-36 questionnaire at baseline and at follow-up after 3 months and 6 months. We analysed the HRQoL scores within the intervention and the control groups, respectively, using the Wilcoxon signed-rank test. Between group differences including intervention effect after the 3 month long intervention and after 6 months of follow-up, were assessed using generalized estimating equation models. RESULTS: In total, 166 participants, 108 men and 58 women, with complete baseline data on RAND-36 were included in analysis. The mean age was 60.2 (SD 11.4) years and the mean Body Mass Index 30.3 (SD 5.4) kg/m2. The intervention effect, expressed in terms of the difference in change in HRQoL from baseline to follow-up after 3 months of intervention, showed improvement in the health concept role limitations due to physical health problems (- 16.9; 95% CI - 28.5 to - 5.4), role limitations due to emotional problems (- 13.9; 95% CI - 25.8 to - 2.1), and emotional well-being (- 5.7; 95% CI - 10.4 to - 1.0), in the intervention group compared to the control group. No intervention effect was seen at follow-up after 6 months. CONCLUSIONS: Being randomized to use the smartphone app DiaCert promoting physical activity for 3 months, improved aspects of both physical and emotional HRQoL in patients with type 2 diabetes compared to routine care, but the effect did not last 3 months after the intervention ended. Trial Registration ClinicalTrials.gov Identifier: NCT03053336.

Association between total and leisure time physical activity and risk of myocardial infarction and stroke - a Swedish cohort study.

BACKGROUND: Physical inactivity is a known risk factor for cardiovascular disease, but it is unclear if total and leisure time activity have different impact on the risk of myocardial infarction and stroke. In this cohort, we aimed to investigate the associations between both total and leisure time physical activity in detail, and the risks of myocardial infarction and stroke, both overall and for men and women separately. METHODS: We assessed the association between total and leisure time physical activity on the risk of myocardial infarction and stroke in a cohort of 31,580 men and women through record linkages from 1997-2016. We used Cox proportional hazards regression models to estimate hazard ratios (HR) with 95% confidence intervals (CI) based on detailed self-reported physical activity. In the adjusted analyses, we included age, sex, body mass index, level of education, cigarette smoking, alcohol consumption, diabetes, lipid disturbance and hypertension as potential confounders. RESULTS: We identified 1,621 incident cases of myocardial infarction and 1,879 of stroke. Among men, there was an inverse association between leisure time activity and myocardial infarction in the third tertile compared to the first (HR: 0.78; 95% CI: 0.62-0.98; p for trend = 0.03). We also found an inverse association between leisure time activity and stroke in the third tertile compared to the first (HR: 0.78; 95% CI: 0.61-0.99; p for trend = 0.04), while the corresponding HR for stroke among women was 0.91; 95% CI: 0.74-1.13. We found no significant association between total physical activity and MI (HR: 1.12; 95% CI: 0.93-1.34) or stroke (HR: 1.14 95% CI: 0.94-1.39) comparing the highest to the lowest tertile in men. Women in the highest tertile of total physical activity had a 22% lower risk of myocardial infarction compared to the lowest tertile (HR: 0.78; 95% CI: 0.63-0.97; p for trend = 0.02) and an 8% (95% CI: 0.87-0.98) reduced risk of myocardial infarction with each 1 METh/day increase of leisure time physical activity. CONCLUSION: Total physical activity was inversely associated with the risk of myocardial infarction in women, while leisure time physical activity was inversely associated with the risk of myocardial infarction and stroke in men.