The effects of a lifestyle intervention supported by the InterWalk smart-phone application on increasing physical activity among persons with type 2 diabetes: A parallel-group, randomized trial (Preprint)

BACKGROUND Effective and sustainable implementation of physical activity (PA) in type 2 diabetes (T2D) health care has in general not been successful. Efficacious and contemporary approaches to support PA adherence and adoption are required. OBJECTIVE The primary objective of this study was to investigate the effectiveness of including an app-based (InterWalk) approach into municipality-based rehabilitation to increase moderate-and-vigorous PA (MVPA) across 52 weeks compared with standard care among individuals with T2D. METHODS The study was designed as a parallel-group, randomized trial with 52 weeks intervention and subsequent follow-up for effectiveness (52 weeks from baseline). Participants were recruited between January 2015 and December 2016 and randomly allocated (2:1) into 12 weeks of (1) standard care + InterWalk app-based interval walking training (IWT) (IWT group; n=140), or (2) standard care + the standard exercise program (StC group, n=74). Following 12 weeks, the IWT group was encouraged to maintain InterWalk app-based IWT (3 times per week for 30-60 minutes) and the StC group was encouraged to maintain exercise without structured support. Moreover, half of the IWT group (IWTsupport group, n=54) received additional motivational support following the 12-week program until 52-week follow-up. The primary outcome was change in objectively measured MVPA time (min/day) from baseline to 52-week follow-up. Key secondary outcomes included changes in self-rated physical and mental health-related quality of life (HRQoL), physical fitness, weight and waist circumference. RESULTS Participants had a mean (SD) age of 59.6 (10.6) years of which 128 (59.8%) were men. No changes in MVPA time were observed from baseline to the 52-week follow-up in the StC and IWT groups (least squares means [95% CI]: 0.6 [-4.6 to 5.8] and -0.2 [-3.8 to 3.3], respectively) and no differences were observed between the groups (mean difference [95% CI]: -0.8 [-8.1 to 6.4] min/day, P=.82). Physical HRQoL increased by 4.3 (1.8 to 6.9) SF-12 points more in the IWT group compared with the StC group (Benjamini-Hochberg adjusted P=.007) and waist circumference apparently decreased 2.3 [-4.1 to -0.4] cm more in the IWT group compared with the StC group but weith a Benjamini-Hochberg adjusted P=.06. No between-group differences were observed among the remaining key secondary outcomes. CONCLUSIONS Among individuals with T2D referred to municipality-based lifestyle programs, randomization to InterWalk app-based IWT did not increase objectively measured MVPA time over 52 weeks compared with standard health care, although apparent benefits were observed for physical HRQoL. CLINICALTRIAL www.clinicaltrials.gov (NCT02341690)