title: Mobile Exergaming for Health-Effects of a serious game application for smartphones on physical activity and exercise adherence in type 2 diabetes mellitus-study protocol for a randomized controlled trial.
abstract: Exergaming is a novel approach to increase motivation for regular physical activity (PA) among sedentary individuals such as patients with type 2 diabetes mellitus (T2DM). Because existing exergames do not offer fitness-level adjusted, individualized workouts and are normally stationary (TV bound), thus not enabling PA anywhere and at any time, we developed a smartphone-based, game-like software application (MOBIGAME) specifically designed for middle-aged T2DM patients to induce a healthier, more active lifestyle as part of successful T2DM treatment and management. In a randomized controlled trial we aim to examine whether our smartphone-based game application can lead to increases in daily PA in T2DM patients that are persistent in the mid to long term and whether these increases are greater than those in a control group.
  
  
  
  This study is designed as a randomized controlled trial. We plan to recruit a total of 42 T2DM patients [45-70 years, body mass index (BMI) ≥25 kg/m2, low daily PA, regular smartphone use]. The experimental intervention (duration 24 weeks) includes individualized multidimensional home-based exercise and daily PA promotion administered through MOBIGAME. The control intervention consists of a one-time standard lifestyle counseling including the promotion of baseline activities. The primary outcome is daily PA measured as steps per day. Secondary outcome is exercise adherence measured via the usage data from the participants' smartphones (experimental intervention) and as self-recorded exercise log entries (control intervention). We will test the hypothesis that there will be differences between the experimental and control group with respect to post-interventional daily PA (as well as all other outcomes) using analysis of covariance. For each analysis, an estimate (with 95% confidence interval) of the difference in outcome between both groups will be reported.
  
  
  
  This research will investigate the effectiveness of a novel smartphone-based, game-like software application to be used as a way to promote regular daily PA among inactive T2DM patients. The results of this trial may have important implications for future PA-promoting interventions and provide relevant information for the general transferability of such applications to be used as part of the treatment in other chronic diseases.
  
  
  
  ClinicalTrials.gov, NCT02657018 . Registered on 11 January 2016. Last status update on 3 May 2016. Kofam.ch, SNCTP-number:SNCTP000001652. Registered on 21 January 2016.
authors.affiliation: Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, 4052, Basel, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Höchsmann
authors.affiliation: Swinburne University, Melbourne, Australia.
authors.forename: Steffen P
authors.initials: SP
authors.lastname: Walz
authors.affiliation: Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, 4052, Basel, Switzerland.
authors.forename: Juliane
authors.initials: J
authors.lastname: Schäfer
authors.affiliation: RMIT Europe, Barcelona, Spain.
authors.forename: Jussi
authors.initials: J
authors.lastname: Holopainen
authors.affiliation: Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, 4052, Basel, Switzerland.
authors.forename: Henner
authors.initials: H
authors.lastname: Hanssen
authors.affiliation: Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, 4052, Basel, Switzerland. arno.schmidt-trucksaess@unibas.ch.
authors.forename: Arno
authors.initials: A
authors.lastname: Schmidt-Trucksäss
mesh_terms: D056044:Actigraphy / Q000295:instrumentation; D000368:Aged; D040421:Cell Phone; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D015444:Exercise; D005081:Exercise Therapy / Q000295:instrumentation*; D005260:Female; D000072936:Fitness Trackers; D000070497:Healthy Lifestyle; D006801:Humans; D008297:Male; D008875:Middle Aged; D063731:Mobile Applications; D010349:Patient Compliance; D012107:Research Design; D040242:Risk Reduction Behavior; D012648:Self Care / Q000295:instrumentation*; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome; D018910:Video Games
keywords: Diabetes management; Exercise adherence; Exergaming; Physical activity; Type 2 diabetes