Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel
Basel, Canton of Basel-City, 4052, Switzerland
NCT Number: NCT02657018
The purpose of this study is to investigate if MOBIGAME (an innovative, mobile phone-based game application) is suitable to increase daily physical activity and physical activity adherence as well as health parameters such as cardiorespiratory fitness, leg strength, glucose metabolism, vascular health and self-determination as well as health related quality of life in the course of a 24-week intervention in comparison to the control group receiving one-time lifestyle counseling.
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Notify Me45 year–70 year
All sexes
Interventional
Not applicable
Basel, Canton of Basel-City, 4052, Switzerland
In recent years, type 2 diabetes mellitus (T2DM) has grown into an emerging pandemic that is a key determinant of morbidity and mortality in both developed and developing countries worldwide. The successful treatment and prevention of T2DM is one of the biggest future health care challenges and most important to manage the enormous socio-economic burden that is associated with T2DM and its various comorbidities. Physical inactivity is known to be one of the most important risk factors for the development of obesity and T2DM. In contrast, increases in physical activity (PA) and fitness can lower the T2DM incidence, improve the patient's glucose metabolism and reduce morbidity and (premature) mortality, independent of body mass index (BMI) or other risk factors. Despite the obvious benefits of regular PA in the treatment and prevention of T2DM, most activity-promoting programs targeting T2DM patients are seldom successful in the long term due to diminishing patient motivation. A novel approach to motivate those individuals that are the least likely to engage in regular PA to be more physically active and adhere to regular PA are active video games or "exergames" that combine PA and video gaming. However, existing exergames do not offer fitness-level adjusted, individualized workouts and are normally stationary and bound to a TV, thus not enabling PA anywhere and at any time. To address these shortcomings, the investigators used sports scientific expertise to develop a smartphone-based, mobile gardening simulation game application, specifically designed for middle-aged T2DM patients, to induce a healthier, more active lifestyle as part of a successful T2DM treatment and management.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mobile phone based game-like software application and platform (MOBIGAME) that includes individualized and structured exercise regimens (endurance, strength, balance and flexibility) that are based on the user's individual fitness evaluation (through established fitness tests) and incorporated into the story line of a gardening simulation game.
One-time standard lifestyle counseling including the promotion of baseline activities of daily life as well as a structured exercise plan including strength and endurance exercises with moderately increasing intensity and duration that is to be implemented autonomously.
Time frame: Baseline and 24 weeks
Measured as steps per day.
Time frame: 24 weeks
Measured as usage log entries (intervention group) and self-reported exercise log entries (control group).
Time frame: Baseline and 24 weeks
Self-determination (intrinsic motivation, perceived competence, perceived choice, perceived usefulness measured via the score in an abridged, 12-item version of the Intrinsic Motivation Inventory.
Time frame: Baseline and 24 weeks
Aerobic capacity measured as VO2peak.
Time frame: Baseline and 24 weeks
Measured via the Six Minute Walk Test
Time frame: Baseline and 24 weeks
Measured as maximal isometric force and rate of force development.
Time frame: Baseline and 24 weeks
Assessed as maximum number of repetitions in the Sit-to-Stand Test (STS)
Time frame: Baseline and 24 weeks
Fasting glucose, glycated hemoglobin (HbA1c), fasting C-peptides, fasting insulin levels and insulin resistance, measured as homeostasis model assessment (HOMA) index.
Time frame: Baseline and 24 weeks
Total cholesterol, LDL- and HDL-cholesterol, triglycerides, apolipoprotein B, irisin, adiponectin and interleukin-6
Time frame: Baseline and 24 weeks
Time frame: Baseline and 24 weeks
Measured as augmentation index.
Time frame: Baseline and 24 weeks
Measured as aortic pulse wave velocity.
Time frame: Baseline and 24 weeks
Measured as retinal vessel diameters.
Time frame: Baseline and 24 weeks
Assessed with score in the 36-item Short Form questionnaire (SF-36).
Time frame: Baseline and 24 weeks
Measured via the score in the 13-item FACIT Fatigue Scale.
Time frame: 24 weeks
Measured via the Technology Acceptance Model (TAM) questionnaire.
University of Basel
Other
Mobile Exergaming for Health - Effects of a Serious Game Application for Smartphones on Physical Activity and Exercise Adherence in Type 2 Diabetes Mellitus (Randomized Controlled Trial)
Acronym: MOBIGAME
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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