An interventional study of MOBIGAME and Control in Overweight, Obesity and Diabetes Mellitus, Type 2, sponsored by University of Basel. Completed at 1 site in Switzerland. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-04-27.
Sponsored by University of Basel · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Basel is the lead sponsor of 61 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
MOBIGAME group
Device: MOBIGAME
Lifestyle counseling group
Other: Control
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.
Change from baseline daily physical activity at 24 weeks
Measured as steps per day.
Time frame: Baseline and 24 weeks
Adherence to the intervention
Measured as usage log entries (intervention group) and self-reported exercise log entries (control group).
Time frame: 24 weeks
Change from baseline self-determination at 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
Change from baseline cardiorespiratory fitness at 24 weeks
Aerobic capacity measured as VO2peak.
Time frame: Baseline and 24 weeks
Change from baseline six minute walking distance at 24 weeks
Measured via the Six Minute Walk Test
Time frame: Baseline and 24 weeks
Change from baseline isometric leg strength at 24 weeks
Measured as maximal isometric force and rate of force development.
Time frame: Baseline and 24 weeks
Change from baseline leg strength endurance at 24 weeks
Assessed as maximum number of repetitions in the Sit-to-Stand Test (STS)
Time frame: Baseline and 24 weeks
Change from baseline glucose metabolism at 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
Change from baseline inflammatory markers at 24 weeks
Total cholesterol, LDL- and HDL-cholesterol, triglycerides, apolipoprotein B, irisin, adiponectin and interleukin-6
Time frame: Baseline and 24 weeks
Change from baseline central blood pressure at 24 weeks
Time frame: Baseline and 24 weeks
Change from baseline pulse wave reflection at 24 weeks
Measured as augmentation index.
Time frame: Baseline and 24 weeks
Change from baseline arterial stiffness at 24 weeks
Measured as aortic pulse wave velocity.
Time frame: Baseline and 24 weeks
Change from baseline microvascular function at 24 weeks
Measured as retinal vessel diameters.
Time frame: Baseline and 24 weeks
Change from baseline health-related quality of life (HRQOL) at 24 weeks
Assessed with score in the 36-item Short Form questionnaire (SF-36).
Time frame: Baseline and 24 weeks
Change from baseline fatigue at 24 weeks
Measured via the score in the 13-item FACIT Fatigue Scale.
Time frame: Baseline and 24 weeks
Perceived acceptance of intervention
Measured via the Technology Acceptance Model (TAM) questionnaire.
Time frame: 24 weeks
Plan to share: No
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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