Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | MOBIGAME group |
|
| Control | Active Comparator | Lifestyle counseling group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOBIGAME | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline daily physical activity at 24 weeks | Measured as steps per day. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the intervention | Measured as usage log entries (intervention group) and self-reported exercise log entries (control group). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24 weeks |
| Change from baseline cardiorespiratory fitness at 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arno Schmidt-Trucksäss, MD, MA, FESC | University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel | Basel | Canton of Basel-City | 4052 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31128953 | Derived | Hochsmann C, Muller O, Ambuhl M, Klenk C, Konigstein K, Infanger D, Walz SP, Schmidt-Trucksass A. Novel Smartphone Game Improves Physical Activity Behavior in Type 2 Diabetes. Am J Prev Med. 2019 Jul;57(1):41-50. doi: 10.1016/j.amepre.2019.02.017. Epub 2019 May 22. | |
| 30758293 | Derived | Hochsmann C, Infanger D, Klenk C, Konigstein K, Walz SP, Schmidt-Trucksass A. Effectiveness of a Behavior Change Technique-Based Smartphone Game to Improve Intrinsic Motivation and Physical Activity Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial. JMIR Serious Games. 2019 Feb 13;7(1):e11444. doi: 10.2196/11444. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control | Other | 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. |
|
Aerobic capacity measured as VO2peak. |
| Baseline and 24 weeks |
| Change from baseline six minute walking distance at 24 weeks | Measured via the Six Minute Walk Test | Baseline and 24 weeks |
| Change from baseline isometric leg strength at 24 weeks | Measured as maximal isometric force and rate of force development. | 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) | 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. | 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 | Baseline and 24 weeks |
| Change from baseline central blood pressure at 24 weeks | Baseline and 24 weeks |
| Change from baseline pulse wave reflection at 24 weeks | Measured as augmentation index. | Baseline and 24 weeks |
| Change from baseline arterial stiffness at 24 weeks | Measured as aortic pulse wave velocity. | Baseline and 24 weeks |
| Change from baseline microvascular function at 24 weeks | Measured as retinal vessel diameters. | 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). | Baseline and 24 weeks |
| Change from baseline fatigue at 24 weeks | Measured via the score in the 13-item FACIT Fatigue Scale. | Baseline and 24 weeks |
| Perceived acceptance of intervention | Measured via the Technology Acceptance Model (TAM) questionnaire. | 24 weeks |
| 28264717 | Derived | Hochsmann C, Walz SP, Schafer J, Holopainen J, Hanssen H, Schmidt-Trucksass A. 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. Trials. 2017 Mar 6;18(1):103. doi: 10.1186/s13063-017-1853-3. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |