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Mobile Exergaming in Type 2 Diabetes (MOBIGAME)

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ClinicalTrials.gov Identifier: NCT02657018
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Arno Schmidt-Trucksäss, University of Basel

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Diabetes Mellitus, Type 2 Device: MOBIGAME Other: Control Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
MOBIGAME group
Device: MOBIGAME
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.

Active Comparator: Control
Lifestyle counseling group
Other: Control
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.




Primary Outcome Measures :
  1. Change from baseline daily physical activity at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Measured as steps per day.


Secondary Outcome Measures :
  1. Adherence to the intervention [ Time Frame: 24 weeks ]
    Measured as usage log entries (intervention group) and self-reported exercise log entries (control group).


Other Outcome Measures:
  1. Change from baseline self-determination at 24 weeks [ 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.

  2. Change from baseline cardiorespiratory fitness at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Aerobic capacity measured as VO2peak.

  3. Change from baseline six minute walking distance at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Measured via the Six Minute Walk Test

  4. Change from baseline isometric leg strength at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Measured as maximal isometric force and rate of force development.

  5. Change from baseline leg strength endurance at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Assessed as maximum number of repetitions in the Sit-to-Stand Test (STS)

  6. Change from baseline glucose metabolism at 24 weeks [ 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.

  7. Change from baseline inflammatory markers at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Total cholesterol, LDL- and HDL-cholesterol, triglycerides, apolipoprotein B, irisin, adiponectin and interleukin-6

  8. Change from baseline central blood pressure at 24 weeks [ Time Frame: Baseline and 24 weeks ]
  9. Change from baseline pulse wave reflection at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Measured as augmentation index.

  10. Change from baseline arterial stiffness at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Measured as aortic pulse wave velocity.

  11. Change from baseline microvascular function at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Measured as retinal vessel diameters.

  12. Change from baseline health-related quality of life (HRQOL) at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Assessed with score in the 36-item Short Form questionnaire (SF-36).

  13. Change from baseline fatigue at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Measured via the score in the 13-item FACIT Fatigue Scale.

  14. Perceived acceptance of intervention [ Time Frame: 24 weeks ]
    Measured via the Technology Acceptance Model (TAM) questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent as documented by signature
  • Non-insulin-dependent diabetes mellitus (doctor diagnosed)
  • Body Mass Index >25 kg/m2
  • Regular smartphone use during the last year before the study
  • Motivation to participate in the study for its entire duration of 24 weeks

Exclusion Criteria:

  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study
  • Participation in other studies in the last four weeks
  • Systolic blood pressure > 170mmHg, diastolic blood pressure > 100 mmHg
  • Regular physical activity before the study (≥150 min moderate intensity daily PA per week or >1 endurance or strength training session per week of more than 30 min in duration)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657018


Locations
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Switzerland
Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel
Basel, BS, Switzerland, 4052
Sponsors and Collaborators
University of Basel
Swiss National Science Foundation
Investigators
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Principal Investigator: Arno Schmidt-Trucksäss, MD, MA, FESC University of Basel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arno Schmidt-Trucksäss, Prof. Arno Schmidt-Trucksäss MD, MA, FESC, University of Basel
ClinicalTrials.gov Identifier: NCT02657018     History of Changes
Other Study ID Numbers: EKNZ 2015-424
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Overweight
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms