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Mobile Exergaming in Type 2 Diabetes (MOBIGAME)

Primary Purpose

Overweight, Obesity, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MOBIGAME
Control
Sponsored by
University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

MOBIGAME group

Lifestyle counseling group

Outcomes

Primary Outcome Measures

Change from baseline daily physical activity at 24 weeks
Measured as steps per day.

Secondary Outcome Measures

Adherence to the intervention
Measured as usage log entries (intervention group) and self-reported exercise log entries (control group).

Full Information

First Posted
January 11, 2016
Last Updated
April 26, 2018
Sponsor
University of Basel
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02657018
Brief Title
Mobile Exergaming in Type 2 Diabetes
Acronym
MOBIGAME
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Basel
Collaborators
Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
MOBIGAME group
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Lifestyle counseling group
Intervention Type
Device
Intervention Name(s)
MOBIGAME
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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 Measure Information:
Title
Change from baseline daily physical activity at 24 weeks
Description
Measured as steps per day.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Adherence to the intervention
Description
Measured as usage log entries (intervention group) and self-reported exercise log entries (control group).
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline self-determination at 24 weeks
Description
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
Title
Change from baseline cardiorespiratory fitness at 24 weeks
Description
Aerobic capacity measured as VO2peak.
Time Frame
Baseline and 24 weeks
Title
Change from baseline six minute walking distance at 24 weeks
Description
Measured via the Six Minute Walk Test
Time Frame
Baseline and 24 weeks
Title
Change from baseline isometric leg strength at 24 weeks
Description
Measured as maximal isometric force and rate of force development.
Time Frame
Baseline and 24 weeks
Title
Change from baseline leg strength endurance at 24 weeks
Description
Assessed as maximum number of repetitions in the Sit-to-Stand Test (STS)
Time Frame
Baseline and 24 weeks
Title
Change from baseline glucose metabolism at 24 weeks
Description
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
Title
Change from baseline inflammatory markers at 24 weeks
Description
Total cholesterol, LDL- and HDL-cholesterol, triglycerides, apolipoprotein B, irisin, adiponectin and interleukin-6
Time Frame
Baseline and 24 weeks
Title
Change from baseline central blood pressure at 24 weeks
Time Frame
Baseline and 24 weeks
Title
Change from baseline pulse wave reflection at 24 weeks
Description
Measured as augmentation index.
Time Frame
Baseline and 24 weeks
Title
Change from baseline arterial stiffness at 24 weeks
Description
Measured as aortic pulse wave velocity.
Time Frame
Baseline and 24 weeks
Title
Change from baseline microvascular function at 24 weeks
Description
Measured as retinal vessel diameters.
Time Frame
Baseline and 24 weeks
Title
Change from baseline health-related quality of life (HRQOL) at 24 weeks
Description
Assessed with score in the 36-item Short Form questionnaire (SF-36).
Time Frame
Baseline and 24 weeks
Title
Change from baseline fatigue at 24 weeks
Description
Measured via the score in the 13-item FACIT Fatigue Scale.
Time Frame
Baseline and 24 weeks
Title
Perceived acceptance of intervention
Description
Measured via the Technology Acceptance Model (TAM) questionnaire.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arno Schmidt-Trucksäss, MD, MA, FESC
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel
City
Basel
State/Province
BS
ZIP/Postal Code
4052
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31128953
Citation
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.
Results Reference
derived
PubMed Identifier
30758293
Citation
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.
Results Reference
derived
PubMed Identifier
28264717
Citation
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.
Results Reference
derived

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Mobile Exergaming in Type 2 Diabetes

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