OverweightMOBIGAMENCT02657018
Mobile Exergaming in Type 2 Diabetes
A study testing MOBIGAME in people with Overweight and Obesity, run by University of Basel at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Overweight, Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- MOBIGAME
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel
Basel, Canton of Basel-City, 4052
About this study
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)
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.
Read the 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.
- Conditions
- Overweight, Obesity, Diabetes Mellitus, Type 2
- Being tested
- MOBIGAME, Control
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBIGAMEDevice
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | MOBIGAME group Receives: Device: MOBIGAME |
| Control | Active comparator | Lifestyle counseling group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline daily physical activity at 24 weeks
Measured as steps per day.
Measured: Baseline and 24 weeks
Secondary outcomes (1)
Adherence to the intervention
Measured as usage log entries (intervention group) and self-reported exercise log entries (control group).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Arno Schmidt-Trucksäss, University of Basel
- Investigators
- Arno Schmidt-Trucksäss, MD, MA, FESC, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657018
- Sponsor's protocol ID
- EKNZ 2015-424
- Acronym
- MOBIGAME
- Status last verified
- Apr 2018
- First submitted
- 11 Jan 2016
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31128953Hochsmann 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.
PubMed 30758293Hochsmann 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.
PubMed 28264717
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02657018
- Acronym / sponsor ID
- MOBIGAME / EKNZ 2015-424
- Conditions
- Overweight, Obesity, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Aug 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: MOBIGAMEMOBIGAME group |
| Control | Active comparator | Other: ControlLifestyle counseling group |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOBIGAMEMobile 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. | Device | Intervention |
| ControlOne-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. | Other | Control |
Primary outcome
Change from baseline daily physical activity at 24 weeks
Time frame: Baseline and 24 weeks
Measured as steps per day.
1 secondary outcome
Adherence to the intervention
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Derived from this study: PubMed 31128953Hochsmann 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.
- Derived from this study: PubMed 30758293Hochsmann 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.
- Derived from this study: PubMed 28264717Hochsmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arno Schmidt-Trucksäss, MD, MA, FESC principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOBIGAME in people with Overweight and Obesity, run by University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline daily physical activity at 24 weeks (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657018, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.