Type 2 Diabetes MellitusEarly Phase 1NCT01735643
Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients
A Early Phase 1 study testing interactive videogame Wii Fit Plus and waiting in people with Type 2 Diabetes Mellitus, run by West German Center of Diabetes and Health at 1 site in Germany.
Trial summary
Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes mellitus is increasing. Although in early phases the disease might be successfully treated by lifestyle change patients lack for motivation. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- interactive videogame Wii Fit Plus and waiting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Sep 2012
- Phase
- Early Phase 1
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- diabetes duration < 5 years
- age 50-75 years
- body mass index > or equal to 27 kg/m2
- participating in the disease management programme type 2 diabetes mellitus
- physical and mental able for study participation
Who cannot join
- insulin or antidiabetic medication (exception: Metformin and DPP-IV-Inhibitors)
- regular physical activity
- depression
- tumors
- change of smoking status during the past 6 months or during the study
- participation in other studies during the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spielend zu Mehr Bewegung - Lebensstilintervention Durch Das Interaktive Video-spiel "Wii Fit Plus" Bei Personen Mit Typ-2-Diabetes Mellitus
Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes mellitus is increasing. Although in early phases the disease might be successfully treated by lifestyle change patients lack for motivation. Instead of increasing anti-diabetic medication a highly motivational system with low inhibition threshold is needed. Therefore, the investigators analyzed if regular use of the interactive videogame Wii Fit Plus over 12 weeks is able to improve HbA1c and weight in patients with type 2 diabetes.
Read the detailed description
Patients with type 2 diabetes were recruited via treating physicians or articles in magazines and newspapers. Participants were randomized in an intervention and a control group. The intervention group was sent the Wii, the balance board and the interactive video game Wii Fit Plus and were instructed to use these items 30 minutes each day during the next 12 weeks. The control group got the items 12 weeks later. At begin and after 12 weeks of intervention participants (and additionally for the control group: after 12 weeks of waiting phase) sent their health parameters, which had been measured in the context of the disease management program type 2 diabetes as well as questionnaires about physical activity and quality of life to the study center.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- interactive videogame Wii Fit Plus, waiting
- Keywords
- type 2 diabetes mellitus, physical activity, lifestyle change, motivation, patient empowerment
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive videogame Wii Fit PlusDevice
Also called Wii Fit Plus
Use of the interactive videogame Wii Fit Plus für 12 weeks.
waitingOther
waiting for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| interactive videogame intervention | Experimental | Not described Receives: Device: interactive videogame Wii Fit Plus |
| waiting group | Experimental | Not described Receives: Other: waiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 12 weeks
Secondary outcomes (1)
weight
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Nintendo of Europe GmbH
- Responsible party
- Principal investigator, Stephan Martin, West German Center of Diabetes and Health
- Investigators
- Stephan Martin, MD, Principal investigator, West German Center of Diabetes and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735643
- Sponsor's protocol ID
- Wii study
- Status last verified
- Nov 2012
- First submitted
- 22 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kempf K, Martin S. Autonomous exercise game use improves metabolic control and quality of life in type 2 diabetes patients - a randomized controlled trial. BMC Endocr Disord. 2013 Dec 10;13:57. doi: 10.1186/1472-6823-13-57.
PubMed 24321337
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spielend zu Mehr Bewegung - Lebensstilintervention Durch Das Interaktive Video-spiel "Wii Fit Plus" Bei Personen Mit Typ-2-Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01735643
- Acronym / sponsor ID
- Wii study
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, physical activity, lifestyle change, motivation, patient empowerment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Nintendo of Europe GmbH
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Nov 2012 (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.
Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes mellitus is increasing. Although in early phases the disease might be successfully treated by lifestyle change patients lack for motivation. Instead of increasing anti-diabetic medication a highly motivational system with low inhibition threshold is needed. Therefore, the investigators analyzed if regular use of the interactive videogame Wii Fit Plus over 12 weeks is able to improve HbA1c and weight in patients with type 2 diabetes.
Detailed description
Patients with type 2 diabetes were recruited via treating physicians or articles in magazines and newspapers. Participants were randomized in an intervention and a control group. The intervention group was sent the Wii, the balance board and the interactive video game Wii Fit Plus and were instructed to use these items 30 minutes each day during the next 12 weeks. The control group got the items 12 weeks later. At begin and after 12 weeks of intervention participants (and additionally for the control group: after 12 weeks of waiting phase) sent their health parameters, which had been measured in the context of the disease management program type 2 diabetes as well as questionnaires about physical activity and quality of life to the study center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interactive videogame intervention | Experimental | Device: interactive videogame Wii Fit Plus |
| waiting group | Experimental | Other: waiting |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- type 2 diabetes mellitus
- diabetes duration < 5 years
- age 50-75 years
- body mass index > or equal to 27 kg/m2
- participating in the disease management programme type 2 diabetes mellitus
Key exclusion criteria (6 listed)
- insulin or antidiabetic medication (exception: Metformin and DPP-IV-Inhibitors)
- regular physical activity
- depression
- tumors
- change of smoking status during the past 6 months or during the study
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 |
|---|---|---|
| interactive videogame Wii Fit PlusAlso: Wii Fit PlusUse of the interactive videogame Wii Fit Plus für 12 weeks. | Device | interactive videogame intervention |
| waitingwaiting for 12 weeks | Other | waiting group |
Primary outcome
HbA1c
Time frame: 12 weeks
1 secondary outcome
weight
Time frame: 12 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 28 Nov 2012.
- Derived from this study: PubMed 24321337Kempf K, Martin S. Autonomous exercise game use improves metabolic control and quality of life in type 2 diabetes patients - a randomized controlled trial. BMC Endocr Disord. 2013 Dec 10;13:57. doi: 10.1186/1472-6823-13-57.
- Affiliation homepageLink provided by the sponsor.
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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.
Stephan Martin, MD principal investigator
West German Center of Diabetes and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing interactive videogame Wii Fit Plus and waiting in people with Type 2 Diabetes Mellitus, run by West German Center of Diabetes and Health at 1 site in Germany.
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 6 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 28 Nov 2012. 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 Germany. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HbA1c (time frame: 12 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 NCT01735643, which also lists 1 linked publication.
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 28 Nov 2012.