Trial record 1 of 1 for:
NCT01735643
Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients
This study has been completed.
Sponsor:
West German Center of Diabetes and Health
Collaborators:
Novartis Pharmaceuticals
Nintendo of Europe GmbH
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier:
NCT01735643
First received: November 22, 2012
Last updated: November 27, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Device: interactive videogame Wii Fit Plus Other: waiting |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Spielend zu Mehr Bewegung - Lebensstilintervention Durch Das Interaktive Video-spiel "Wii Fit Plus" Bei Personen Mit Typ-2-Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by West German Center of Diabetes and Health:
Primary Outcome Measures:
- HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 220 |
| Study Start Date: | January 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: interactive videogame intervention |
Device: interactive videogame Wii Fit Plus
Use of the interactive videogame Wii Fit Plus für 12 weeks.
Other Name: Wii Fit Plus
|
| Experimental: waiting group |
Other: waiting
waiting for 12 weeks
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01735643
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735643
Locations
| Germany | |
| West German Center of Diabetes and Health | |
| Düsseldorf, Germany, 40591 | |
Sponsors and Collaborators
West German Center of Diabetes and Health
Novartis Pharmaceuticals
Nintendo of Europe GmbH
Investigators
| Principal Investigator: | Stephan Martin, MD | West German Center of Diabetes and Health |
More Information
Additional Information:
| Responsible Party: | Stephan Martin, MD, West German Center of Diabetes and Health |
| ClinicalTrials.gov Identifier: | NCT01735643 History of Changes |
| Other Study ID Numbers: | Wii study |
| Study First Received: | November 22, 2012 |
| Last Updated: | November 27, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by West German Center of Diabetes and Health:
|
type 2 diabetes mellitus physical activity lifestyle change motivation patient empowerment |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 28, 2016