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Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients

NCT ID: NCT01735643

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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

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Type 2 Diabetes Mellitus

Keywords

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type 2 diabetes mellitus physical activity lifestyle change motivation patient empowerment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interactive videogame intervention

Group Type EXPERIMENTAL

interactive videogame Wii Fit Plus

Intervention Type DEVICE

Use of the interactive videogame Wii Fit Plus für 12 weeks.

waiting group

Group Type EXPERIMENTAL

waiting

Intervention Type OTHER

waiting for 12 weeks

Interventions

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interactive videogame Wii Fit Plus

Use of the interactive videogame Wii Fit Plus für 12 weeks.

Intervention Type DEVICE

waiting

waiting for 12 weeks

Intervention Type OTHER

Other Intervention Names

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Wii Fit Plus

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Nintendo of Europe GmbH

UNKNOWN

Sponsor Role collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Stephan Martin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephan Martin, MD

Role: PRINCIPAL_INVESTIGATOR

West German Center of Diabetes and Health

Locations

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West German Center of Diabetes and Health

Düsseldorf, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24321337 (View on PubMed)

Related Links

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http://www.vkkd-kliniken.de

Affiliation homepage

Other Identifiers

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Wii study

Identifier Type: -

Identifier Source: org_study_id