Study Results
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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UNKNOWN
NA
530 participants
INTERVENTIONAL
2018-01-02
2020-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control Group
The control group will receive standard care as provided by the German statutory health insurance.
No interventions assigned to this group
Intervention group
The intervention group receives the DIMINI lifestyle intervention for a period of three months.
DIMINI lifestyle intervention
DIMINI lifestyle intervention consists of the DIMINI-kit which contains health information, a list of food recommendations with additional information on calories, serving size and weight (traffic light rating system), a nutrition and an exercise diary. Participants in the intervention group can choose between a paper-based version or an app-based version of the DIMINI-kit. In addition, the kit includes an elastic exercise band with exercise poster, a measuring tape for self-control of the waist size and a pedometer.
Interventions
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DIMINI lifestyle intervention
DIMINI lifestyle intervention consists of the DIMINI-kit which contains health information, a list of food recommendations with additional information on calories, serving size and weight (traffic light rating system), a nutrition and an exercise diary. Participants in the intervention group can choose between a paper-based version or an app-based version of the DIMINI-kit. In addition, the kit includes an elastic exercise band with exercise poster, a measuring tape for self-control of the waist size and a pedometer.
Eligibility Criteria
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Inclusion Criteria
* resident in Hesse or Schleswig-Holstein
* statutory health insurance in one out of five participating health insurances
* overweight/obesity
* low physical activity
* known family disposition for type 2 diabetes mellitus
* history of increased glucose levels
* FINDRISC results with scores ≥ 12
Exclusion Criteria
* resident outside Hesse or Schleswig-Holstein
* statutory or private health insurance with other than the participating health insurances
* clinically manifested diabetes mellitus
* malnutrition
* psychiatric disorders
* pregnancy
* FINDRISC results with scores \<12
* participation in other clinical trials
18 Years
ALL
Yes
Sponsors
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Deutsche Diabetes Gesellschaft
OTHER
Dimini Konsortium
OTHER
Responsible Party
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Principal Investigators
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Carsten Petersen, Dr.
Role: PRINCIPAL_INVESTIGATOR
docevent GmbH
Locations
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docevent GmbH
Schleswig, Schleswig-Holstein, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Puschner F, Wetzel S, Urbanski-Rini D, Bertram N, Schliffke M, Gohl M, Petersen C; Dimini Consortium. The association between the risk of developing type 2 diabetes mellitus and health-related quality of life: baseline results from the Dimini lifestyle intervention. Qual Life Res. 2021 Dec;30(12):3523-3533. doi: 10.1007/s11136-021-02878-2. Epub 2021 May 19.
Other Identifiers
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01NVF17012
Identifier Type: -
Identifier Source: org_study_id
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