Clinical trial NCT03482674: DIMINI - Diabetes Mellitus? - Not me!
Official title: DIMINI - Activating of Health Literacy in Persons With an Increased Risk of Type 2 Diabetes Mellitus by Coaching at General Practitioners
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Health Knowledge, Attitudes, Practice
Literacy
Diabetes Mellitus, Type 2
Diabetes
Keywords: Health literacy
Innovation Fund
lifestyle intervention
risk screening
type 2 diabetes mellitus
Diabetes Mellitus, Type 2
Lead sponsor: Dimini Konsortium
Sponsor class: OTHER
Collaborators: name: Deutsche Diabetes Gesellschaft
First posted: 2018-03-29
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The increasing prevalence of type 2 diabetes mellitus is a worldwide problem. In preventing risk factors and unhealthy lifestyle through improved health literacy, chances are seen to delay or even avoid type 2 diabetes mellitus. The aim of the DIMINI-project is to prevent type 2 diabetes mellitus and to strengthen the health literacy of people at increased risk of developing it. For this purpose, people at increased risk are first identified by using the standardized screening tool Finnish Diabetes Risk Score (FINDRISC) adapted for Germany. Identified risk persons then receive a needs-based, modular lifestyle intervention including nutrition tips and physical exercises either paper- or app-based.

Detailed description: DIMINI, a randomised controlled trial, will assess whether the implementation of a lifestyle intervention for people at increased risk of developing type 2 diabetes mellitus will result in an improvement in body weight (primary outcome) and participants health literacy (secondary outcome) or not. A three-month intervention in the intervention group is followed by a one-year follow-up. The control group receives standard care as provided by the German statutory health insurance for three months and a one-year follow-up as well.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* 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:

* age \< 18 years
* 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

Primary outcomes:
measure: Body weight reduction
timeFrame: 15 Months
Secondary outcomes:
measure: Health literacy (European Health Literacy Survey Questionnaire)
timeFrame: 15 Months
measure: Eating behaviour (German questionnaire on eating behaviour)
timeFrame: 15 Months
measure: Physical activity (International Physical Activity Questionnaire)
timeFrame: 15 Months
measure: Quality of life
timeFrame: 15 Months
Other outcomes:
Locations:
city: Schleswig
country: Germany
facility: docevent GmbH
state: Schleswig-Holstein
Study officials:
affiliation: docevent GmbH
name: Carsten Petersen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.