DIMINI - Diabetes Mellitus? - Not me! (Dimini)

Dimini Konsortium

Status: Unknown

Conditions: Diabetes; Literacy; Health Behavior; Diabetes Mellitus, Type 2; Health Knowledge, Attitudes, Practice

Treatments: Behavioral: DIMINI lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03482674

01NVF17012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 530 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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530 participants in 2 patient groups

Control Group

No Intervention group

Description:

The control group will receive standard care as provided by the German statutory health insurance.

Intervention group

Experimental group

Description:

The intervention group receives the DIMINI lifestyle intervention for a period of three months.

Treatment:

Behavioral: DIMINI lifestyle intervention