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Clinical Trials/NCT03482674
NCT03482674
Unknown
Not Applicable

DIMINI - Activating of Health Literacy in Persons With an Increased Risk of Type 2 Diabetes Mellitus by Coaching at General Practitioners

Dimini Konsortium1 site in 1 country530 target enrollmentJanuary 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Behavior
Sponsor
Dimini Konsortium
Enrollment
530
Locations
1
Primary Endpoint
Body weight reduction
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2018
End Date
July 1, 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dimini Konsortium
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Body weight reduction

Time Frame: 15 Months

Survey of weight general practitioners level

Secondary Outcomes

  • Health literacy (European Health Literacy Survey Questionnaire)(15 Months)
  • Quality of life(15 Months)
  • Eating behaviour (German questionnaire on eating behaviour)(15 Months)
  • Physical activity (International Physical Activity Questionnaire)(15 Months)

Study Sites (1)

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