NCT03482674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
530

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

2.2 years

First QC Date

March 6, 2018

Last Update Submit

April 4, 2018

Conditions

Health BehaviorHealth Knowledge, Attitudes, PracticeLiteracyDiabetes Mellitus, Type 2Diabetes

Keywords

Health literacyInnovation Fundlifestyle interventionrisk screeningtype 2 diabetes mellitusDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Body weight reduction

    Survey of weight general practitioners level

    15 Months

Secondary Outcomes (4)

  • Health literacy (European Health Literacy Survey Questionnaire)

    15 Months

  • Eating behaviour (German questionnaire on eating behaviour)

    15 Months

  • Physical activity (International Physical Activity Questionnaire)

    15 Months

  • Quality of life

    15 Months

Study Arms (2)

Control Group

NO INTERVENTION

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

Intervention group

EXPERIMENTAL

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

Behavioral: DIMINI lifestyle intervention

Interventions

DIMINI lifestyle interventionBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

docevent GmbH

Schleswig, Schleswig-Holstein, 24837, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34008163DERIVED

MeSH Terms

Conditions

Health BehaviorBehaviorLiteracyDiabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

CommunicationGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Carsten Petersen, Dr.

    docevent GmbH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carsten Petersen, Dr.

CONTACT

+494621-855 425c.petersen@internisten-schleswig.de

Volker E Amelung, Prof. Dr.

CONTACT

+4930-24631222info@inav-berlin.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 29, 2018

Study Start

January 2, 2018

Primary Completion

March 31, 2020

Study Completion

July 1, 2020

Last Updated

April 6, 2018

Record last verified: 2018-04

Locations

DE(1)