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

April 4, 2018 updated by: Dimini Konsortium

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

530

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group will receive standard care as provided by the German statutory health insurance.
Experimental: Intervention group
The intervention group receives the DIMINI lifestyle intervention for a period of three months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight reduction
Time Frame: 15 Months
Survey of weight general practitioners level
15 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health literacy (European Health Literacy Survey Questionnaire)
Time Frame: 15 Months

Summed scale:

  • Maximum: 16 (best health literacy)
  • Minimum: 0 (worst health literacy)
  • ≥ 13 = sufficient health literacy
  • 9-12 = problematic health literacy
  • ≤ 8 = inadequate health literacy Higher values represent a better outcome
15 Months
Eating behaviour (German questionnaire on eating behaviour)
Time Frame: 15 Months

Three summed subscales:

Scale 1) cognitive control of eating behavior, restrained eating

  • Minimum score: 0 = no cognitive control
  • Maximum score: 21 = extreme cognitive control Scale 2) disturbance of eating behavior
  • Minimum score: 0 = no disturbance
  • Maximum score: 16 = extreme disturbance Scale 3) experienced feelings of hunger
  • Minimum score: 0 = no disturbing sensations of hunger
  • Maximum score: 14 = very strong disturbing sensations of hunger For each item it is determined individually, which response option is considered to get a value of 1 or a value of 0 (e.g. Scale 1 Item 12: "true" = 1, "not true" = 0, Item 18 "true" = 0, "not true" = 1)
15 Months
Physical activity (International Physical Activity Questionnaire)
Time Frame: 15 Months

Questionnaire designed for population surveillance of physical activity among adults including

Total Score:

  • Maximum Score: 960 minutes
  • Minimum Score: 10 minutes

Categorical Score:

Category 1 - Low:

• Individuals who not meet criteria for Categories 2 or 3

Category 2 - Moderate:

  • 3 or more days of vigorous-intensity activity of at least 20 minutes per day
  • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day
  • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum total physical activity of at least 600 minutes/week.

Category 3 High

  • vigorous-intensity activity on at least 3 days achieving a minimum total physical activity of at least 1500 minutes/week
  • 7 or more days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum total physical activity of at least 3000 minutes/week.
15 Months
Quality of life
Time Frame: 15 Months
Short Form 12
15 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carsten Petersen, Dr., docevent GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2018

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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