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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482674
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
Deutsche Diabetes Gesellschaft
Information provided by (Responsible Party):
Dimini Konsortium

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.

Condition or disease Intervention/treatment Phase
Health Behavior Health Knowledge, Attitudes, Practice Literacy Diabetes Mellitus, Type 2 Diabetes Behavioral: DIMINI lifestyle intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: DIMINI - Activating of Health Literacy in Persons With an Increased Risk of Type 2 Diabetes Mellitus by Coaching at General Practitioners
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

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.
Behavioral: DIMINI lifestyle intervention
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.




Primary Outcome Measures :
  1. Body weight reduction [ Time Frame: 15 Months ]
    Survey of weight general practitioners level


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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.

  4. Quality of life [ Time Frame: 15 Months ]
    Short Form 12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482674


Contacts
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Contact: Carsten Petersen, Dr. +494621-855 425 c.petersen@internisten-schleswig.de
Contact: Volker E Amelung, Prof. Dr. +4930-24631222 info@inav-berlin.de

Locations
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Germany
docevent GmbH Recruiting
Schleswig, Schleswig-Holstein, Germany, 24837
Contact: Carsten Petersen, Dr.    +494621-855 425    c.petersen@internisten-schleswig.de   
Sponsors and Collaborators
Dimini Konsortium
Deutsche Diabetes Gesellschaft
Investigators
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Principal Investigator: Carsten Petersen, Dr. docevent GmbH

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Responsible Party: Dimini Konsortium
ClinicalTrials.gov Identifier: NCT03482674    
Other Study ID Numbers: 01NVF17012
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dimini Konsortium:
Health literacy
Innovation Fund
lifestyle intervention
risk screening
type 2 diabetes mellitus
Diabetes Mellitus, Type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases