- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03482674
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Carsten Petersen, Dr.
- Phone Number: +494621-855 425
- Email: c.petersen@internisten-schleswig.de
Study Contact Backup
- Name: Volker E Amelung, Prof. Dr.
- Phone Number: +4930-24631222
- Email: info@inav-berlin.de
Study Locations
-
-
Schleswig-Holstein
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Schleswig, Schleswig-Holstein, Germany, 24837
- Recruiting
- docevent GmbH
-
Contact:
- Carsten Petersen, Dr.
- Phone Number: +494621-855 425
- Email: c.petersen@internisten-schleswig.de
-
-
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:
|
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
|
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:
Categorical Score: Category 1 - Low: • Individuals who not meet criteria for Categories 2 or 3 Category 2 - Moderate:
Category 3 High
|
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.
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01NVF17012
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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