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

Primary Purpose

Health Behavior, Health Knowledge, Attitudes, Practice, Literacy

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
DIMINI lifestyle intervention
Sponsored by
Dimini Konsortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Behavior focused on measuring Health literacy, Innovation Fund, lifestyle intervention, risk screening, type 2 diabetes mellitus, Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • docevent GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Body weight reduction
Survey of weight general practitioners level

Secondary Outcome Measures

Health literacy (European Health Literacy Survey Questionnaire)
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
Eating behaviour (German questionnaire on eating behaviour)
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)
Physical activity (International Physical Activity Questionnaire)
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.
Quality of life
Short Form 12

Full Information

First Posted
March 6, 2018
Last Updated
April 4, 2018
Sponsor
Dimini Konsortium
Collaborators
Deutsche Diabetes Gesellschaft
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1. Study Identification

Unique Protocol Identification Number
NCT03482674
Brief Title
DIMINI - Diabetes Mellitus? - Not me!
Acronym
Dimini
Official Title
DIMINI - Activating of Health Literacy in Persons With an Increased Risk of Type 2 Diabetes Mellitus by Coaching at General Practitioners
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dimini Konsortium
Collaborators
Deutsche Diabetes Gesellschaft

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior, Health Knowledge, Attitudes, Practice, Literacy, Diabetes Mellitus, Type 2, Diabetes
Keywords
Health literacy, Innovation Fund, lifestyle intervention, risk screening, type 2 diabetes mellitus, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive standard care as provided by the German statutory health insurance.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group receives the DIMINI lifestyle intervention for a period of three months.
Intervention Type
Behavioral
Intervention Name(s)
DIMINI lifestyle intervention
Intervention Description
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 Measure Information:
Title
Body weight reduction
Description
Survey of weight general practitioners level
Time Frame
15 Months
Secondary Outcome Measure Information:
Title
Health literacy (European Health Literacy Survey Questionnaire)
Description
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
Time Frame
15 Months
Title
Eating behaviour (German questionnaire on eating behaviour)
Description
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)
Time Frame
15 Months
Title
Physical activity (International Physical Activity Questionnaire)
Description
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.
Time Frame
15 Months
Title
Quality of life
Description
Short Form 12
Time Frame
15 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carsten Petersen, Dr.
Phone
+494621-855 425
Email
c.petersen@internisten-schleswig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Volker E Amelung, Prof. Dr.
Phone
+4930-24631222
Email
info@inav-berlin.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carsten Petersen, Dr.
Organizational Affiliation
docevent GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
docevent GmbH
City
Schleswig
State/Province
Schleswig-Holstein
ZIP/Postal Code
24837
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten Petersen, Dr.
Phone
+494621-855 425
Email
c.petersen@internisten-schleswig.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
34008163
Citation
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.
Results Reference
derived

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DIMINI - Diabetes Mellitus? - Not me!

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