DIMINI - Diabetes Mellitus? - Not me!

Diabetes Mellitus, Type 2 Clinical Trial

— Dimini  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03482674
• Other study ID #: 01NVF17012
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2018
• Last updated: April 4, 2018
• Start date: January 2, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: April 2018
• Source: Dimini Konsortium
• Contact: Carsten Petersen, Dr.
• Phone: +494621-855 425
• Email: c.petersen[@]internisten-schleswig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: July 1, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Health Behavior
• Health Knowledge, Attitudes, Practice
• Literacy

Intervention

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.

Locations

Country	Name	City	State
Germany	docevent GmbH	Schleswig	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Dimini Konsortium	Deutsche Diabetes Gesellschaft

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight reduction	Survey of weight general practitioners level	15 Months
Secondary	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	15 Months
Secondary	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)	15 Months
Secondary	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.	15 Months
Secondary	Quality of life	Short Form 12	15 Months