DIMINI - Diabetes Mellitus? - Not me!

Not Applicable

• Conditions: Health Behavior; Diabetes Mellitus, Type 2; Literacy; Diabetes; Health Knowledge, Attitudes, Practice
• Interventions: Behavioral: DIMINI lifestyle intervention

• Registration Number: NCT03482674
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-01-02
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-28
• Study First Posted: 2018-03-29
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-06
• Primary Completion: 2020-03-31
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 530

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Body weight reduction	15 Months	Survey of weight general practitioners level

Secondary Outcome Measures

Name	Time	Method
Health literacy (European Health Literacy Survey Questionnaire)	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
Quality of life	15 Months	Short Form 12
Eating behaviour (German questionnaire on eating behaviour)	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)
Physical activity (International Physical Activity Questionnaire)	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.

Trial Locations

Locations (1)

docevent GmbH; 🇩🇪 Schleswig, Schleswig-Holstein, Germany