DIMINI - Diabetes Mellitus? - Not me!

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: DIMINI lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>The control group will receive standard care as provided by the German statutory health insurance. | |
| Experimental: Intervention group<br>The intervention group receives the DIMINI lifestyle intervention for a period of three months. | Behavioral: DIMINI lifestyle intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight reduction | Survey of weight general practitioners level | 15 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Quality of life | Short Form 12 | 15 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health literacy, Innovation Fund, lifestyle intervention, risk screening, type 2 diabetes mellitus, Diabetes Mellitus, Type 2