An interventional study of DIMINI lifestyle intervention in Health Behavior, Health Knowledge, Attitudes, Practice and Literacy, sponsored by Dimini Konsortium. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by Dimini Konsortium · Not applicable, Interventional, and Prevention
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.
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.
967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.
This study's planned enrollment of 530 is above the median of 150 across 824 interventional studies indexed under Health Behavior.
Browse Health Behavior studies →This is the only study on the registry with Dimini Konsortium as lead sponsor.
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Exclusion Criteria:
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.
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.
Body weight reduction
Survey of weight general practitioners level
Time frame: 15 Months
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
Time frame: 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)
Time frame: 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.
Time frame: 15 Months
Quality of life
Short Form 12
Time frame: 15 Months
Started Jan 2018 (actual). Primary completion is estimated for Mar 2020, 26 months after the start.
Of 567 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 26 months is above that.
Counting every sponsor, half of 585 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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