Health BehaviorDiminiNCT03482674
DIMINI - Diabetes Mellitus? - Not me!
A study testing DIMINI lifestyle intervention in people with Health Behavior and Health Knowledge, Attitudes, Practice, run by Dimini Konsortium at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Health Knowledge, Attitudes, Practice, Literacy
- What is being tested?
- DIMINI lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- pregnancy
- FINDRISC results with scores <12
- participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
docevent GmbH
Schleswig, Schleswig-Holstein, 24837
Carsten Petersen, Dr., +494621-855 425, c.petersen@internisten-schleswig.de
About this study
Official title: DIMINI - Activating of Health Literacy in Persons With an Increased Risk of Type 2 Diabetes Mellitus by Coaching at General Practitioners
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.
Read the 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.
- Conditions
- Health Behavior, Health Knowledge, Attitudes, Practice, Literacy, Diabetes Mellitus, Type 2, Diabetes
- Being tested
- DIMINI lifestyle intervention
- Keywords
- Health literacy, Innovation Fund, lifestyle intervention, risk screening, type 2 diabetes mellitus, Diabetes Mellitus, Type 2
- Medical subject headings
- Health Behavior, Behavior, Literacy, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIMINI lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will receive standard care as provided by the German statutory health insurance. |
| Intervention group | Experimental | The intervention group receives the DIMINI lifestyle intervention for a period of three months. Receives: Behavioral: DIMINI lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight reduction
Survey of weight general practitioners level
Measured: 15 Months
Secondary outcomes (4)
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
Measured: 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)
Measured: 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.
Measured: 15 Months
Quality of life
Short Form 12
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start2 Jan 2018
- Primary completion31 Mar 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dimini Konsortium
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Diabetes Gesellschaft
- Responsible party
- Sponsor
- Investigators
- Carsten Petersen, Dr., Principal investigator, docevent GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482674
- Sponsor's protocol ID
- 01NVF17012
- Acronym
- Dimini
- Status last verified
- Apr 2018
- First submitted
- 6 Mar 2018
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34008163
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIMINI - Activating of Health Literacy in Persons With an Increased Risk of Type 2 Diabetes Mellitus by Coaching at General Practitioners
- ClinicalTrials.gov ID
- NCT03482674
- Acronym / sponsor ID
- Dimini / 01NVF17012
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Dimini KonsortiumUniversity, hospital or other
- Collaborators
- Deutsche Diabetes Gesellschaft
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive standard care as provided by the German statutory health insurance. |
| Intervention group | Experimental | Behavioral: DIMINI lifestyle interventionThe intervention group receives the DIMINI lifestyle intervention for a period of three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIMINI lifestyle interventionDIMINI 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. | Behavioural | Intervention group |
Primary outcome
Body weight reduction
Time frame: 15 Months
Survey of weight general practitioners level
4 secondary outcomes
Health literacy (European Health Literacy Survey Questionnaire)
Time frame: 15 Months
Eating behaviour (German questionnaire on eating behaviour)
Time frame: 15 Months
Physical activity (International Physical Activity Questionnaire)
Time frame: 15 Months
Quality of life
Time frame: 15 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Derived from this study: PubMed 34008163Puschner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Petersen, Dr. principal investigator
docevent GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIMINI lifestyle intervention in people with Health Behavior and Health Knowledge, Attitudes, Practice, run by Dimini Konsortium at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carsten Petersen, Dr. (+494621-855 425, c.petersen@internisten-schleswig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight reduction (time frame: 15 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03482674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.