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Diabetes Prevention Eindhoven.


- candidate number2788
- NTR NumberNTR1082
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-okt-2007
- Secondary IDsFW TRANZO / University of Tilburg
- Public TitleDiabetes Prevention Eindhoven.
- Scientific TitleImplementation of a concept for active primary prevention of type 2 diabetes in high risk individuals in a primary care setting.
- ACRONYMAPHRODITE (Active Prevention in High Risk individuals Of DIabetes Type 2 in Eindhoven)
- hypothesisPrevention of type 2 diabetes (T2D) in high-risk individuals has been proven to be possible, as demonstated e.g. by the SLIM-, DPP- and DPS- studies. Intervention to achieve lifestyle adjustments appears to be effective in reducing the risk factors and the incidence of T2D. We will investigate the implementation of such a concept in the primary care field, using an active approach, i.e. individuals will be requested to assess their risk for T2D by their own family physician; if high risk, they will be suggested to participate in a lifestyle improvement program, which is aiming to achieve long-lasting effects. Education, motivation, providing tools and support, and monitoring are the main elements of the program. Motivational interviewing is the basic technique to have the participants obtain "ownership" of their situation and of the ways to make the necessary adjustments.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteriaIndividuals 40-70 years with increased risk to develop type 2 diabetes.
- Exclusion criteria1. Unwilling to participate;
2. current diabetes;
3. serious (terminal) illness;
4. unable to participate mentally or physically;
5. pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2007
- planned closingdate1-feb-2011
- Target number of participants1000
- InterventionsLife-style intervention to increase daily physical excercise, improve quality of diet/food intake, aiming at long-lasting and sustained effect. We strive to implement the changes in a gradual way in the normal daily life, avoiding complex and "artificial" measures such as calorie-counting, crash-diets and exaggerated physical excercise.
- Primary outcomeReduction of risk-score for type 2 diabetes; reduction of incident type 2 diabetes.
- Secondary outcomeQuality of life of participants;
success- and failure factors in the primary care environment which carries out the program.
- TimepointsOctober 2007: sending out 16,000 letters to patients aged 40-70 years of 45 primary care physicians.
November/ December2007: selecting high-risk individuals and peerforming the intake interviews to have them participate.
January 2008: start actual intervention.
- Trial web sitet.b.d.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESIr. Frits Wielaard
- CONTACT for SCIENTIFIC QUERIESDrs. Paulien Vermunt
- Sponsor/Initiator University of Tilburg/TRANZO
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, VGZ, CZ Actief in gezondheid
- PublicationsN/A
- Brief summaryThe study will explore the efficacy and efficiency of a lifestyle intervention program to reduce the risk / incidence of type 2 diabetes in high-risk individuals, acively selected by their own primary care physician.
Duration of the intervention is 2.5 years. The intervention is based on frequent interviews/discussions between the participant and his/her physician and the nurse-practitioner, on average 4 times per year. In addition, group sessions with a dietician will be held to educate the participants on food aspects and to provide the opportunity to exchange experiences, ask questions, etc. In total the study will comprize 500 participants in the intervention arm and 500 controls. We will study the various success- and failure factors in the primary care setting, and include the participants' experiences, quality-of-life aspects in the final analysis.
- Main changes (audit trail)
- RECORD10-okt-2007 - 26-aug-2008


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