No registrations found.
ID
Source
Brief title
Health condition
The program focusses on "pre-diabetic" individuals in the 40-70 year age group. Their diabetes risk is assessed with the help of an 8 item questionnaire, which includes a/o BMI, waist circumference, age, family history.
Sponsors and support
University of Tilburg / TRANZO
RIVM
CZ Zorgverzekeringen
VGZ Zorgverzekeringen
Intervention
Outcome measures
Primary outcome
Reduction of risk-score for type 2 diabetes;
reduction of incident type 2 diabetes.
Secondary outcome
Quality of life of participants;
success- and failure factors in the primary care environment which carries out the program.
Background summary
The 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.
Study objective
Prevention 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.
Study design
October 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.
Intervention
Life-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.
Inclusion criteria
Individuals 40-70 years with increased risk to develop type 2 diabetes.
Exclusion criteria
1. Unwilling to participate;
2. current diabetes;
3. serious (terminal) illness;
4. unable to participate mentally or physically;
5. pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1049 |
| NTR-old | NTR1082 |
| Other | TRANZO / University of Tilburg : FW |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |