Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia (DE-PLAN-CAT)
|ClinicalTrials.gov Identifier: NCT01519505|
Recruitment Status : Unknown
Verified January 2012 by Jordi Gol i Gurina Foundation.
Recruitment status was: Active, not recruiting
First Posted : January 27, 2012
Last Update Posted : January 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Behavioral: Lifestyle intervention||Not Applicable|
Diabetes is one of the most devastating diseases because of its big impact on public health. Taking fast decisions and vigorous actions like the ones proposed by this European project (DE-PLAN) adapted to the Spanish and the Catalan actual situation (coordinated project FIS and DE-PLAN-CAT respectively) can avert it.
We consider a two-step strategy whose main objective is the primary prevention of diabetes in the European population at highest-risk. At the first stage, a non-invasive screening program will evaluate the risk of diabetes by means of a validated questionnaire (FINDRISK survey). It will be distributed at random to 2000 outpatients of public health service in Catalonia. It involves twenty primary care facilities that refer to five different centers where research scientists (executive committee) are coordinated by the head of these centers (coordinating committee) and are organised (managing committee) according to the European regulation (central committee). One third of the subjects are expected to present high-risk criteria. They will choose one out of three possible interventions to modify their lifestyle (informative approach, one-to-one or group training). For the last options, a 6-hour training program will be carried out in four sessions lasting 1,5 hours each. The trainers in charge will periodically stimulate the participants motivation.
The study will go on in the routine health care and it will assess diabetes incidence according to the economic estimation of the cost-effectiveness relation of the adopted measures involved in health care policies and prevention programs.
This project aims to evidence how the already known efficacy of these types of programs can apply to its effectiveness (on large populations) and its cost-effectiveness (in socio-economic terms). Other objectives are 1) to create one bigger database of diabetes and cardiovascular disease risks and 2) to contribute to the edition of a European manual on type 2 diabetes prevention.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2082 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia(DE-PLAN-CAT).|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||March 2006|
|Estimated Study Completion Date :||March 2012|
Experimental: Lifestyle counseling
Complete lifestyle counseling including
Behavioral: Lifestyle intervention
INDIVIDUAL INTERVENTIONS They were programmed to come the nurse office three times (1 ½ -2 hours each). Individual intervention efforts outside of weight control and other intervention groups were also supported. In fact, this kind of intervention was similar to the group intervention but one-by-one participant subject. GROUP INTERVENTIONS Six-hour educational programme structured in 2 to 4 sessions with 5 to 15 participants. We called all participants to remind them their group schedule (date/hour). The methods used in the group intervention were variable depending on the experience of the manager, group member' s needs and skills available (empowerment). Results were based on motivation, support from the other members, peer support and positive feedback.
No Intervention: Usual health care
Usual health care, including self-administered information by leaflets
- Incident cases of type 2 diabetes [ Time Frame: 4 years ]New cases of type 2 diabetes in subjects with high risk during the duration of the study
- Evaluation of quality of life [ Time Frame: 4 years ]Quality of life in the 15-D questionnaire
- Cost-effectiveness [ Time Frame: 4 years ]Evaluation of cost-effectiveness of the efforts to prevent one case of diabetes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519505
|IDIAP Jordi Gol|
|Principal Investigator:||Bernardo Costa, MD PhD||Catalan Institute of Health|