This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment lifestyle intervention
Sponsor Jordi Gol i Gurina Foundation
Collaborator Instituto de Salud Carlos III
Start date March 2005
End date March 2006
Trial size 2082 participants
Trial identifier NCT01519505, P05/38


Public health strategy on type2 diabetes prevention in primary health care. European coordinated project (DE-PLAN) adapted to Catalonia (DE-PLAN-CAT). Two-step multicentre cohort study: cross-over period (screening) plus a follow-up period (preventive intervention): 12 centres, 7 working-groups, 42 units, 106 professionals). Interventions: Randomized non-invasive diabetes screening program by means of the FINDRISC score comparing with the oral glucose tolerance test results. At least one third of the screened subjects is expected to present high-risk criteria. They will choose 1 out of 3 interventions to modify lifestyle: self-acting vs. individualized or group-based educative (6-hour, 3 or 4 sessions program). Participants' motivation will be periodically reinforced. Follow-up will be focused on diabetes incidence, cardiovascular risk (HearthScore, Regicor scores), lifestyle-quality of life (assessed by European peer-reviewed questionnaires) and cost-effectiveness analysis. First-year results includes: protocol, measurement tools and database available, screening concluded (n=2082) and European intervention manual on type 2 diabetes prevention started.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Complete lifestyle counseling including Individual intervention, OR Group intervention
lifestyle intervention Individual 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, including self-administered information by leaflets

Primary Outcomes

Incident cases of type 2 diabetes
time frame: 4 years

Secondary Outcomes

Evaluation of quality of life
time frame: 4 years
time frame: 4 years

Eligibility Criteria

Male or female participants from 45 years up to 74 years old.

Inclusion Criteria: - High risk (> or equal 14 points in FINDRISC score) - PTOG with IFG/ITG or both - Able to sign informed consent Exclusion Criteria: - Type 2 diabetes in screening - Low risk (< 14 points in FINDRISC) - Terminal diseases

Additional Information

Official title Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia(DE-PLAN-CAT).
Principal investigator Bernardo Costa, MD PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Jordi Gol i Gurina Foundation.