Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia (DE-PLAN-CAT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Jordi Gol i Gurina Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Departament de Salut de la Generalitat de Catalunya
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01519505
First received: January 24, 2012
Last updated: January 26, 2012
Last verified: January 2012

January 24, 2012
January 26, 2012
March 2005
March 2006   (final data collection date for primary outcome measure)
Incident cases of type 2 diabetes [ Time Frame: 4 years ] [ Designated as safety issue: No ]
New cases of type 2 diabetes in subjects with high risk during the duration of the study
Same as current
Complete list of historical versions of study NCT01519505 on ClinicalTrials.gov Archive Site
  • Evaluation of quality of life [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Quality of life in the 15-D questionnaire
  • Cost-effectiveness [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Evaluation of cost-effectiveness of the efforts to prevent one case of diabetes
Same as current
Not Provided
Not Provided
 
Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia
Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia(DE-PLAN-CAT).

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Type 2 Diabetes Mellitus
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.
Other Names:
  • Individual intervention
  • Group intervention
  • Experimental: Lifestyle counseling

    Complete lifestyle counseling including

    1. Individual intervention, OR
    2. Group intervention
    Intervention: Behavioral: Lifestyle intervention
  • No Intervention: Usual health care
    Usual health care, including self-administered information by leaflets
Costa B, Barrio F, Cabré JJ, Piñol JL, Cos X, Solé C, Bolíbar B, Basora J, Castell C, Solà-Morales O, Salas-Salvadó J, Lindström J, Tuomilehto J; DE-PLAN-CAT Research Group. Delaying progression to type 2 diabetes among high-risk Spanish individuals is feasible in real-life primary healthcare settings using intensive lifestyle intervention. Diabetologia. 2012 May;55(5):1319-28. doi: 10.1007/s00125-012-2492-6. Epub 2012 Feb 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2082
March 2012
March 2006   (final data collection date for primary outcome measure)

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
Both
45 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01519505
P05/38
No
Jordi Gol i Gurina Foundation
Jordi Gol i Gurina Foundation
  • Instituto de Salud Carlos III
  • Departament de Salut de la Generalitat de Catalunya
Principal Investigator: Bernardo Costa, MD PhD Catalan Health Institute
Jordi Gol i Gurina Foundation
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP