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
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Behavioral: Lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia(DE-PLAN-CAT).

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 2082
Study Start Date: March 2005
Estimated Study Completion Date: March 2012
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling

Complete lifestyle counseling including

  1. Individual intervention, OR
  2. Group intervention
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
No Intervention: Usual health care
Usual health care, including self-administered information by leaflets

Detailed 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.

  Eligibility

Ages Eligible for Study:   45 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519505

Locations
Spain
IDIAP Jordi Gol
Barcelona, Spain
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Instituto de Salud Carlos III
Departament de Salut de la Generalitat de Catalunya
Investigators
Principal Investigator: Bernardo Costa, MD PhD Catalan Health Institute
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01519505     History of Changes
Other Study ID Numbers: P05/38
Study First Received: January 24, 2012
Last Updated: January 26, 2012
Health Authority: Spain: Departament de Salut de la Generalitat de Catalunya
Spain: Comité Ético de Investigación Clínica

Keywords provided by Jordi Gol i Gurina Foundation:
Prevention
Diabetes mellitus
Lifestyle changes
Cardiovascular risk
Cost-effectiveness

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014