NCT01519505

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,082

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 27, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

January 24, 2012

Last Update Submit

January 26, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

PreventionDiabetes mellitusLifestyle changesCardiovascular riskCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • Incident cases of type 2 diabetes

    New cases of type 2 diabetes in subjects with high risk during the duration of the study

    4 years

Secondary Outcomes (2)

  • Evaluation of quality of life

    4 years

  • Cost-effectiveness

    4 years

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Complete lifestyle counseling including 1. Individual intervention, OR 2. Group intervention

Behavioral: Lifestyle intervention

Usual health care

NO INTERVENTION

Usual health care, including self-administered information by leaflets

Interventions

Lifestyle interventionBEHAVIORAL

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.

Also known as: Individual intervention, Group intervention
Lifestyle counseling

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High risk (\> or equal 14 points in FINDRISC score)
  • PTOG with IFG/ITG or both
  • Able to sign informed consent

You may not qualify if:

  • Type 2 diabetes in screening
  • Low risk (\< 14 points in FINDRISC)
  • Terminal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Barcelona, Spain

Location

Related Publications (1)

  • Costa B, Barrio F, Cabre JJ, Pinol JL, Cos X, Sole C, Bolibar B, Basora J, Castell C, Sola-Morales O, Salas-Salvado J, Lindstrom 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.

    PMID: 22322921DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bernardo Costa, MD PhD

    Catalan Institute of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 27, 2012

Study Start

March 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2012

Last Updated

January 27, 2012

Record last verified: 2012-01

Locations

ES(1)