Type 2 Diabetes MellitusDE-PLAN-CATNCT01519505
Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia
A study testing Lifestyle intervention in people with Type 2 Diabetes Mellitus, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,082 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2005to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk (> or equal 14 points in FINDRISC score)
- PTOG with IFG/ITG or both
- Able to sign informed consent
Who cannot join
- Type 2 diabetes in screening
- Low risk (< 14 points in FINDRISC)
- Terminal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Lifestyle intervention
- Keywords
- Prevention, Diabetes mellitus, Lifestyle changes, Cardiovascular risk, Cost-effectiveness
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Also called Individual intervention, Group 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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Complete lifestyle counseling including
1. Individual intervention, OR
2. Group intervention Receives: Behavioral: Lifestyle intervention |
| Usual health care | No intervention | Usual health care, including self-administered information by leaflets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident cases of type 2 diabetes
New cases of type 2 diabetes in subjects with high risk during the duration of the study
Measured: 4 years
Secondary outcomes (2)
Evaluation of quality of life
Quality of life in the 15-D questionnaire
Measured: 4 years
Cost-effectiveness
Evaluation of cost-effectiveness of the efforts to prevent one case of diabetes
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startMar 2005
- Primary completionMar 2006
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,082 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Department of Health, Generalitat de Catalunya
- Responsible party
- Sponsor
- Investigators
- Bernardo Costa, MD PhD, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519505
- Sponsor's protocol ID
- P05/38
- Acronym
- DE-PLAN-CAT
- Status last verified
- Jan 2012
- First submitted
- 24 Jan 2012
- Last updated
- 27 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22322921
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia(DE-PLAN-CAT).
- ClinicalTrials.gov ID
- NCT01519505
- Acronym / sponsor ID
- DE-PLAN-CAT / P05/38
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Prevention, Diabetes mellitus, Lifestyle changes, Cardiovascular risk, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,082 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Department of Health, Generalitat de Catalunya
- Study start
- Mar 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2012 (estimated)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle interventionComplete lifestyle counseling including 1. Individual intervention, OR 2. Group intervention |
| Usual health care | No intervention | –Usual health care, including self-administered information by leaflets |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- High risk (> or equal 14 points in FINDRISC score)
- PTOG with IFG/ITG or both
- Able to sign informed consent
Key exclusion criteria (3 listed)
- Type 2 diabetes in screening
- Low risk (< 14 points in FINDRISC)
- Terminal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionAlso: Individual intervention, Group interventionINDIVIDUAL 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. | Behavioural | Lifestyle counseling |
Primary outcome
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
2 secondary outcomes
Evaluation of quality of life
Time frame: 4 years
Cost-effectiveness
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2012.
- Derived from this study: PubMed 22322921Costa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernardo Costa, MD PhD principal investigator
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Type 2 Diabetes Mellitus, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident cases of type 2 diabetes (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01519505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2012.