Diabetes MellitusITADINCT00954967
Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project
A study testing Lifestyle Counseling in people with Diabetes Mellitus and Smoking Cessation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Diabetes Mellitus, Smoking Cessation
- What is being tested?
- Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to Sep 2011
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diabetic patients who are active smokers
- over the age of 14
- receive routine care in their respective health center
Who cannot join
- patients with communication difficulties (cognitive deterioration, language barrier)
- patients who normally receive their habitual care in a different health center
- patients with terminal diseases, psychiatric diseases that are unstable, or with addictions to other substances
- patients that are already receiving treatment to quit smoking at the time of recruitment
- patients that are difficult to locate during the study period
- patients that refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care
This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. This study aims to evaluate the effectiveness of an intensive intervention in tobacco addiction in diabetic patients in primary care.
Read the detailed description
Other objectives of the study are:
- To study the effectiveness of an intensive smoking cessation intervention in the evolution of the phases of change, as based on the Prochaska and DiClemente model, in diabetic patients attended in primary care.
- To evaluate the effectiveness of an intensive smoking cessation intervention in the evolution of tabacco consumption in diabetic patients attended in primary care.
- To quantify the time spent in the intensive smoking cessation intervention compared with the usual care in primary care.
- Conditions
- Diabetes Mellitus, Smoking Cessation
- Being tested
- Lifestyle Counseling
- Keywords
- Diabetes Mellitus, Smoking Cessation, Primary Health Care, Motivational Interview
- Medical subject headings
- Diabetes Mellitus, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CounselingBehavioural
The intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | The subjects in the control group will receive the usual care for smoking cessation in diabetic smokers. |
| Lifestyle Counseling | Experimental | The intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques. Receives: Behavioral: Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less
Measured: 12 months after initiation of study
Secondary outcomes (3)
Evolution of the phases of change of the Prochaska and DiClemente model
Measured: 12 months after initiation of the study
Number of cigarettes per day
Measured: 12 months after initiation of the study
Total time (minutes) spent in the intensive smoking cessation intervention
Measured: 12 months after initiation of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionSep 2011
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut, Consorci Sanitari de Terrassa
- Responsible party
- Principal investigator, USR Metropolitana Nord, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Santiago Pérez, MD, Principal investigator, CAP La Llagosta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954967
- Sponsor's protocol ID
- PI08/90345
- Acronym
- ITADI
- Status last verified
- Oct 2018
- First submitted
- 6 Aug 2009
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roig L, Perez S, Prieto G, Martin C, Advani M, Armengol A, Roura P, Manresa JM, Briones E; ITADI Study Group. Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study. BMC Public Health. 2010 Feb 4;10:58. doi: 10.1186/1471-2458-10-58.
PubMed 20132540
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care
- ClinicalTrials.gov ID
- NCT00954967
- Acronym / sponsor ID
- ITADI / PI08/90345
- Conditions
- Diabetes Mellitus, Smoking Cessation
- Keywords
- Diabetes Mellitus, Smoking Cessation, Primary Health Care, Motivational Interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Catala de Salut, Consorci Sanitari de Terrassa
- Study start
- Sep 2009 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Aug 2009 (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.
This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. This study aims to evaluate the effectiveness of an intensive intervention in tobacco addiction in diabetic patients in primary care.
Detailed description
Other objectives of the study are:
- To study the effectiveness of an intensive smoking cessation intervention in the evolution of the phases of change, as based on the Prochaska and DiClemente model, in diabetic patients attended in primary care.
- To evaluate the effectiveness of an intensive smoking cessation intervention in the evolution of tabacco consumption in diabetic patients attended in primary care.
- To quantify the time spent in the intensive smoking cessation intervention compared with the usual care in primary care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –The subjects in the control group will receive the usual care for smoking cessation in diabetic smokers. |
| Lifestyle Counseling | Experimental | Behavioral: Lifestyle CounselingThe intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- diabetic patients who are active smokers
- over the age of 14
- receive routine care in their respective health center
Key exclusion criteria (6 listed)
- patients with communication difficulties (cognitive deterioration, language barrier)
- patients who normally receive their habitual care in a different health center
- patients with terminal diseases, psychiatric diseases that are unstable, or with addictions to other substances
- patients that are already receiving treatment to quit smoking at the time of recruitment
- patients that are difficult to locate during the study period
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 CounselingThe intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques. | Behavioural | Lifestyle Counseling |
Primary outcome
Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less
Time frame: 12 months after initiation of study
3 secondary outcomes
Evolution of the phases of change of the Prochaska and DiClemente model
Time frame: 12 months after initiation of the study
Number of cigarettes per day
Time frame: 12 months after initiation of the study
Total time (minutes) spent in the intensive smoking cessation intervention
Time frame: 12 months after initiation of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 20132540Roig L, Perez S, Prieto G, Martin C, Advani M, Armengol A, Roura P, Manresa JM, Briones E; ITADI Study Group. Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study. BMC Public Health. 2010 Feb 4;10:58. doi: 10.1186/1471-2458-10-58.
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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.
Santiago Pérez, MD principal investigator
CAP La Llagosta
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 Counseling in people with Diabetes Mellitus and Smoking Cessation, 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 6 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: finished, as of the sponsor's last update on 9 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less (time frame: 12 months after initiation of study). 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 NCT00954967, 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 9 Oct 2018.