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Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project

Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00954967
Acronym
ITADI
Enrollment
722
Registered
2009-08-07
Start date
2009-09-30
Completion date
2011-09-30
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Smoking Cessation

Keywords

Diabetes Mellitus, Smoking Cessation, Primary Health Care, Motivational Interview

Brief 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. 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: 1. 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. 2. To evaluate the effectiveness of an intensive smoking cessation intervention in the evolution of tabacco consumption in diabetic patients attended in primary care. 3. To quantify the time spent in the intensive smoking cessation intervention compared with the usual care in primary care.

Interventions

BEHAVIORALLifestyle Counseling

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.

Sponsors

Institut Catala de Salut
CollaboratorOTHER_GOV
Consorci Sanitari de Terrassa
CollaboratorOTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diabetic patients who are active smokers * over the age of 14 * receive routine care in their respective health center

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
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 less12 months after initiation of study

Secondary

MeasureTime frame
Evolution of the phases of change of the Prochaska and DiClemente model12 months after initiation of the study
Number of cigarettes per day12 months after initiation of the study
Total time (minutes) spent in the intensive smoking cessation intervention12 months after initiation of the study

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026