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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00954967
• Date of registration: 06/08/2009
• Prospective Registration: Yes
• Primary sponsor: Jordi Gol i Gurina Foundation
• Public title: Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project ITADI
• Scientific title: Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care
• Date of first enrolment: September 2009
• Target sample size: 722
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00954967
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Santiago Pérez, MD
• Affiliation: CAP La Llagosta

Key inclusion & exclusion criteria

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



Age minimum: 14 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Smoking Cessation

Diabetes Mellitus

Intervention(s)

Behavioral: Lifestyle Counseling

Primary Outcome(s)

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]

Secondary Outcome(s)

Number of cigarettes per day [Time Frame: 12 months after initiation of the study]

Evolution of the phases of change of the Prochaska and DiClemente model [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]

Secondary ID(s)

PI08/90345

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Consorci Sanitari de Terrassa

Institut Catala de Salut