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CompletedNCT00954967ITADIUpdated Oct 9, 2018

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

An interventional study of Lifestyle Counseling in Diabetes Mellitus and Smoking Cessation, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Completed at 1 site in Spain. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
722
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study 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.

Read the 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.
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Conditions studied

  • Diabetes Mellitus
  • Smoking Cessation

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Keywords

  • Diabetes Mellitus
  • Smoking Cessation
  • Primary Health Care
  • Motivational Interview
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 722 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
722 participants (actual)

Study arms

  • No intervention
    Usual care

    The subjects in the control group will receive the usual care for smoking cessation in diabetic smokers.

  • Experimental
    Lifestyle 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.

    Behavioral: Lifestyle Counseling

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.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Evolution of the phases of change of the Prochaska and DiClemente model

    Time frame: 12 months after initiation of the study

  2. Number of cigarettes per day

    Time frame: 12 months after initiation of the study

  3. Total time (minutes) spent in the intensive smoking cessation intervention

    Time frame: 12 months after initiation of the study

07

Study locations

1 site
  • IDIAP Jordi Gol
    Barcelona, 08007, Spain
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00954967
Lead sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Institut Catala de Salut, Consorci Sanitari de Terrassa
Responsible party
USR Metropolitana Nord (Doctor, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina) — Principal investigator
First posted
Aug 7, 2009
Start date
Sep 2009
Primary completion
Jan 2011
Completion
Sep 2011
Last update
Oct 9, 2018

Study contacts

Santiago Pérez, MD
principal investigator · CAP La Llagosta

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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