Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

Having participated in the first phase of the project: RESET study (PI11/01962).
Being active smokers at the time of enrollment with an cumulative consumption more than 10 packs / year
Having Internet access and regular use of new technologies in general or have help for it.
Having participated in the first phase of the project: RESET study (PI11/01962).
Being active smokers at the time of enrollment with an cumulative consumption more than 10 packs / year
Having Internet access and regular use of new technologies in general or have help for it.

Exclusion Criterias

Suffering from a terminal or chronic disorder that alters the baseline parameters or hinder the completion of testing and required test during the study period,
Inability to track for any reason,
Any evidence of previous diagnosis of respiratory disease,
...
Suffering from a terminal or chronic disorder that alters the baseline parameters or hinder the completion of testing and required test during the study period,
Inability to track for any reason,
Any evidence of previous diagnosis of respiratory disease,
Express refusal of the patient to continue in the study

Summary

Conditions
Pulmonary Function
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 35 years and 70 years
Gender
Both males and females

Description

Design: Multicenter randomized controlled trial in primary care. Sample: We will recruit 80 smokers from 35 to 70 years without history of lung disease. Subjects will be randomly assigned to control or intervention group (1:1). Study variables: We measure socio-demographic, clinical, anthropometry a...

Design: Multicenter randomized controlled trial in primary care. Sample: We will recruit 80 smokers from 35 to 70 years without history of lung disease. Subjects will be randomly assigned to control or intervention group (1:1). Study variables: We measure socio-demographic, clinical, anthropometry and spirometry data. Food consumption will be evaluated by a semi-quantitative food frequency questionnaire (FFQ), energy expenditure in physical activity by the Minnesota Leisure Time Activity questionnaire and adherence to Mediterranean Diet by a 14-item questionnaire. Intervention: Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years. Analysis: All analyses will be based on intention-to-treat. The results will be considered clinically relevant when it detects a difference in lung function (decreased FEV1) >10-12 ml/year. A p-value of <0.05 will defined statistical significance.

Inclusion Criterias

Having participated in the first phase of the project: RESET study (PI11/01962).
Being active smokers at the time of enrollment with an cumulative consumption more than 10 packs / year
Having Internet access and regular use of new technologies in general or have help for it.
Having participated in the first phase of the project: RESET study (PI11/01962).
Being active smokers at the time of enrollment with an cumulative consumption more than 10 packs / year
Having Internet access and regular use of new technologies in general or have help for it.

Exclusion Criterias

Suffering from a terminal or chronic disorder that alters the baseline parameters or hinder the completion of testing and required test during the study period,
Inability to track for any reason,
Any evidence of previous diagnosis of respiratory disease,
...
Suffering from a terminal or chronic disorder that alters the baseline parameters or hinder the completion of testing and required test during the study period,
Inability to track for any reason,
Any evidence of previous diagnosis of respiratory disease,
Express refusal of the patient to continue in the study

Locations

Reus, Tarragona, 43202
Reus, Tarragona, 43202

Tracking Information

NCT #
NCT02151669
Collaborators
Preventive Services and Health Promotion Research Network
Investigators
  • Principal Investigator: Francisco Martín Luján, MD Catalan Institute of Health
  • Francisco Martín Luján, MD Catalan Institute of Health