Diet Intervention Spirometry and Tobacco
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- 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.
- Having participated in the first phase of the project: RESET study (PI11/01962).
Exclusion Criteria
- Any evidence of previous diagnosis of respiratory disease,
- Express refusal of the patient to continue in the study
- 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,
- ...
- Any evidence of previous diagnosis of respiratory disease,
- Express refusal of the patient to continue in the study
- 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,
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 Criteria
- 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.
- Having participated in the first phase of the project: RESET study (PI11/01962).
Exclusion Criteria
- Any evidence of previous diagnosis of respiratory disease,
- Express refusal of the patient to continue in the study
- 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,
- ...
- Any evidence of previous diagnosis of respiratory disease,
- Express refusal of the patient to continue in the study
- 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,
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
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