Diet Intervention Spirometry and Tobacco

Study Overview
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Brief Summary
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Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern in lung function in smokers. Phase II of the RESET study , a clinical trial to evaluate the efficacy of a motivational smoking intervention based on information obtained by spirometry (FIS project PI11/01962).

Detailed Description
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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.

Official Title
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EFFECT OF A MEDITERRANEAN DIET INTERVENTION IN PULMONARY FUNCTION IN SMOKERS: A MULTICENTER RANDOMIZED CLINICAL TRIAL IN PRIMARY CARE CENTERS

Conditions
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Pulmonary Function

Intervention / Treatment
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* Behavioral: Mediterranean Diet


Participation Criteria
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Eligibility Criteria
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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). Exclusion Criteria: 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, Express refusal of the patient to continue in the study

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Diet Group<br>Nutritional intervention 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. | Behavioral: Mediterranean Diet<br>* 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.<br>|
| No Intervention: Control group<br>Participants of control group will be referred to your doctor or nurse with reference to a report on specific according to your personal situation dietary recommendations. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lung function | Assess the relationship between lung function and adherence to a Mediterranean Diet and its components | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function and anthropometric parameters | Assess the relationship between lung function and anthropometric parameters such as waist circumference and BMI. | 2 years | 
| Lung function and effectiveness of a nutritional educational tool 2.0 | To evaluate the effectiveness of using an nutritional educational tool 2.0 to increase adherence to a Mediterranean diet: blog. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mediterranean diet, Smoking/tobacco, Spirometry