Overview

This trial is active, not recruiting.

Condition pulmonary function
Treatment mediterranean diet
Sponsor Jordi Gol i Gurina Foundation
Collaborator Preventive Services and Health Promotion Research Network redIAPP G03/70
Start date November 2013
End date May 2015
Trial size 80 participants
Trial identifier NCT02151669, 4R13/068

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
mediterranean diet
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.
(No Intervention)
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.

Primary Outcomes

Measure
Changes in lung function
time frame: 2 years

Secondary Outcomes

Measure
Lung function and anthropometric parameters
time frame: 2 years
Lung function and effectiveness of a nutritional educational tool 2.0
time frame: 2 years

Eligibility Criteria

Male or female participants from 35 years up to 70 years old.

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

Additional Information

Official title Effect of a Mediterranean Diet Intervention Pulmonary Function in Smokers:A Multicenter Randomized Clinical Trial in Primary Care Centers
Principal investigator Francisco Martín Luján, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Jordi Gol i Gurina Foundation.