Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diet Intervention Spirometry and Tobacco (DIET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02151669
Recruitment Status : Unknown
Verified May 2014 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Active, not recruiting
First Posted : May 30, 2014
Last Update Posted : May 30, 2014
Sponsor:
Collaborator:
Preventive Services and Health Promotion Research Network
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Pulmonary Function Behavioral: Mediterranean Diet Not Applicable

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of a Mediterranean Diet Intervention Pulmonary Function in Smokers:A Multicenter Randomized Clinical Trial in Primary Care Centers
Study Start Date : November 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : November 2016
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Mediterranean Diet Group
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
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: Control group
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in lung function [ Time Frame: 2 years ]
    Assess the relationship between lung function and adherence to a Mediterranean Diet and its components


Secondary Outcome Measures :
  1. Lung function and anthropometric parameters [ Time Frame: 2 years ]
    Assess the relationship between lung function and anthropometric parameters such as waist circumference and BMI.

  2. Lung function and effectiveness of a nutritional educational tool 2.0 [ Time Frame: 2 years ]
    To evaluate the effectiveness of using an nutritional educational tool 2.0 to increase adherence to a Mediterranean diet: blog.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151669


Locations
Layout table for location information
Spain
Unitat de Recerca. CAP Sant Pere
Reus, Tarragona, Spain, 43202
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
Investigators
Layout table for investigator information
Principal Investigator: Francisco Martín Luján, MD Catalan Institute of Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT02151669    
Other Study ID Numbers: 4R13/068
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014
Keywords provided by Jordi Gol i Gurina Foundation:
Mediterranean diet
Smoking/tobacco
Spirometry