Effect of the Mediterranean Diet on Lung Function in Smokers Without Previous Respiratory Disease
NCT ID: NCT03362372
Last Updated: 2023-03-14
Study Results
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Basic Information
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COMPLETED
NA
566 participants
INTERVENTIONAL
2017-06-01
2020-07-01
Brief Summary
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Objective: To evaluate the effect of adherence to DiMet on the deterioration of lung function in smokers.
Methodology: Design: Controlled, parallel, multicenter, cluster-randomized clinical trial. Participants: 566 active smokers with a cumulative consumption of more than 10 packets a year, within 25 to 75 year-old age group, without previous respiratory disease and who agree with the conditions of the study and sign an informed consent . Scope: 20 Primary Care Centers managed by the Catalan Health Institutes in Tarragona that will be randomly assigned to a control or an intervention group (1: 1). Intervention: During 2 years a nutritional intervention will be carried out to increase adherence to DiMet based on: 1) annual visit of personalized nutritional education, 2) annual telephone contact for intervention reinforcement, and 3) computer access to a dietary block designed ad hoc. The control group will follow their usual diet style. All participants will receive advice to quit smoking. It will be evaluated: a) pulmonary function by forced spirometry and b) adherence to the DiMet with a questionnaire of 14 items and biological determinations. Statistical analysis: For intention to treat. The unit of analysis will be the individual smoker. Parameters of pulmonary function and adherence to the DiMet of both groups will be compared.
Expected results: DiMet prevents the appearance of altered lung function in smokers without previous respiratory pathology. Thus, DiMet will be key in pulmonary prevention, together with the fundamental recommendation of smoking cessation.
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Detailed Description
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Objective: To evaluate the effect of adherence to DiMet on the deterioration of lung function in smokers.
Methodology: Design: Controlled, parallel, multicenter, cluster-randomized clinical trial. Participants: 566 active smokers with a cumulative consumption of more than 10 packets a year, within 25 to 75 year-old age group, without previous respiratory disease and who agree with the conditions of the study and sign an informed consent . Scope: 20 Primary Care Centers managed by the Catalan Health Institutes in Tarragona that will be randomly assigned to a control or an intervention group (1: 1). Intervention: During 2 years a nutritional intervention will be carried out to increase adherence to DiMet based on: 1) annual visit of personalized nutritional education, 2) annual telephone contact for intervention reinforcement, and 3) computer access to a dietary block designed ad hoc. The control group will follow their usual diet style. All participants will receive advice to quit smoking. It will be evaluated: a) pulmonary function by forced spirometry and b) adherence to the DiMet with a questionnaire of 14 items and biological determinations. Statistical analysis: For intention to treat. The unit of analysis will be the individual smoker. Parameters of pulmonary function and adherence to the DiMet of both groups will be compared.
Expected results: DiMet prevents the appearance of altered lung function in smokers without previous respiratory pathology. Thus, DiMet will be key in pulmonary prevention, together with the fundamental recommendation of smoking cessation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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INTERVENTION GROUP: MEDITERRANEAN DIET COUNSELING
During 2 years a nutritional intervention will be carried out to increase adherence to DiMet based on: annual visit of personalized nutritional education, a telephone contact for intervention reinforcement and computer access to a nutrition blog
Mediterranean diet counseling
The participants of the intervention CAP will enter into an educational program to increase adherence to the DiMet that will integrate three operational components:
1. Explain the particularities of DiMet and the benefits of its monitoring. It will be an individual visit of 25-30 minutes (V1) where the study variables will be collected and the medical tests will be performed and repeated annually for two years (V3 and V5).
2. Clarify the doubts of the DiMet monitoring and the advice received. It will be a telephone visit to reinforce the intervention, with annual frequency, for two years (V2 and V4).
3. Report on DiMet's own foods, cooking habits, adapted recipes and other related topics. It will be for access to an ad hoc designed nutrition blog.
CONTROL GROUP: WITHOUT CHANGES IN DIET
The participants of health centers will carry out the same 5 visits (3 individual visits and 2 phone calls), although no changes are induced in their usual diet and they will not be offered access to the nutritional blog.
No interventions assigned to this group
Interventions
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Mediterranean diet counseling
The participants of the intervention CAP will enter into an educational program to increase adherence to the DiMet that will integrate three operational components:
1. Explain the particularities of DiMet and the benefits of its monitoring. It will be an individual visit of 25-30 minutes (V1) where the study variables will be collected and the medical tests will be performed and repeated annually for two years (V3 and V5).
2. Clarify the doubts of the DiMet monitoring and the advice received. It will be a telephone visit to reinforce the intervention, with annual frequency, for two years (V2 and V4).
3. Report on DiMet's own foods, cooking habits, adapted recipes and other related topics. It will be for access to an ad hoc designed nutrition blog.
Eligibility Criteria
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Inclusion Criteria
* Age between 25-75 years.
* Internet connection.
Exclusion Criteria
* Chronic or terminal disorder that alters basal parameters.
* Any reason that limits follow up.
25 Years
75 Years
ALL
Yes
Sponsors
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Preventive Services and Health Promotion Research Network
OTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Principal Investigators
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Francisco Martín Luján
Role: PRINCIPAL_INVESTIGATOR
Catalan Institute of Health
Locations
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Jordi Gol i Gurina Foundation
Barcelona, , Spain
Countries
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References
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Martin-Lujan F, Catalin RE, Salamanca-Gonzalez P, Sorli-Aguilar M, Santigosa-Ayala A, Valls-Zamora RM, Martin-Vergara N, Canela-Armengol T, Arija-Val V, Sola-Alberich R. A clinical trial to evaluate the effect of the Mediterranean diet on smokers lung function. NPJ Prim Care Respir Med. 2019 Nov 27;29(1):40. doi: 10.1038/s41533-019-0153-7.
Catalin RE, Martin-Lujan F, Salamanca-Gonzalez P, Palleja-Millan M, Villalobos F, Santigosa-Ayala A, Pedret A, Valls-Zamora RM, Sola R, On Behalf Of The Medistar Research Group Investigators. Mediterranean Diet and Lung Function in Adults Current Smokers: A Cross-Sectional Analysis in the MEDISTAR Project. Nutrients. 2023 Mar 3;15(5):1272. doi: 10.3390/nu15051272.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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SLT002/16/00155
Identifier Type: -
Identifier Source: org_study_id
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