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| Name | Class |
|---|---|
| Preventive Services and Health Promotion Research Network | OTHER |
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Several studies have shown the influence of the eating pattern on lung function. However, the benefits of the Mediterranean diet (DiMet) in preventing pulmonary dysfunction are not well known.
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.
Several studies have shown the influence of the eating pattern on lung function. However, the benefits of the Mediterranean diet (DiMet) in preventing pulmonary dysfunction are not well known.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTERVENTION GROUP: MEDITERRANEAN DIET COUNSELING | Experimental | 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 |
|
| CONTROL GROUP: WITHOUT CHANGES IN DIET | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet counseling | Behavioral | The participants of the intervention CAP will enter into an educational program to increase adherence to the DiMet that will integrate three operational components:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in lung function values in smokers without previous respiratory disease | Changes in lung function measured by spirometry. An altered lung function was considered if values of FVC <80% and / or FEV1 <80% and / or FEV1 / FVC <0.7 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional intervention | The effectiveness of the intervention will be measured by dietary changes by a food frequency questionnaire | 2 years |
| Nutritional intervention | Adherence to the Mediterranean diet will be measured by dietary changes in a mediterranean diet adherence score of 14-Ãtem |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco MartÃn Luján | Catalan Institute of Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordi Gol i Gurina Foundation | Barcelona | 08007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31776344 | Result | 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. | |
| 36904270 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 28, 2017 | Nov 28, 2017 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Controlled, parallel, multicenter, cluster-randomized clinical trial.
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|
| 2 years |
| Anthropometric parameters | Changes in anthropometric parameters: weight in kilograms and height in meters. Weight and height will be combined to report BMI in kg/m2 | 2 years |
| Anthropometric parameters | Changes in anthropometric parameters: abdominal perimeter | 2 years |
| Changes in food consumption markers | Changes in food consumption markers: excreted of total polyphenols in fresh urine. | 2 years |
| Changes in inflammation markers | Changes in serum inflammation markers: high-sensitivity C-reactive protein | 2 years |
| Changes in inflammation markers | Changes in serum inflammation markers: interleukin-6 | 2 years |
| 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. |