Clinical trial NCT02151669: Diet Intervention Spirometry and Tobacco
Official title: EFFECT OF A MEDITERRANEAN DIET INTERVENTION IN PULMONARY FUNCTION IN SMOKERS: A MULTICENTER RANDOMIZED CLINICAL TRIAL IN PRIMARY CARE CENTERS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Function
Keywords: Mediterranean diet
Smoking/tobacco
Spirometry
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
First posted: 2014-05-30
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility 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

Primary outcomes:
measure: Changes in lung function
timeFrame: 2 years
Secondary outcomes:
measure: Lung function and anthropometric parameters
timeFrame: 2 years
measure: Lung function and effectiveness of a nutritional educational tool 2.0
timeFrame: 2 years
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Unitat de Recerca. CAP Sant Pere
state: Tarragona
Study officials:
affiliation: Catalan Institute of Health
name: Francisco Martín Luján, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salamanca-Gonzalez P, Valls-Zamora RM, Pedret-Figuerola A, Sorli-Aguilar M, Santigosa-Ayala A, Catalin RE, Palleja-Millan M, Sola-Alberich R, Martin-Lujan F, The Cenit Research Group Investigators. Effectiveness of a Motivational Nutritional Intervention through Social Networks 2.0 to Increase Adherence to the Mediterranean Diet and Improve Lung Function in Active Smokers: The DIET Study, a Randomized, Controlled and Parallel Clinical Trial in Primary Care. Nutrients. 2021 Oct 14;13(10):3597. doi: 10.3390/nu13103597.
citation: Sorli-Aguilar M, Martin-Lujan F, Flores-Mateo G, Arija-Val V, Basora-Gallisa J, Sola-Alberich R; RESET Study Group investigators. Dietary patterns are associated with lung function among Spanish smokers without respiratory disease. BMC Pulm Med. 2016 Nov 25;16(1):162. doi: 10.1186/s12890-016-0326-x.
citation: Sorli-Aguilar M, Martin-Lujan F, Santigosa-Ayala A, Pinol-Moreso JL, Flores-Mateo G, Basora-Gallisa J, Arija-Val V, Sola-Alberich R. Effects of mediterranean diet on lung function in smokers: a randomised, parallel and controlled protocol. BMC Public Health. 2015 Jan 31;15:74. doi: 10.1186/s12889-015-1450-x.