Diet Intervention Spirometry and Tobacco (DIET)

EFFECT OF A MEDITERRANEAN DIET INTERVENTION IN PULMONARY FUNCTION IN SMOKERS: A MULTICENTER RANDOMIZED CLINICAL TRIAL IN PRIMARY CARE CENTERS

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Function
• Intervention / Treatment: Behavioral: Mediterranean Diet

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43202
      • Unitat de Recerca. CAP Sant Pere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lung function	Assess the relationship between lung function and adherence to a Mediterranean Diet and its components	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function and anthropometric parameters	Assess the relationship between lung function and anthropometric parameters such as waist circumference and BMI.	2 years
Lung function and effectiveness of a nutritional educational tool 2.0	To evaluate the effectiveness of using an nutritional educational tool 2.0 to increase adherence to a Mediterranean diet: blog.	2 years

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Preventive Services and Health Promotion Research Network
• Investigators: Principal Investigator: Francisco Martín Luján, MD, Catalan Institute of Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 26, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Spirometry; Mediterranean diet; Smoking/tobacco
• Other Study ID Numbers: 4R13/068