Diet Intervention Spirometry and Tobacco

Not Applicable

Completed

• Conditions: Pulmonary Function
• Interventions: Behavioral: Mediterranean Diet

• Registration Number: NCT02151669
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-05-30
• Primary Completion: 2015-05
• Study Completion: 2016-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean Diet Group	Mediterranean Diet	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.

Primary Outcome Measures

Name	Time	Method
Changes in lung function	2 years	Assess the relationship between lung function and adherence to a Mediterranean Diet and its components

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Unitat de Recerca. CAP Sant Pere; 🇪🇸 Reus, Tarragona, Spain