Diet Intervention Spirometry and Tobacco (DIET)

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Completed

Conditions: Pulmonary Function

Treatments: Behavioral: Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02151669

4R13/068

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Mediterranean Diet Group

Experimental group

Description:

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.

Treatment:

Behavioral: Mediterranean Diet

Control group

No Intervention group

Description:

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.