Diet Intervention Spirometry and Tobacco

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-11-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Pulmonary Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mediterranean Diet

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes