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Diet Intervention Spirometry and Tobacco

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02151669
Acronym
DIET
Enrollment
80
Registered
2014-05-30
Start date
2013-11-30
Completion date
2016-11-30
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Function

Keywords

Mediterranean diet, Smoking/tobacco, Spirometry

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.

Interventions

BEHAVIORALMediterranean 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.

Sponsors

Preventive Services and Health Promotion Research Network
CollaboratorOTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in lung function2 yearsAssess the relationship between lung function and adherence to a Mediterranean Diet and its components

Secondary

MeasureTime frameDescription
Lung function and anthropometric parameters2 yearsAssess the relationship between lung function and anthropometric parameters such as waist circumference and BMI.
Lung function and effectiveness of a nutritional educational tool 2.02 yearsTo evaluate the effectiveness of using an nutritional educational tool 2.0 to increase adherence to a Mediterranean diet: blog.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026