Diet Intervention Spirometry and Tobacco

Pulmonary Function Clinical Trial

— DIET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151669
• Other study ID #: 4R13/068
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: November 2016

Study information

• Verified date: February 2023
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Function

Intervention

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.

Locations

Country	Name	City	State
Spain	Unitat de Recerca. CAP Sant Pere	Reus	Tarragona

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lung function	Assess the relationship between lung function and adherence to a Mediterranean Diet and its components	2 years
Secondary	Lung function and anthropometric parameters	Assess the relationship between lung function and anthropometric parameters such as waist circumference and BMI.	2 years
Secondary	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