NCT02151669

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

May 26, 2014

Last Update Submit

February 24, 2023

Conditions

Pulmonary Function

Keywords

Mediterranean dietSmoking/tobaccoSpirometry

Outcome Measures

Primary Outcomes (1)

  • Changes in lung function

    Assess the relationship between lung function and adherence to a Mediterranean Diet and its components

    2 years

Secondary Outcomes (2)

  • Lung function and anthropometric parameters

    2 years

  • Lung function and effectiveness of a nutritional educational tool 2.0

    2 years

Study Arms (2)

Mediterranean Diet Group

EXPERIMENTAL

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.

Behavioral: Mediterranean Diet

Control group

NO INTERVENTION

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.

Interventions

Mediterranean DietBEHAVIORAL

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.

Mediterranean Diet Group

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unitat de Recerca. CAP Sant Pere

Reus, Tarragona, 43202, Spain

Location

Related Publications (3)

  • 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 through Social Networks 2.0 to Increase Adherence to the Mediterranean Diet and Improve Lung Function in Active Smokers: The DIET Study, a Randomized, Controlled and Parallel Clinical Trial in Primary Care. Nutrients. 2021 Oct 14;13(10):3597. doi: 10.3390/nu13103597.

    PMID: 34684600RESULT

  • 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 25;16(1):162. doi: 10.1186/s12890-016-0326-x.

    PMID: 27884188RESULT

  • Sorli-Aguilar M, Martin-Lujan F, Santigosa-Ayala A, Pinol-Moreso JL, Flores-Mateo G, Basora-Gallisa J, Arija-Val V, Sola-Alberich R. Effects of mediterranean diet on lung function in smokers: a randomised, parallel and controlled protocol. BMC Public Health. 2015 Jan 31;15:74. doi: 10.1186/s12889-015-1450-x.

    PMID: 25636808DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Francisco Martín Luján, MD

    Catalan Institute of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 30, 2014

Study Start

November 1, 2013

Primary Completion

May 1, 2015

Study Completion

November 1, 2016

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

ES(1)