Effectiveness of the Use of a Mobile Tool in Improving Lifestyles

NCT ID: NCT02016014

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 833 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-07-31

Brief Summary

Objectives: To develop and validate a mobile tool for use in Smartphone supports as a first step, and to evaluate the effect of adding this new tool of information and communication technologies (ICT), to a standardized intervention to increase adherence to nutritional recommendations of the Mediterranean diet and increase physical activity as primary endpoint. Analyze adherence and intervention results from a gender perspective. Methodology: Multicenter, randomized double-blind, clinical trial with two parallel group, aimed at assessing the effects of adding an TIC tool, developed for the Smartphone application (intervention), in support of behavioral and educational recommendations (control) in the increased physical activity and adaptation to the Mediterranean dietary pattern. Population: 1215 included subjects younger than 70 years from the project EVIDENT who agree to participate. Measurement and interventions: Physical activity will be assessed with the accelerometer and the 7-PAR day and adaptation to the Mediterranean diet with a questionnaire of adherence and a food frequency survey. It will also assess vascular structure and function, central blood pressure, Augmentation index, pulse rate and of carotid intima-media thickness. The counsel to adaptation the Mediterranean diet (based on the project PREDIMED) and exercise (based on PEPAF project), will be common to both groups. The intervention group will be added training and use of an application on a Smartphone designed to promote healthy eating and increased physical activity.

Conditions

Healthy Subjects Without Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Lifestyle counseling in physical activity and alimentation and add for three months a smartphopne with a app (EVIDENT) to improve alimentation and physical activity

Group Type: EXPERIMENTAL

Smartphone with APP

Intervention Type: DEVICE

Smartphone with APP (EVIDENT) for 3 months

Counseling on lifestyles

Intervention Type: BEHAVIORAL

Counseling on physical activity and mediterranean diet

Lifestyle counseling

Lifestyle counseling in physical activity and alimentation

Group Type: ACTIVE_COMPARATOR

Counseling on lifestyles

Intervention Type: BEHAVIORAL

Counseling on physical activity and mediterranean diet

Interventions

Smartphone with APP

Smartphone with APP (EVIDENT) for 3 months

Intervention Type: DEVICE

Counseling on lifestyles

Counseling on physical activity and mediterranean diet

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Healthy subjects since 20 to 70 years

Exclusion Criteria

Older than 70 years are excluded, due to difficulties in the use of ICTs and those who can not exercise or follow a diet Mediterranean diet

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Garcia-Ortiz, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Biosanitario de Salamanca

Locations

Instituto Biosanitario de Salamanca. Research unit La Alamedilla

Salamanca, , Spain

Countries

Spain

References

Garcia-Ortiz L, Recio-Rodriguez JI, Martin-Cantera C, Cabrejas-Sanchez A, Gomez-Arranz A, Gonzalez-Viejo N, Iturregui-San Nicolas E, Patino-Alonso MC, Gomez-Marcos MA; EVIDENT Group. Physical exercise, fitness and dietary pattern and their relationship with circadian blood pressure pattern, augmentation index and endothelial dysfunction biological markers: EVIDENT study protocol. BMC Public Health. 2010 May 6;10:233. doi: 10.1186/1471-2458-10-233.

Reference Type: BACKGROUND

PMID: 20459634 (View on PubMed)

Grandes G, Sanchez A, Sanchez-Pinilla RO, Torcal J, Montoya I, Lizarraga K, Serra J; PEPAF Group. Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med. 2009 Apr 13;169(7):694-701. doi: 10.1001/archinternmed.2009.23.

Reference Type: BACKGROUND

PMID: 19364999 (View on PubMed)

Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25.

Reference Type: RESULT

PMID: 23432189 (View on PubMed)

Gonzalez-Sanchez J, Recio-Rodriguez JI, Fernandez-delRio A, Sanchez-Perez A, Magdalena-Belio JF, Gomez-Marcos MA, Garcia-Ortiz L; On behalf the EVIDENT Investigators group. Using a smartphone app in changing cardiovascular risk factors: A randomized controlled trial (EVIDENT II study). Int J Med Inform. 2019 May;125:13-21. doi: 10.1016/j.ijmedinf.2019.02.004. Epub 2019 Feb 12.

Reference Type: DERIVED

PMID: 30914176 (View on PubMed)

Recio-Rodriguez JI, Rodriguez-Martin C, Gonzalez-Sanchez J, Rodriguez-Sanchez E, Martin-Borras C, Martinez-Vizcaino V, Arietaleanizbeaskoa MS, Magdalena-Gonzalez O, Fernandez-Alonso C, Maderuelo-Fernandez JA, Gomez-Marcos MA, Garcia-Ortiz L; EVIDENT Investigators. EVIDENT Smartphone App, a New Method for the Dietary Record: Comparison With a Food Frequency Questionnaire. JMIR Mhealth Uhealth. 2019 Feb 8;7(2):e11463. doi: 10.2196/11463.

Reference Type: DERIVED

PMID: 30735141 (View on PubMed)

Gomez-Marcos MA, Patino-Alonso MC, Recio-Rodriguez JI, Agudo-Conde C, Romaguera-Bosch M, Magdalena-Gonzalez O, Gomez-Arranz A, Mendizabal-Gallastegui N, Angel Fernandez-Diez J, Gomez-Sanchez L, Maderuelo-Fernandez JA, Rodriguez-Sanchez E, Garcia-Ortiz L; on behalf the EVIDENT Investigators 11. Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomised clinical trial - EVIDENT II study. Eur J Cardiovasc Nurs. 2018 Aug;17(6):552-562. doi: 10.1177/1474515118761870. Epub 2018 Feb 28.

Reference Type: DERIVED

PMID: 29488798 (View on PubMed)

Recio-Rodriguez JI, Agudo-Conde C, Martin-Cantera C, Gonzalez-Viejo MN, Fernandez-Alonso MD, Arietaleanizbeaskoa MS, Schmolling-Guinovart Y, Maderuelo-Fernandez JA, Rodriguez-Sanchez E, Gomez-Marcos MA, Garcia-Ortiz L; EVIDENT Investigators. Short-Term Effectiveness of a Mobile Phone App for Increasing Physical Activity and Adherence to the Mediterranean Diet in Primary Care: A Randomized Controlled Trial (EVIDENT II Study). J Med Internet Res. 2016 Dec 19;18(12):e331. doi: 10.2196/jmir.6814.

Reference Type: DERIVED

PMID: 27993759 (View on PubMed)

Sanchez-Aguadero N, Alonso-Dominguez R, Recio-Rodriguez JI, Patino-Alonso MC, Gomez-Marcos MA, Martin-Cantera C, Schmolling-Guinovart Y, Garcia-Ortiz L; EVIDENT II Group. Dietary glycemic index and retinal microvasculature in adults: a cross-sectional study. Nutr J. 2016 Oct 18;15(1):88. doi: 10.1186/s12937-016-0209-2.

Reference Type: DERIVED

PMID: 27756385 (View on PubMed)

Recio-Rodriguez JI, Martin-Cantera C, Gonzalez-Viejo N, Gomez-Arranz A, Arietaleanizbeascoa MS, Schmolling-Guinovart Y, Maderuelo-Fernandez JA, Perez-Arechaederra D, Rodriguez-Sanchez E, Gomez-Marcos MA, Garcia-Ortiz L; EVIDENT Group. Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol. BMC Public Health. 2014 Mar 15;14:254. doi: 10.1186/1471-2458-14-254.

Reference Type: DERIVED

PMID: 24628961 (View on PubMed)

Related Links

https://apisal.es/

Click here for more information about this study

Other Identifiers

GRS 770/B/13

Identifier Type: REGISTRY

Identifier Source: secondary_id

PI13/00618

Identifier Type: -

Identifier Source: org_study_id