EVIDENT 3 Study: A randomized, controlled clinical trial to reduce inactivity and caloric intake in sedentary and overweight or obese people using a smartphone application: Study protocol
Resumen: Introduction: Mobile technology, when included within multicomponent interventions, could contribute to more effective weight loss. The objective of this project is to assess the impact of adding the use of the EVIDENT 3 application, designed to promote healthy living habits, to traditional modification strategies employed for weight loss. Other targeted behaviors (walking, caloric-intake, sitting time) and outcomes (quality of life, inflammatory markers, measurements of arterial aging) will also be evaluated. Methods: Randomized, multicentre clinical trial with 2 parallel groups. The study will be conducted in the primary care setting and will include 700 subjects 20 to 65 years, with a body mass index (27.5-40kg/m2), who are clinically classified as sedentary. The primary outcome will be weight loss. Secondary outcomes will include change in walking (steps/d), sitting time (min/wk), caloric intake (kcal/d), quality of life, arterial aging (augmentation index), and pro-inflammatory marker levels. Outcomes will be measured at baseline, after 3 months, and after 1 year. Participants will be randomly assigned to either the intervention group (IG) or the control group (CG). Both groups will receive the traditional primary care lifestyle counseling prior to randomization. The subjects in the IG will be lent a smartphone and a smartband for a 3-month period, corresponding to the length of the intervention. The EVIDENT 3 application integrates the information collected by the smartband on physical activity and the self-reported information by participants on daily food intake. Using this information, the application generates recommendations and personalized goals for weight loss. Discussion: There is a great diversity in the applications used obtaining different results on lifestyle improvement and weight loss. The populations studied are not homogeneous and generate different results. The results of this study will help our understanding of the efficacy of new technologies, combined with traditional counseling, towards reducing obesity and enabling healthier lifestyles. Ethicsanddissemination: The study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca ("CREC of Health Area of Salamanca") on April 2016. A SPIRIT checklist is available for this protocol. The trial was registered in ClinicalTrials.gov provided by the US National Library of Medicine-number NCT03175614.
Idioma: Inglés
DOI: 10.1097/MD.0000000000009633
Año: 2018
Publicado en: Medicine 97, 2 (2018), e9633 [8 pp]
ISSN: 0025-7974

Factor impacto JCR: 1.87 (2018)
Categ. JCR: MEDICINE, GENERAL & INTERNAL rank: 69 / 159 = 0.434 (2018) - Q2 - T2
Factor impacto SCIMAGO: 0.19 - Medicine (miscellaneous) (Q3)

Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI16-00101
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI16-00170
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI16-00421
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI16-00659
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI16-00765
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/RD16-0007-0003
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/RD16-0007-0008
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/RD16-0007-0009
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/RD12-0005-0001
Tipo y forma: Artículo (Versión definitiva)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)

Creative Commons Debe reconocer adecuadamente la autoría, proporcionar un enlace a la licencia e indicar si se han realizado cambios. Puede hacerlo de cualquier manera razonable, pero no de una manera que sugiera que tiene el apoyo del licenciador o lo recibe por el uso que hace.


Exportado de SIDERAL (2020-01-03-14:01:00)


Visitas y descargas

Este artículo se encuentra en las siguientes colecciones:
Artículos



 Registro creado el 2018-04-10, última modificación el 2020-01-03


Versión publicada:
 PDF
Valore este documento:

Rate this document:
1
2
3
 
(Sin ninguna reseña)