000069665 001__ 69665
000069665 005__ 20200103141020.0
000069665 0247_ $$2doi$$a10.1097/MD.0000000000009633
000069665 0248_ $$2sideral$$a104648
000069665 037__ $$aART-2018-104648
000069665 041__ $$aeng
000069665 100__ $$aRecio-Rodriguez, J.I.
000069665 245__ $$aEVIDENT 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
000069665 260__ $$c2018
000069665 5060_ $$aAccess copy available to the general public$$fUnrestricted
000069665 5203_ $$aIntroduction: 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.
000069665 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII/PI16-00101$$9info:eu-repo/grantAgreement/ES/ISCIII/PI16-00170$$9info:eu-repo/grantAgreement/ES/ISCIII/PI16-00421$$9info:eu-repo/grantAgreement/ES/ISCIII/PI16-00659$$9info:eu-repo/grantAgreement/ES/ISCIII/PI16-00765$$9info:eu-repo/grantAgreement/ES/ISCIII/RD16-0007-0003$$9info:eu-repo/grantAgreement/ES/ISCIII/RD16-0007-0008$$9info:eu-repo/grantAgreement/ES/ISCIII/RD16-0007-0009$$9info:eu-repo/grantAgreement/ES/ISCIII/RD12-0005-0001
000069665 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/
000069665 590__ $$a1.87$$b2018
000069665 591__ $$aMEDICINE, GENERAL & INTERNAL$$b69 / 159 = 0.434$$c2018$$dQ2$$eT2
000069665 592__ $$a0.19$$b2018
000069665 593__ $$aMedicine (miscellaneous)$$c2018$$dQ3
000069665 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000069665 700__ $$aGómez-Marcos, M.A.
000069665 700__ $$aAgudo-Conde, C.
000069665 700__ $$aRamirez, I.
000069665 700__ $$0(orcid)0000-0003-2299-2410$$aGonzalez-Viejo, N.$$uUniversidad de Zaragoza
000069665 700__ $$aGomez-Arranz, A.
000069665 700__ $$aSalcedo-Aguilar, F.
000069665 700__ $$aRodriguez-Sanchez, E.
000069665 700__ $$aAlonso-Domínguez, R.
000069665 700__ $$aSánchez-Aguadero, N.
000069665 700__ $$aGonzalez-Sanchez, J.
000069665 700__ $$aGarcia-Ortiz, L.
000069665 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000069665 773__ $$g97, 2 (2018), e9633 [8 pp]$$pMedicine (Baltim.)$$tMedicine$$x0025-7974
000069665 8564_ $$s429058$$uhttps://zaguan.unizar.es/record/69665/files/texto_completo.pdf$$yVersión publicada
000069665 8564_ $$s116965$$uhttps://zaguan.unizar.es/record/69665/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000069665 909CO $$ooai:zaguan.unizar.es:69665$$particulos$$pdriver
000069665 951__ $$a2020-01-03-14:01:00
000069665 980__ $$aARTICLE