000097469 001__ 97469 000097469 005__ 20210902121924.0 000097469 0247_ $$2doi$$a10.2196/21771 000097469 0248_ $$2sideral$$a121712 000097469 037__ $$aART-2020-121712 000097469 041__ $$aeng 000097469 100__ $$aLugones-Sanchez, C. 000097469 245__ $$aEffectiveness of an mHealth intervention combining a smartphone app and smart band on body composition in an overweight and obese population: Randomized controlled trial (EVIDENT 3 study) 000097469 260__ $$c2020 000097469 5060_ $$aAccess copy available to the general public$$fUnrestricted 000097469 5203_ $$aBackground: Mobile health (mHealth) is currently among the supporting elements that may contribute to an improvement in health markers by helping people adopt healthier lifestyles. mHealth interventions have been widely reported to achieve greater weight loss than other approaches, but their effect on body composition remains unclear. Objective: This study aimed to assess the short-term (3 months) effectiveness of a mobile app and a smart band for losing weight and changing body composition in sedentary Spanish adults who are overweight or obese. Methods: A randomized controlled, multicenter clinical trial was conducted involving the participation of 440 subjects from primary care centers, with 231 subjects in the intervention group (IG; counselling with smartphone app and smart band) and 209 in the control group (CG; counselling only). Both groups were counselled about healthy diet and physical activity. For the 3-month intervention period, the IG was trained to use a smartphone app that involved self-monitoring and tailored feedback, as well as a smart band that recorded daily physical activity (Mi Band 2, Xiaomi). Body composition was measured using the InBody 230 bioimpedance device (InBody Co., Ltd), and physical activity was measured using the International Physical Activity Questionnaire. Results: The mHealth intervention produced a greater loss of body weight (–1.97 kg, 95% CI –2.39 to –1.54) relative to standard counselling at 3 months (–1.13 kg, 95% CI –1.56 to –0.69). Comparing groups, the IG achieved a weight loss of 0.84 kg more than the CG at 3 months. The IG showed a decrease in body fat mass (BFM; –1.84 kg, 95% CI –2.48 to –1.20), percentage of body fat (PBF; –1.22%, 95% CI –1.82% to 0.62%), and BMI (–0.77 kg/m2, 95% CI –0.96 to 0.57). No significant changes were observed in any of these parameters in men; among women, there was a significant decrease in BMI in the IG compared with the CG. When subjects were grouped according to baseline BMI, the overweight group experienced a change in BFM of –1.18 kg (95% CI –2.30 to –0.06) and BMI of –0.47 kg/m2 (95% CI –0.80 to –0.13), whereas the obese group only experienced a change in BMI of –0.53 kg/m2 (95% CI –0.86 to –0.19). When the data were analyzed according to physical activity, the moderate-vigorous physical activity group showed significant changes in BFM of –1.03 kg (95% CI –1.74 to –0.33), PBF of –0.76% (95% CI –1.32% to –0.20%), and BMI of –0.5 kg/m2 (95% CI –0.83 to –0.19). Conclusions: The results from this multicenter, randomized controlled clinical trial study show that compared with standard counselling alone, adding a self-reported app and a smart band obtained beneficial results in terms of weight loss and a reduction in BFM and PBF in female subjects with a BMI less than 30 kg/m2 and a moderate-vigorous physical activity level. Nevertheless, further studies are needed to ensure that this profile benefits more than others from this intervention and to investigate modifications of this intervention to achieve a global effect. 000097469 536__ $$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/FI17-00040-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/PI16-00101-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/PI16-00170-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/PI16-00421-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/PI16-00659-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/PI16-00765-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/PI16-00952-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/RD12-0005-0001-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/RD16-0007-0003-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/RD16-0007-0005-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/RD16-0007-0008-Investing in your future$$9info:eu-repo/grantAgreement/ES/MICINN-ISCIII-ERDF-ESF/RD16-0007-0009-Investing in your future 000097469 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000097469 590__ $$a4.773$$b2020 000097469 591__ $$aMEDICAL INFORMATICS$$b8 / 30 = 0.267$$c2020$$dQ2$$eT1 000097469 591__ $$aHEALTH CARE SCIENCES & SERVICES$$b17 / 108 = 0.157$$c2020$$dQ1$$eT1 000097469 592__ $$a1.356$$b2020 000097469 593__ $$aHealth Informatics$$c2020$$dQ1 000097469 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000097469 700__ $$0(orcid)0000-0001-8756-114X$$aSanchez-Calavera, M.A.$$uUniversidad de Zaragoza 000097469 700__ $$aRepiso-Gento, I. 000097469 700__ $$aAdalia, E.G. 000097469 700__ $$aIgnacio Ramirez-Manent, J. 000097469 700__ $$aAgudo-Conde, C. 000097469 700__ $$aRodriguez-Sanchez, E. 000097469 700__ $$aGomez-Marcos, M.A. 000097469 700__ $$aRecio-Rodriguez, J.I. 000097469 700__ $$aGarcia-Ortiz, L. 000097469 700__ $$aOrtiz, L.G. 000097469 700__ $$aRecio Rodriguez, J.I. 000097469 700__ $$aLugones-Sanchez, C. 000097469 700__ $$aGomez-Marcos, M.A. 000097469 700__ $$aAgudo-Conde, C. 000097469 700__ $$aAlonso-Dominguez, R. 000097469 700__ $$aSanchez-Aguadero, N. 000097469 700__ $$ade Cabo-Laso, A. 000097469 700__ $$aRodriguez-Martin, C. 000097469 700__ $$aCastaño-Sanchez, C. 000097469 700__ $$aSanchez-Salgado, B. 000097469 700__ $$aRodriguez-Sanchez, E. 000097469 700__ $$aGonzalez-Sanchez, S. 000097469 700__ $$aGonzalez-Sanchez, J. 000097469 700__ $$aPatino-Alonso, M.C. 000097469 700__ $$aMaderuelo-Fernandez, J.A. 000097469 700__ $$aHipola-Muñoz, R. 000097469 700__ $$aGomez-Sanchez, L. 000097469 700__ $$aTamayo-Morales, O. 000097469 700__ $$aLlamas-Ramos, I. 000097469 700__ $$aGonzález-Viejo, N. 000097469 700__ $$aMagdalena-Belio, J.F. 000097469 700__ $$aOtegui-Ilarduya, L. 000097469 700__ $$aRubio-Galan, F.J. 000097469 700__ $$aSauras-Yera, C.I. 000097469 700__ $$aMelguizo-Bejar, A. 000097469 700__ $$aGil-Train, M.J. 000097469 700__ $$aIribarne-Ferrer, M. 000097469 700__ $$aMagdalena-González, O. 000097469 700__ $$aLafuente-Ripolles, M.A. 000097469 700__ $$aMar Martínez, M. 000097469 700__ $$aSalcedo-Aguilar, F. 000097469 700__ $$aMuelas-Herraiz, F. 000097469 700__ $$aMolina-Morate, M.A. 000097469 700__ $$aPérez-Parra, A. 000097469 700__ $$aMadero, F. 000097469 700__ $$aGarcia-Imbroda, A. 000097469 700__ $$aIzquierdo, J.M. 000097469 700__ $$aMonterde, M.L. 000097469 700__ $$aRodriguez-Vizcaino, V. 000097469 700__ $$aSoriano-Cano, A. 000097469 700__ $$aPozuelo-Carrascosa, D.P. 000097469 700__ $$aGalvez-Adalia, E. 000097469 700__ $$adel Saz-Lara, A. 000097469 700__ $$aDíez-Fernandez, A. 000097469 700__ $$aAlvarez-Bueno, C. 000097469 700__ $$aCavero-Redondo, I. 000097469 700__ $$aRamírez-Manent, J.I. 000097469 700__ $$aFerrer-Perelló, J.L. 000097469 700__ $$aRomero-Palmer, J.E. 000097469 700__ $$aSarmiento-Cruz, M. 000097469 700__ $$aArtigues, G. 000097469 700__ $$aMudrychova, J. 000097469 700__ $$aAlbaladejo-Blanco, M. 000097469 700__ $$aMoyá-Seguí, M.I. 000097469 700__ $$aVidal-Ribas, C. 000097469 700__ $$aLorente-Montalvo, P. 000097469 700__ $$aTorrens-Darder, I. 000097469 700__ $$aTorrens-Darder, M.M. 000097469 700__ $$aPascual-Calleja, L. 000097469 700__ $$aÁlvarez-Miguel, M.J. 000097469 700__ $$ade Arriba-Gómez, M.D. 000097469 700__ $$aRodríguez-Fernández, M.Á. 000097469 700__ $$aArranz-Hernando, I. 000097469 700__ $$aRamos-De la Torre, S. 000097469 700__ $$aArqueaga-Luengo, A. 000097469 700__ $$aMoreno-Moreno, M.E. 000097469 700__ $$aMarcos-García, A. 000097469 700__ $$aManrique-Vinagre, N. 000097469 700__ $$aPalomo-Blazquez, N. 000097469 700__ $$aMontalvillo-Montalvillo, J.L. 000097469 700__ $$aFernández-Rodríguez, M.E. 000097469 700__ $$aGonzález-Moro, A. 000097469 700__ $$aSantiago-Pastor, M. 000097469 700__ $$aPérez-Concejo, M.I. 000097469 700__ $$aRubio-Fernández, A. 000097469 700__ $$aGomez-Arranz, A. 000097469 700__ $$aFernandez-Alonso, C. 000097469 700__ $$aRodriguez-Dominguez, D. 000097469 700__ $$aRepiso-Gento, I. 000097469 700__ $$ade la Cal-De la Fuente, A. 000097469 700__ $$aAragon-Garcia, R. 000097469 700__ $$aDiez-Garcia, M.A. 000097469 700__ $$aIbañes-Jalon, E. 000097469 700__ $$aCastrillo-Sanz, I. 000097469 700__ $$aCorcho-Castaño, A.M. 000097469 700__ $$aJimenez-Lopez, E. 000097469 700__ $$aCorrea-Gonzalez, D. 000097469 700__ $$aBarruso-Villafaina, L. 000097469 700__ $$aPeña-Garcia, I. 000097469 700__ $$aEscudero-Terron, D. 000097469 700__ $$aMena-Martin, P. 000097469 700__ $$aFraile-Gomez, R. 000097469 700__ $$aAlonso-Gomez, A. 000097469 700__ $$aUrueña, P. 000097469 700__ $$aMartinez-Bermejo, F. 000097469 700__ $$aHernandez-San Jose, C. 000097469 700__ $$aNuñez-Gomez, M. 000097469 700__ $$aSanz-Capdepont, P. 000097469 700__ $$aPazos-Revuelta, A.I. 000097469 700__ $$aPerez-Niño, S. 000097469 700__ $$aJunquera-Del Pozo, M.E. 000097469 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. 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