Effectiveness 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)

Cristina Lugones-Sanchez, Maria Antonia Sanchez-Calavera, Irene Repiso-Gento, Esther G Adalia, J Ignacio Ramirez-Manent, Cristina Agudo-Conde, Emiliano Rodriguez-Sanchez, Manuel Angel Gomez-Marcos, Jose I Recio-Rodriguez, Luis Garcia-Ortiz, EVIDENT 3 Investigators, Cristina Lugones-Sanchez, Maria Antonia Sanchez-Calavera, Irene Repiso-Gento, Esther G Adalia, J Ignacio Ramirez-Manent, Cristina Agudo-Conde, Emiliano Rodriguez-Sanchez, Manuel Angel Gomez-Marcos, Jose I Recio-Rodriguez, Luis Garcia-Ortiz, EVIDENT 3 Investigators

Abstract

Background: 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.

Trial registration: Clinicaltrials.gov NCT03175614; https://ichgcp.net/clinical-trials-registry/NCT03175614.

International registered report identifier (irrid): RR2-10.1097/MD.0000000000009633.

Keywords: body fat distribution; diet records; electric impedance; mobile app; obesity; telemedicine; weight control.

Conflict of interest statement

Conflicts of Interest: None declared.

©Cristina Lugones-Sanchez, Maria Antonia Sanchez-Calavera, Irene Repiso-Gento, Esther G Adalia, J Ignacio Ramirez-Manent, Cristina Agudo-Conde, Emiliano Rodriguez-Sanchez, Manuel Angel Gomez-Marcos, Jose I Recio-Rodriguez, Luis Garcia-Ortiz, EVIDENT 3 Investigators. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 26.11.2020.

Figures

Figure 1
Figure 1
Flow chart depicting study enrolment and completion.
Figure 2
Figure 2
EVIDENT app feedback information.
Figure 3
Figure 3
Adherence to the EVIDENT smartphone app (number of days with a record in the app).
Figure 4
Figure 4
Evolution over time of main body composition variables. (A) Weight. (B) BMI. (C) Body fat mass. (D) Percentage of body fat.

References

    1. World Health Organization. Obesity and overweight. [2020-02-15]. .
    1. Marques A, Peralta M, Naia A, Loureiro N, de MMG. Prevalence of adult overweight and obesity in 20 European countries, 2014. Eur J Public Health. 2018 Apr 01;28(2):295–300. doi: 10.1093/eurpub/ckx143.
    1. Hernáez Á, Zomeño MD, Dégano IR, Pérez-Fernández S, Goday A, Vila J, Civeira F, Moure R, Marrugat J. Exceso de peso en España: situación actual, proyecciones para 2030 y sobrecoste directo estimado para el Sistema Nacional de Salud. Revista Española de Cardiología. 2019 Nov;72(11):916–924. doi: 10.1016/j.recesp.2018.07.009.
    1. Garg SK, Maurer H, Reed K, Selagamsetty R. Diabetes and cancer: two diseases with obesity as a common risk factor. Diabetes Obes Metab. 2014 Feb;16(2):97–110. doi: 10.1111/dom.12124. doi: 10.1111/dom.12124.
    1. Lavie CJ, McAuley PA, Church TS, Milani RV, Blair SN. Obesity and cardiovascular diseases: implications regarding fitness, fatness, and severity in the obesity paradox. J Am Coll Cardiol. 2014 Apr 15;63(14):1345–54. doi: 10.1016/j.jacc.2014.01.022.
    1. World Health Organization . Obesity: Preventing and managing the global epidemic: report of a WHO consultation. Geneva: WHO Report Series; 2000.
    1. Khaylis A, Yiaslas T, Bergstrom J, Gore-Felton C. A review of efficacious technology-based weight-loss interventions: five key components. Telemed J E Health. 2010 Nov;16(9):931–8. doi: 10.1089/tmj.2010.0065.
    1. Wadden TA, Butryn ML, Wilson C. Lifestyle modification for the management of obesity. Gastroenterology. 2007 May;132(6):2226–38. doi: 10.1053/j.gastro.2007.03.051.
    1. Rose SA, Poynter PS, Anderson JW, Noar SM, Conigliaro J. Physician weight loss advice and patient weight loss behavior change: a literature review and meta-analysis of survey data. Int J Obes (Lond) 2013 Jan;37(1):118–28. doi: 10.1038/ijo.2012.24.
    1. Kahan SI. Practical Strategies for Engaging Individuals With Obesity in Primary Care. Mayo Clin Proc. 2018 Mar;93(3):351–359. doi: 10.1016/j.mayocp.2018.01.006.
    1. Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: a systematic review of reviews. Int J Med Inform. 2010 Nov;79(11):736–71. doi: 10.1016/j.ijmedinf.2010.08.006.
    1. Zhang W, Cheng B, Zhu W, Huang X, Shen C. Effect of Telemedicine on Quality of Care in Patients with Coexisting Hypertension and Diabetes: A Systematic Review and Meta-Analysis. Telemed J E Health. 2020 Sep 23; doi: 10.1089/tmj.2020.0122.
    1. Budman SH, Portnoy D, Villapiano AJ. How to get technological innovation used in behavioral health care: Build it and they still might not come. Psychotherapy: Theory, Research, Practice, Training. 2003;40(1-2):45–54. doi: 10.1037/0033-3204.40.1-2.45.
    1. Chen J, Cade JE, Allman-Farinelli M. The Most Popular Smartphone Apps for Weight Loss: A Quality Assessment. JMIR Mhealth Uhealth. 2015;3(4):e104. doi: 10.2196/mhealth.4334.
    1. Levine DM, Savarimuthu S, Squires A, Nicholson J, Jay M. Technology-assisted weight loss interventions in primary care: a systematic review. J Gen Intern Med. 2015 Jan;30(1):107–17. doi: 10.1007/s11606-014-2987-6.
    1. Bennett GG, Steinberg D, Askew S, Levine E, Foley P, Batch BC, Svetkey LP, Bosworth HB, Puleo EM, Brewer A, DeVries A, Miranda H. Effectiveness of an App and Provider Counseling for Obesity Treatment in Primary Care. Am J Prev Med. 2018 Dec;55(6):777–786. doi: 10.1016/j.amepre.2018.07.005.
    1. Wang Y, Xue H, Huang Y, Huang L, Zhang D. A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. Adv Nutr. 2017 May;8(3):449–462. doi: 10.3945/an.116.014100.
    1. Wycherley TP, Noakes M, Clifton PM, Cleanthous X, Keogh JB, Brinkworth GD. A high-protein diet with resistance exercise training improves weight loss and body composition in overweight and obese patients with type 2 diabetes. Diabetes Care. 2010 May;33(5):969–76. doi: 10.2337/dc09-1974.
    1. Quist JS, Rosenkilde M, Petersen MB, Gram AS, Sjödin A, Stallknecht B. Effects of active commuting and leisure-time exercise on fat loss in women and men with overweight and obesity: a randomized controlled trial. Int J Obes (Lond) 2018 Mar;42(3):469–478. doi: 10.1038/ijo.2017.253.
    1. Newton RL, Carter LA, Johnson W, Zhang D, Larrivee S, Kennedy BM, Harris M, Hsia DS. A Church-Based Weight Loss Intervention in African American Adults using Text Messages (LEAN Study): Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Aug 24;20(8):e256. doi: 10.2196/jmir.9816.
    1. Jakicic JM, Davis KK, Rogers RJ, King WC, Marcus MD, Helsel D, Rickman AD, Wahed AS, Belle SH. Effect of Wearable Technology Combined With a Lifestyle Intervention on Long-term Weight Loss: The IDEA Randomized Clinical Trial. JAMA. 2016 Sep 20;316(11):1161–1171. doi: 10.1001/jama.2016.12858.
    1. Ventura Marra M, Lilly C, Nelson K, Woofter D, Malone J. A Pilot Randomized Controlled Trial of a Telenutrition Weight Loss Intervention in Middle-Aged and Older Men with Multiple Risk Factors for Cardiovascular Disease. Nutrients. 2019 Jan 22;11(2):229. doi: 10.3390/nu11020229.
    1. Romero-Corral A, Somers VK, Sierra-Johnson J, Thomas RJ, Collazo-Clavell ML, Korinek J, Allison TG, Batsis JA, Sert-Kuniyoshi FH, Lopez-Jimenez F. Accuracy of body mass index in diagnosing obesity in the adult general population. Int J Obes (Lond) 2008 Jun;32(6):959–66. doi: 10.1038/ijo.2008.11.
    1. Müller MJ, Braun W, Enderle J, Bosy-Westphal A. Beyond BMI: Conceptual Issues Related to Overweight and Obese Patients. Obes Facts. 2016;9(3):193–205. doi: 10.1159/000445380.
    1. Sun G, French CR, Martin GR, Younghusband B, Green RC, Xie Y, Mathews M, Barron JR, Fitzpatrick DG, Gulliver W, Zhang H. Comparison of multifrequency bioelectrical impedance analysis with dual-energy X-ray absorptiometry for assessment of percentage body fat in a large, healthy population. Am J Clin Nutr. 2005 Jan;81(1):74–8. doi: 10.1093/ajcn/81.1.74.
    1. Fox CS, Massaro JM, Hoffmann U, Pou KM, Maurovich-Horvat P, Liu C, Vasan RS, Murabito JM, Meigs JB, Cupples LA, D'Agostino RB, O'Donnell CJ. Abdominal visceral and subcutaneous adipose tissue compartments: association with metabolic risk factors in the Framingham Heart Study. Circulation. 2007 Jul 03;116(1):39–48. doi: 10.1161/CIRCULATIONAHA.106.675355.
    1. Recio-Rodriguez JI, Gómez-Marcos MA, Agudo-Conde C, Ramirez I, Gonzalez-Viejo N, Gomez-Arranz A, Salcedo-Aguilar F, Rodriguez-Sanchez E, Alonso-Domínguez R, Sánchez-Aguadero N, Gonzalez-Sanchez J, Garcia-Ortiz L, EVIDENT 3 investigators 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. Medicine (Baltimore) 2018 Jan;97(2):e9633. doi: 10.1097/MD.0000000000009633. doi: 10.1097/MD.0000000000009633.
    1. Recio-Rodríguez JI, Martín-Cantera C, González-Viejo N, Gómez-Arranz A, Arietaleanizbeascoa MS, Schmolling-Guinovart Y, Maderuelo-Fernandez JA, Pérez-Arechaederra D, Rodriguez-Sanchez E, Gómez-Marcos MA, García-Ortiz L. Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol. BMC Public Health. 2014;14:254. doi: 10.1186/1471-2458-14-254.
    1. Voils CI, Olsen MK, Gierisch JM, McVay MA, Grubber JM, Gaillard L, Bolton J, Maciejewski ML, Strawbridge E, Yancy WS. Maintenance of Weight Loss After Initiation of Nutrition Training: A Randomized Trial. Ann Intern Med. 2017 Apr 04;166(7):463–471. doi: 10.7326/M16-2160.
    1. Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen W, Smith SC, Tomaselli GF, American COCHATFOPG, Obesity S. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102–38. doi: 10.1161/.
    1. Salas-Salvadó J, Rubio MA, Barbany M, Moreno B, Grupo Colaborativo de la SEEDO [SEEDO 2007 Consensus for the evaluation of overweight and obesity and the establishment of therapeutic intervention criteria] Med Clin (Barc) 2007 Feb 10;128(5):184–96; quiz 1 p following 200. doi: 10.1016/s0025-7753(07)72531-9.
    1. Karelis AD, Chamberland G, Aubertin-Leheudre M, Duval C, Ecological mobility in AgingParkinson (EMAP) group Validation of a portable bioelectrical impedance analyzer for the assessment of body composition. Appl Physiol Nutr Metab. 2013 Jan;38(1):27–32. doi: 10.1139/apnm-2012-0129.
    1. Román Viñas B, Ribas Barba L, Ngo J, Serra Majem L. [Validity of the international physical activity questionnaire in the Catalan population (Spain)] Gac Sanit. 2013;27(3):254–7. doi: 10.1016/j.gaceta.2012.05.013.
    1. Raidl M, Spain K, Lanting R, Lockard M, Johnson S, Spencer M, Sant L, Welch J, Liddil A, Hartman-Cunningham M. The healthy diabetes plate. Prev Chronic Dis. 2007 Jan;4(1):A12.
    1. RedBedca. AESAN BEDCA. Base de datos Española de composición de alimentos. [2020-02-15].
    1. Bauman AE, Reis RS, Sallis JF, Wells JC, Loos RJF, Martin BW, Lancet PASWG. Correlates of physical activity: why are some people physically active and others not? Lancet. 2012 Jul 21;380(9838):258–71. doi: 10.1016/S0140-6736(12)60735-1.
    1. Linde JA, Rothman AJ, Baldwin AS, Jeffery RW. The impact of self-efficacy on behavior change and weight change among overweight participants in a weight loss trial. Health Psychol. 2006 May;25(3):282–91. doi: 10.1037/0278-6133.25.3.282.
    1. Tudor-Locke C, Bassett DR. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1–8.
    1. Melchart D, Löw P, Wühr E, Kehl V, Weidenhammer W. Effects of a tailored lifestyle self-management intervention (TALENT) study on weight reduction: a randomized controlled trial. Diabetes Metab Syndr Obes. 2017;10:235–245. doi: 10.2147/DMSO.S135572. doi: 10.2147/DMSO.S135572.
    1. Kim Y, Oh B, Shin H. Effect of mHealth With Offline Antiobesity Treatment in a Community-Based Weight Management Program: Cross-Sectional Study. JMIR Mhealth Uhealth. 2020 Jan 21;8(1):e13273. doi: 10.2196/13273.
    1. Toro-Ramos T, Lee D, Kim Y, Michaelides A, Oh TJ, Kim KM, Jang HC, Lim S. Effectiveness of a Smartphone Application for the Management of Metabolic Syndrome Components Focusing on Weight Loss: A Preliminary Study. Metab Syndr Relat Disord. 2017 Dec;15(9):465–473. doi: 10.1089/met.2017.0062.
    1. Yen H, Chiu H. The effectiveness of wearable technologies as physical activity interventions in weight control: A systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2019 Oct;20(10):1485–1493. doi: 10.1111/obr.12909.
    1. Cheatham SW, Stull KR, Fantigrassi M, Motel I. The efficacy of wearable activity tracking technology as part of a weight loss program: a systematic review. J Sports Med Phys Fitness. 2018 Apr;58(4):534–548. doi: 10.23736/S0022-4707.17.07437-0.
    1. DiFrancisco-Donoghue J, Jung M, Stangle A, Werner WG, Zwibel H, Happel P, Balentine J. Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. Prev Med Rep. 2018 Dec;12:122–127. doi: 10.1016/j.pmedr.2018.09.004.
    1. Hernández-Reyes A, Cámara-Martos F, Molina Recio G, Molina-Luque R, Romero-Saldaña M, Moreno Rojas R. Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e13747. doi: 10.2196/13747.
    1. French SA, Jeffery RW, Wing RR. Sex differences among participants in a weight-control program. Addict Behav. 1994;19(2):147–58. doi: 10.1016/0306-4603(94)90039-6.
    1. Livingstone KM, Celis-Morales C, Navas-Carretero S, San-Cristobal R, O'Donovan CB, Forster H, Woolhead C, Marsaux CFM, Macready AL, Fallaize R, Kolossa S, Tsirigoti L, Lambrinou CP, Moschonis G, Godlewska M, Surwiłło A, Drevon CA, Manios Y, Traczyk I, Gibney ER, Brennan L, Walsh MC, Lovegrove JA, Alfredo Martinez J, Saris WH, Daniel H, Gibney M, Mathers JC. Profile of European adults interested in internet-based personalised nutrition: the Food4Me study. Eur J Nutr. 2016 Mar;55(2):759–769. doi: 10.1007/s00394-015-0897-y.
    1. Pagoto SL, Schneider KL, Oleski JL, Luciani JM, Bodenlos JS, Whited MC. Male inclusion in randomized controlled trials of lifestyle weight loss interventions. Obesity (Silver Spring) 2012 Jun;20(6):1234–9. doi: 10.1038/oby.2011.140. doi: 10.1038/oby.2011.140.
    1. Slentz CA, Duscha BD, Johnson JL, Ketchum K, Aiken LB, Samsa GP, Houmard JA, Bales CW, Kraus WE. Effects of the amount of exercise on body weight, body composition, and measures of central obesity: STRRIDE--a randomized controlled study. Arch Intern Med. 2004 Jan 12;164(1):31–9. doi: 10.1001/archinte.164.1.31.
    1. Müller M J, Lagerpusch M, Enderle J, Schautz B, Heller M, Bosy-Westphal A. Beyond the body mass index: tracking body composition in the pathogenesis of obesity and the metabolic syndrome. Obes Rev. 2012 Dec;13 Suppl 2:6–13. doi: 10.1111/j.1467-789X.2012.01033.x.
    1. Expert Panel on Detection‚ Evaluation‚Treatment of High Blood Cholesterol in Adults Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III) JAMA. 2001 May 16;285(19):2486–97. doi: 10.1001/jama.285.19.2486.
    1. Amankwaah AF, Hudson JL, Kim JE, Campbell WW. Reductions in whole-body fat mass but not increases in lean mass predict changes in cardiometabolic health indices with exercise training among weight-stable adults. Nutr Res. 2019 Mar;63:63–69. doi: 10.1016/j.nutres.2018.11.004.
    1. Calling S, Hedblad B, Engström Gunnar, Berglund G, Janzon L. Effects of body fatness and physical activity on cardiovascular risk: risk prediction using the bioelectrical impedance method. Scand J Public Health. 2006;34(6):568–75. doi: 10.1080/14034940600595621.
    1. Moustgaard H, Clayton GL, Jones HE, Boutron I, Jørgensen Lars, Laursen DRT, Olsen MF, Paludan-Müller Asger, Ravaud P, Savović J, Sterne JAC, Higgins JPT, Hróbjartsson Asbjørn. Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study. BMJ. 2020 Jan 21;368:l6802. doi: 10.1136/bmj.l6802.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever